Incruse Ellipta Drug Information

Generic name: UMECLIDINIUM

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Uses of Incruse Ellipta

is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). INCRUSE ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Dosage & Administration of Incruse Ellipta

  • The recommended dosage of INCRUSE ELLIPTA for maintenance treatment of COPD is 1 actuation (umeclidinium 62.5 mcg) once daily by oral inhalation.
  • INCRUSE ELLIPTA should be used at the same time every day. Do not use INCRUSE ELLIPTA more than 1 time every 24 hours.
  • No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment [see Clinical Pharmacology ( 12.3 )] .
  • For oral inhalation only. ( 2 )
  • Maintenance treatment of COPD: 1 actuation of INCRUSE ELLIPTA once daily administered by oral inhalation. ( 2 )

Side Effects of Incruse Ellipta

  • The following adverse reactions are described in greater detail in other sections:
  • Paradoxical bronchospasm [see Warnings and Precautions ( 5.2 )]
  • Worsening of narrow-angle glaucoma [see Warnings and Precautions ( 5.4 )]
  • Worsening of urinary retention [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence ≥2% and more common than placebo) include nasopharyngitis, upper respiratory tract infection, cough, arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the 8 clinical trials conducted to support initial approval of INCRUSE ELLIPTA, a total of 1,663 subjects with COPD (mean age: 62.7 years; 89% white; 65% male across all treatments, including placebo) received at least 1 inhalation dose of umeclidinium at doses of 62.5 or 125 mcg. In the 4 randomized, double-blind, placebo- or active-controlled, efficacy clinical trials, 1,185 subjects received umeclidinium for up to 24 weeks, of which 487 subjects received the recommended dose of umeclidinium 62.5 mcg. In a 12-month, randomized, double-blind, placebo-controlled, long-term safety trial, 227 subjects received umeclidinium 125 mcg for up to 52 weeks [see Clinical Studies ( 14 )] . The incidence of adverse reactions associated with INCRUSE ELLIPTA in Table 1 is based upon 2 placebo-controlled trials: one 24-week trial (Trial 1) and one 12-week trial (Trial 2) [ see Clinical Studies (14.2)]. Table 1. Adverse Reactions with INCRUSE ELLIPTA with ≥1% Incidence and More Common than Placebo in Subjects with Chronic Obstructive Pulmonary Disease Adverse Reaction INCRUSE ELLIPTA (n = 487) % Placebo (n = 348) % Infections and infestations Nasopharyngitis 8% 7% Upper respiratory tract infection 5% 4% Pharyngitis 1% <1% Viral upper respiratory tract infection 1% <1% Respiratory, thoracic, and mediastinal disorders Cough 3% 2% Musculoskeletal and connective tissue disorders Arthralgia 2% 1% Myalgia 1% <1% Gastrointestinal disorders Abdominal pain upper 1% <1% Toothache 1% <1% Injury, poisoning, and procedural complications Contusion 1% <1% Cardiac disorders Tachycardia 1% <1% Other adverse reactions with INCRUSE ELLIPTA observed with an incidence <1% but more common than placebo included atrial fibrillation. In a long-term safety trial (Trial 3), 336 subjects (n = 227 umeclidinium 125 mcg, n = 109 placebo) were treated for up to 52 weeks with umeclidinium 125 mcg or placebo. The demographic and baseline characteristics of the long-term safety trial were similar to those of the efficacy trials described above. Adverse reactions that occurred with a frequency ≥1% in subjects receiving umeclidinium 125 mcg that exceeded that in placebo in this trial were: nasopharyngitis, upper respiratory tract infection, urinary tract infection, pharyngitis, pneumonia, lower respiratory tract infection, rhinitis, supraventricular tachycardia, supraventricular extrasystoles, sinus tachycardia, idioventricular rhythm, headache, dizziness, sinus headache, cough, back pain, arthralgia, pain in extremity, neck pain, myalgia, nausea, dyspepsia, diarrhea, rash, depression, and vertigo. The safety and efficacy of INCRUSE ELLIPTA in combination with an inhaled corticosteroid/long-acting beta 2 -adrenergic agonist (ICS/LABA) were also evaluated in four 12‑week clinical trials (Trial 4, Trial 5, Trial 6, and Trial 7). A total of 1,637 subjects with COPD across four 12‑week, randomized, double-blind clinical trials received at least 1 dose of INCRUSE ELLIPTA (62.5 mcg) or placebo administered once daily in addition to background ICS/LABA (mean age: 64 years, 88% white, 65% male across all treatments). Two trials (Trials 4 and 5) evaluated INCRUSE ELLIPTA in combination with fluticasone furoate/vilanterol (FF/VI) 100 mcg/25mcg administered once daily, and 2 trials (Trials 6 and 7) evaluated INCRUSE ELLIPTA administered once daily in combination with fluticasone propionate/salmeterol (FP/SAL) 250 mcg/50 mcg administered twice daily [see Clinical Studies ( 14.3 )] . Adverse reactions that occurred with INCRUSE ELLIPTA in combination with an ICS/LABA were similar to those reported with INCRUSE ELLIPTA as monotherapy. In addition to the umeclidinium monotherapy adverse reactions reported above, adverse reactions occurring with INCRUSE ELLIPTA in combination with an ICS/LABA, at an incidence of ≥1% and exceeding ICS/LABA alone, were oropharyngeal pain and dysgeusia. 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of INCRUSE ELLIPTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to INCRUSE ELLIPTA or a combination of these factors. Eye Disorders Eye pain, glaucoma, vision blurred. Immune System Disorders Hypersensitivity reactions, including anaphylaxis, angioedema, pruritus, and urticaria. Renal and Urinary Disorders Dysuria, urinary retention. Respiratory, Thoracic and Mediastinal Disorders Dysphonia, oropharyngeal pain.

