Arnuity Ellipta

Name: Arnuity Ellipta

What Is Arnuity Ellipta?

Fluticasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Fluticasone inhalation is used to prevent asthma attacks. Fluticasone inhalation will not treat an asthma attack that has already begun. Flovent HFA and Flovent Diskus are sometimes used together with an oral (taken by mouth) steroid medicine.

Flovent brands of fluticasone inhalation are for use in adults and children who are at least 4 years old. The Arnuity Ellipta brand is for adults and children who are at least 12 years old.

Fluticasone may also be used for purposes not listed in this medication guide.

Fluticasone inhalation is not a rescue medicine. It will not work fast enough to treat an asthma attack. Fluticasone inhalation is used only to prevent asthma attacks.

You should not use the inhalation powder (Arnuity Ellipta or Flovent Diskus) if you are allergic to milk proteins.

You should not use this medicine if you are allergic to fluticasone. Do not use the inhalation powder (Arnuity Ellipta or Flovent Diskus) if you are allergic to milk proteins.

Do not use fluticasone inhalation to treat an asthma attack that has already begun.

To make sure fluticasone inhalation is safe for you, tell your doctor if you have:

  • any type of infection (bacterial, viral, or fungal);
  • an infection caused by parasites (such as giardia, malaria, leishmaniasis, hookworm, pinworm, toxoplasmosis, and many others);
  • tuberculosis;
  • herpes infection of the eyes;
  • glaucoma or cataracts;
  • liver disease;
  • low bone mineral density; or
  • a weak immune system.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether fluticasone inhalation passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Fluticasone inhalation is not approved for use by anyone younger than 4 years old.

Do not give this medicine to a child without the advice of a doctor. Fluticasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Arnuity Ellipta Interactions

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • nefazodone;
  • an antibiotic--clarithromycin, erythromycin, telithromycin;
  • antifungal medication--itraconazole, ketoconazole, voriconazole;
  • HIV/AIDS medication--atazanavir, delavirdine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir; or
  • steroid medicines--dexamethasone, prednisone, or others.

This list is not complete. Other drugs may interact with fluticasone inhalation, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Arnuity Ellipta Overview

Arnuity Ellipta is a prescription medication used to prevent symptoms of asthma in children and adults over 12 years of age. Arnuity Ellipta belongs to a class of drugs called inhaled corticosteroids. These work to prevent asthma symptoms by decreasing swelling and irritation in the airways to allow for easier breathing.

Arnuity Ellipta comes in an inhaler form and is typically used once daily.

Common side effects of Arnuity Ellipta include irritation of the nose and/or throat, headache, and inflammation of the sinuses. 

 

Arnuity Ellipta Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Arnuity Ellipta, there are no specific foods that you must exclude from your diet when receiving this medication.

Arnuity Ellipta and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Arnuity Ellipta crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Arnuity Ellipta.

Before Using Arnuity Ellipta

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Corticosteroids taken by mouth or injection have been shown to slow or stop growth in children and cause reduced adrenal gland function. If enough fluticasone is absorbed following inhalation, it is possible it also could cause these effects. Your doctor will want you to use the lowest possible dose of fluticasone that controls asthma. This will lessen the chance of an effect on growth or adrenal gland function. It is also important that children taking fluticasone visit their doctors regularly so that their growth rates may be monitored. Children who are taking this medicine may be more susceptible to infections, such as chickenpox or measles. Care should be taken to avoid exposure to chickenpox or measles. If the child is exposed or the disease develops, the doctor should be contacted and his or her directions should be followed carefully. Before this medicine is given to a child, you and your child's doctor should talk about the good this medicine will do as well as the risks of using it.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving fluticasone. .