Warnings & Cautions for Incruse Ellipta

  • Do not initiate in acutely deteriorating COPD. Do not use to treat acute symptoms. ( 5.1 )
  • If paradoxical bronchospasm occurs, discontinue INCRUSE ELLIPTA and institute alternative therapy. ( 5.2 )
  • Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.4 )
  • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.5 ) 5.1 Deterioration of Disease and Acute Episodes INCRUSE ELLIPTA should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD. INCRUSE ELLIPTA has not been studied in subjects with acutely deteriorating COPD. The initiation of INCRUSE ELLIPTA in this setting is not appropriate. INCRUSE ELLIPTA should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. INCRUSE ELLIPTA has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta 2 -agonist. If INCRUSE ELLIPTA no longer controls symptoms of bronchoconstriction; the patient’s inhaled, short-acting beta 2 -agonist becomes less effective; or the patient needs more short-acting beta 2 -agonist than usual, these may be markers of deterioration of disease. In this setting re-evaluate the patient and the COPD treatment regimen at once. Increasing the daily dose of INCRUSE ELLIPTA beyond the recommended dose is not appropriate in this situation. 5.2 Paradoxical Bronchospasm As with other inhaled therapies, INCRUSE ELLIPTA can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with INCRUSE ELLIPTA, it should be treated immediately with an inhaled, short-acting bronchodilator; INCRUSE ELLIPTA should be discontinued immediately; and alternative therapy should be instituted. 5.3 Hypersensitivity Reactions, including Anaphylaxis Hypersensitivity reactions such as anaphylaxis, angioedema, pruritus, rash, and urticaria may occur after administration of INCRUSE ELLIPTA. Discontinue INCRUSE ELLIPTA if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of other powder medications containing lactose; therefore, patients with severe milk protein allergy should not use INCRUSE ELLIPTA [see Contraindications ( 4 ), Adverse Reactions ( 6.2 )] . 5.4 Worsening of Narrow-Angle Glaucoma INCRUSE ELLIPTA should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should also be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a healthcare provider immediately if any of these signs or symptoms develop. 5.5 Worsening of Urinary Retention INCRUSE ELLIPTA, like all therapies containing an anticholinergic, should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a healthcare provider immediately if any of these signs or symptoms develop.

Drug Interactions with Incruse Ellipta

Anticholinergics

There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of INCRUSE ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects .