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atazanavir
  • Bemiparin
  • Boceprevir
  • Bupropion
  • Ceritinib
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Darunavir
  • Dasabuvir
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lumacaftor
  • Nadroparin
  • Nefazodone
  • Nelfinavir
  • Pixantrone
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Telithromycin
  • Tipranavir
  • Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma attack, acute or
  • Bronchospasm (difficulty with breathing), acute or
  • Milk protein allergy, severe—Should not be used in patients with these conditions.
  • Bone problems (eg, osteoporosis) or
  • Blood vessel disease (eg, Churg-Strauss syndrome) or
  • Cataracts or
  • Glaucoma—Use with caution. May make these conditions worse.
  • Chickenpox (including recent exposure) or
  • Herpes simplex (virus) infection of the eye or
  • Infections (virus, bacteria, or fungus) or
  • Measles or
  • Tuberculosis, active or history of—Inhaled fluticasone can reduce the body's ability to fight off these infections.
  • Infection or
  • Stress or
  • Surgery or
  • Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.
  • Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

How is this medicine (Arnuity Ellipta) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Follow how to use as you have been told by the doctor or read the package insert.
  • To gain the most benefit, do not miss doses.
  • Keep using Arnuity Ellipta (fluticasone inhalation powder) as you have been told by your doctor or other health care provider, even if you feel well.
  • Use this medicine at the same time of day.
  • For breathing in only.
  • Rinse out mouth after each use. Do not swallow the rinse water. Spit it out.
  • Have your puffer (inhaler) use checked with your doctor at each visit. Read and follow facts on how to use the puffer. Make sure you use the puffer the right way.
  • If using more than 1 type of puffer (inhaler), ask the doctor which puffer to use first.
  • Do not prepare a dose until you need to take it. If you prepare a dose and close the inhaler without taking a dose, it will waste the drug and may damage the inhaler.
  • Do not breathe out into the puffer (inhaler). Close the inhaler after you use your dose.
  • Do not take the device apart or wash it. Do not use it with a spacer. Do not breathe out into the device.
  • Clean mouthpiece by wiping with a dry tissue or cloth. Do not wash or put in water.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some other side effects of Arnuity Ellipta?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Feeling tired or weak.
  • Nose and throat irritation.
  • Flu-like signs.
  • Runny nose.
  • Nose stuffiness.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Contraindications

Status Asthmaticus

Arnuity Ellipta is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions (5.2)].

Hypersensitivity

Arnuity Ellipta is contraindicated in patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone furoate or any of the excipients [see Warnings and Precautions (5.8), Description (11)].

Warnings and Precautions

Local Effects of Inhaled Corticosteroids

In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in subjects treated with Arnuity Ellipta. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with Arnuity Ellipta continues, but at times therapy with Arnuity Ellipta may need to be interrupted. Advise the patient to rinse his/her mouth with water without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis.

Acute Asthma Episodes

Arnuity Ellipta is not indicated for the relief of acute symptoms, i.e., as rescue therapy for treatment of acute episodes of bronchospasm. An inhaled, short-acting beta2-agonist, not Arnuity Ellipta, should be used to relieve acute symptoms such as shortness of breath. When prescribing Arnuity Ellipta, the physician must provide the patient with an inhaled, short-acting beta2-agonist (e.g., albuterol) for treatment of acute symptoms, despite regular once-daily use of Arnuity Ellipta. Instruct patients to contact their physicians immediately if episodes of asthma not responsive to bronchodilators occur during the course of treatment with Arnuity Ellipta. During such episodes, patients may require therapy with oral corticosteroids.

Immunosuppression

Persons using drugs that suppress the immune system are more susceptible to infections than healthy individuals.

Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such patients who have not had these diseases or who have not been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Transferring Patients from Systemic Corticosteroid Therapy

Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Patients who have been previously maintained on 20 mg or more of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although Arnuity Ellipta may improve control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.

During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a medical identification warning card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack.

Patients requiring systemic corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Arnuity Ellipta. Lung function (forced expiratory volume in 1 second [FEV1] or morning peak expiratory flow [AM PEF]), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of systemic corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to Arnuity Ellipta may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions).

During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal (e.g., joint and/or muscular pain, lassitude, depression), despite maintenance or even improvement of respiratory function.

Hypercorticism and Adrenal Suppression

Arnuity Ellipta will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since Arnuity Ellipta is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of Arnuity Ellipta in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose.

Because of the possibility of significant systemic absorption of inhaled corticosteroids, patients treated with Arnuity Ellipta should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when fluticasone furoate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of Arnuity Ellipta should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.

Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors

Caution should be exercised when considering the coadministration of Arnuity Ellipta with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid adverse effects may occur [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Paradoxical Bronchospasm and Upper Airway Symptoms

As with other inhaled medicines, bronchospasm may occur with an immediate increase in wheezing after dosing. If bronchospasm occurs following dosing with Arnuity Ellipta, it should be treated immediately with an inhaled, short-acting bronchodilator; Arnuity Ellipta should be discontinued immediately; and alternative therapy should be instituted.

Hypersensitivity Reactions, Including Anaphylaxis

Hypersensitivity reactions such as urticaria, flushing, allergic dermatitis, and bronchospasm may occur after administration of Arnuity Ellipta. Discontinue Arnuity Ellipta if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of other powder products containing lactose; therefore, patients with severe milk protein allergy should not use Arnuity Ellipta [see Contraindications (4.2)].

Reduction in Bone Mineral Density

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. The clinical significance of small changes in BMD with regard to long-term outcomes, such as fracture, is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids), should be monitored and treated with established standards of care.

Effect on Growth

Orally inhaled corticosteroids, including Arnuity Ellipta, may cause a reduction in growth velocity when administered to children and adolescents. Monitor the growth of children and adolescents receiving Arnuity Ellipta routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including Arnuity Ellipta, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].

Glaucoma and Cataracts

Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long‑term administration of inhaled corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Clinical Studies

The safety and efficacy of Arnuity Ellipta were evaluated in 3,611 subjects with asthma. The development program included 4 confirmatory trials of 3 and 6 months’ duration and 3 dose-ranging trials of 8 weeks’ duration. The efficacy of Arnuity Ellipta is based primarily on the dose-ranging trials and the confirmatory trials described below.

Dose-Ranging Trials

Eight doses of fluticasone furoate ranging from 25 to 800 mcg once daily were evaluated in 3 randomized, double-blind, placebo-controlled, 8-week trials in subjects with asthma. Across the 3 trials, subjects were uncontrolled at baseline on treatments of short-acting beta2-agonist and/or non-corticosteroid controller medications (Trial 687), low-dose inhaled corticosteroid (Trial 685), or medium doses of inhaled corticosteroid (Trial 684). The trials in Figure 3 were dose-ranging trials of Arnuity Ellipta not designed to provide comparative effectiveness data and should not be interpreted as evidence of superiority/inferiority to fluticasone propionate. A dose-related increase in trough FEV1 at Week 8 was seen for doses from 25 to 200 mcg with no consistent additional benefit for doses above 200 mcg as seen in Figure 3. To evaluate dosing frequency, a separate trial compared fluticasone furoate 200 mcg once daily, fluticasone furoate 100 mcg twice daily, fluticasone propionate 100 mcg twice daily, and fluticasone propionate 200 mcg once daily. The results supported the selection of the once-daily dosing frequency.

Figure 3. Dose-Ranging Trials

FF = Fluticasone furoate.

FP = Fluticasone propionate.

OD = Once daily.

BD = Twice daily.

Confirmatory Trials

The clinical development program for Arnuity Ellipta included 4 confirmatory trials in adolescent and adult subjects aged 12 years and older with asthma. The trials were designed to evaluate the safety and efficacy of Arnuity Ellipta given once daily in the evening on lung function in subjects who were not controlled on their current treatments of inhaled corticosteroids, or combination therapy consisting of an inhaled corticosteroid plus a LABA. Study treatments were delivered as inhalation powders. The primary endpoint in all trials was change from baseline in evening trough FEV1 measured approximately 24 hours after the final dose of study medication. Trough FEV1 (assessed at approximately 24 hours after the previous dose) was also assessed at clinic visits throughout the trials. Trials 2 and 4 had a co-primary endpoint of change from baseline in weighted mean serial FEV1 measured after the final dose of study medication at 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours post-dose.

Clinical Trials with Arnuity Ellipta 100 mcg: Trial 1 was a 24-week trial that evaluated the efficacy of Arnuity Ellipta 100 mcg compared with placebo on lung function in subjects with asthma. Inhaled fluticasone propionate 250 mcg twice daily was included as an active control. Of the 343 subjects, 59% were female and 79% were Caucasian. The mean age was 41 years. The trial included a 4-week run-in period during which the subjects were symptomatic while taking their usual low- to mid-dose inhaled corticosteroid therapy (i.e., fluticasone propionate 100 to 500 mcg daily or equivalent). Mean baseline percent predicted FEV1 was approximately 73% overall and was similar across the 3 treatment groups. Thirty-five percent of subjects on placebo and 19% of subjects on Arnuity Ellipta 100 mcg failed to complete the 24-week trial.

The change in trough FEV1 from baseline to Week 24, or the last available on-treatment visit prior to Week 24, was assessed to evaluate the efficacy of Arnuity Ellipta 100 mcg. The mean change from baseline in trough FEV1 was greater among subjects receiving Arnuity Ellipta 100 mcg than among those receiving placebo (mean treatment difference from placebo 146 mL; 95% CI: 36, 257) as shown in Table 3.

Table 3. Change from Baseline in Trough FEV1 (mL) at Week 24 – Trial 1

Trough FEV1 (Week 24)

Placebo

(n = 113)

Arnuity Ellipta

100 mcg

(n = 111)

Fluticasone Propionate

250 mcg Twice Daily

(n = 107)

Least squares mean

2,372

2,519

2,517

Least squares mean change (SE)

15 (39.4)

161 (39.8)

159 (40.6)

Column vs. placebo

  Difference

146

145

  95% CI

36, 257

33, 257

  P value

0.009

0.011

Trial 2 was a 12-week trial that evaluated the efficacy of Arnuity Ellipta 100 mcg on lung function in subjects with asthma compared with placebo. The combination of fluticasone furoate 100 mcg and vilanterol 25 mcg was also included as a treatment arm. Of the 609 subjects, 58% were female and 84% were Caucasian. The mean age was 40 years. The trial included a 4-week run-in period during which the subjects were symptomatic while taking their usual low- to mid-dose inhaled corticosteroid (fluticasone propionate 200 to 500 mcg/day or equivalent). If LABA were used prior to screening, their use was discontinued during the run-in. Mean baseline percent predicted FEV1 was approximately 70% in both treatment groups. Twenty-six percent of subjects on placebo and 10% of subjects on Arnuity Ellipta 100 mcg failed to complete the 12-week trial.

The co-primary efficacy endpoints in Trial 2 were change from baseline in trough FEV1 at Week 12 and weighted mean FEV1 (0-24 hours) at the end of the 12-week treatment period. Trough FEV1 was assessed at clinic visits throughout the trial. Weighted mean FEV1 (0-24 hours) was recorded at baseline and after the final study dose with serial measurements taken at frequent intervals (at 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours post-dose) in a subset of subjects (n = 201).

Arnuity Ellipta 100 mcg once daily had greater mean changes from baseline in trough FEV1 than placebo throughout the trial. At Week 12 or the last available on-treatment visit prior to Week 12, the mean change from baseline in trough FEV1 was greater among subjects receiving Arnuity Ellipta 100 mcg once daily than among those receiving placebo (mean treatment difference 136 mL; 95% CI: 51, 222).

Lung function improvements were sustained over the 24-hour period following the final dose of Arnuity Ellipta 100 mcg (see Figure 4). Compared with placebo, at Week 12 the change from baseline in weighted mean FEV1 was significantly greater for Arnuity Ellipta 100 mcg (mean treatment difference 186 mL; 95% CI: 62, 310).

Figure 4. Mean Change from Baseline in Individual Serial FEV1 (mL) Assessments after 12 Weeks of Treatment – Trial 2

Subjects in both Trials 1 and 2 receiving Arnuity Ellipta 100 mcg once daily had a greater improvement from baseline in percentage of 24-hour periods without need of beta2-agonist rescue medication use than subjects receiving placebo.

Clinical Trial with Arnuity Ellipta 200 mcg: Trial 3 was a 24-week trial that evaluated the relative efficacy of Arnuity Ellipta 100 mcg and Arnuity Ellipta 200 mcg on lung function in subjects with asthma. Of the 219 subjects, 68% were female and 87% were Caucasian. The mean age was 46 years. The trial included a 4-week run-in period during which the subjects were symptomatic while taking their usual mid- to high-dose inhaled corticosteroid therapy (i.e., fluticasone propionate greater than 250 to 1,000 mcg/day or equivalent). If LABA were used prior to screening, their use was discontinued during the run-in. Mean baseline percent predicted FEV1 was approximately 68% overall and similar in the 2 treatment groups. Sixteen percent of subjects on Arnuity Ellipta 100 mcg and 13% of subjects on Arnuity Ellipta 200 mcg failed to complete the 24-week trial.

The primary efficacy endpoint was mean change from baseline in trough FEV1 at Week 24. There were trends toward greater mean changes from baseline in the group receiving Arnuity Ellipta 200 mcg than the group receiving Arnuity Ellipta 100 mcg throughout the trial (see Figure 5). At Week 24 or the last available on-treatment visit prior to Week 24, the mean change from baseline in trough FEV1 was 208 mL for Arnuity Ellipta 100 mcg, as compared to 284 mL for Arnuity Ellipta 200 mcg (difference of 77 mL; 95% CI: -39, 192) as seen in Figure 5.

Figure 5. Mean Change from Baseline in Trough FEV1 (mL) over Time – Trial 3

Trial 4 was a 24-week trial that evaluated the efficacy of Arnuity Ellipta 200 mcg once daily and fluticasone propionate 500 mcg twice daily on lung function in subjects with asthma. The combination of fluticasone furoate 200 mcg and vilanterol 25 mcg was also included as a treatment arm (data not shown). Of the 586 subjects, 59% were female and 84% were Caucasian. The mean age was 46 years. The trial included a 4-week run-in period during which the subjects were symptomatic while taking their usual mid- to high-dose inhaled corticosteroid (fluticasone propionate 500 to 1,000 mcg/day or equivalent). If LABA were used prior to screening, their use was discontinued during the run-in. Mean baseline percent predicted FEV1 was approximately 67% in both treatment groups.

Both Arnuity Ellipta 200 mcg once daily and fluticasone propionate 500 mcg twice daily produced improvement from baseline in lung function. At Week 24 the mean change from baseline in trough FEV1 was 201 mL for Arnuity Ellipta 200 mcg once daily and 183 mL for fluticasone propionate 500 mcg twice daily (treatment difference of 18 mL, 95% CI: -66, 102).

Lung function improvements were sustained over the 24-hour period following the final dose of Arnuity Ellipta 200 mcg (see Figure 6). At Week 24, the change from baseline in weighted mean FEV1 was 328 mL for Arnuity Ellipta 200 mcg once daily and 258 mL for fluticasone propionate 500 twice daily (difference of 70 mL; 95% CI: -67, 208).

Figure 6. Mean Change from Baseline in Individual Serial FEV1 (mL) Assessments after 24 Weeks of Treatment – Trial 4

General information

Medicines are sometimes prescribed for purposes not mentioned in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same condition that you have. It may harm them.

This Patient Information leaflet summarizes the most important information. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information that was written for healthcare professionals.

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