Pregnancy Safety for Incruse Ellipta

Pregnancy Risk Summary There are insufficient data on the use of umeclidinium in pregnant women to inform a drug‑associated risk. Umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effect on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled dose (MRHDID). (See Data.) The estimated risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data: In separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 50 and 200 times the MRHDID, respectively (on an AUC basis at maternal inhalation doses up to 278 mcg/kg/day in rats and at maternal subcutaneous doses up to 180 mcg/kg/day in rabbits). No evidence of teratogenic effects was observed in either species. In a perinatal and postnatal developmental study in rats, dams received umeclidinium during late gestation and lactation periods with no evidence of effects on offspring development at doses up to approximately 26 times the MRHDID (on an AUC basis at maternal subcutaneous doses up to 60 mcg/kg/day).

Pediatric Use of Incruse Ellipta

Pediatric Use The safety and effectiveness of INCRUSE ELLIPTA have not been established in pediatric patients. INCRUSE ELLIPTA is not indicated for use in pediatric patients.

Contraindications for Incruse Ellipta

  • is contraindicated in the following conditions:
  • Severe hypersensitivity to milk proteins [see Warnings and Precautions ( 5.3 )]
  • Hypersensitivity to umeclidinium or any of the excipients [see Warnings and Precautions ( 5.3 ), Description ( 11 )]
  • Severe hypersensitivity to milk proteins. ( 4 )
  • Hypersensitivity to any ingredient. ( 4 )

Overdosage Information for Incruse Ellipta

High doses of umeclidinium may lead to anticholinergic signs and symptoms. Treatment of overdosage consists of discontinuation of INCRUSE ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy.

Clinical Studies of Incruse Ellipta

Dose-Ranging Trials Dose selection for umeclidinium in

COPD was supported by a 7-day, randomized, double-blind, placebo-controlled, crossover trial evaluating 4 doses of umeclidinium (15.6 to 125 mcg) or placebo dosed once daily in the morning in 163 subjects with COPD. A dose ordering was observed, with the 62.5- and 125-mcg doses demonstrating larger improvements in FEV 1 over 24 hours compared with the lower doses of 15.6 and 31.25 mcg (Figure 2). The differences in trough FEV 1 from baseline after 7 days for placebo and the 15.6-, 31.25-, 62.5-, and 125-mcg doses were -74 mL (95% CI: -118, -31), 38 mL (95% CI: -6, 83), 27 mL (95% CI: -18, 72), 49 mL (95% CI: 6, 93), and 109 mL (95% CI: 65, 152), respectively. Two additional dose-ranging trials in subjects with COPD demonstrated minimal additional benefit at doses above 125 mcg. The dose-ranging results supported the evaluation of 2 doses of umeclidinium, 62.5 and 125 mcg, in the confirmatory COPD trials to further assess dose response.

Evaluations of dosing interval by comparing once- and twice-daily dosing supported selection of a once-daily dosing interval for further evaluation in the confirmatory COPD trials. Figure 2. Adjusted Mean Change from Baseline in Postdose Serial FEV 1 (mL) on Days 1 and 7 Day 1 Day 7 Figure 2. Adjusted Mean Change from Baseline in Postdose Serial FEV1 (mL) on Days 1 and 7, Day 1 Figure 2. Adjusted Mean Change from Baseline in Postdose Serial FEV1 (mL) on Days 1 and 7, Day 7

Maintenance Treatment: Confirmatory Trials Lung Function

The clinical development program for INCRUSE ELLIPTA included 2 randomized, double‑blind, placebo-controlled, parallel-group trials in subjects with COPD designed to evaluate the efficacy of INCRUSE ELLIPTA on lung function. Trial 1 (NCT01313650) was a 24-week placebo‑controlled trial, and Trial 2 (NCT01387230) was a 12-week placebo‑controlled trial. These trials treated subjects that had a clinical diagnosis of COPD, were 40 years of age or older, had a history of smoking ≥10 pack-years, had a post-albuterol FEV 1 ≤70% of predicted normal values, had a ratio of FEV 1 /FVC of <0.7, and had a Modified Medical Research Council (mMRC) score ≥2. Subjects in Trial 1 had a mean age of 63 years and an average smoking history of 46 pack-years, with 50% identified as current smokers.

At screening, the mean postbronchodilator percent predicted FEV 1 was 47% (range: 13% to 74%), the mean postbronchodilator FEV 1 /FVC ratio was 0.47 (range: 0.20 to 0.74), and the mean percent reversibility was 15% (range: -35% to 109%). The majority of subjects (72%) reported not having a COPD exacerbation in the prior 12 months. Baseline demographics and lung function for subjects in Trial 2 were similar to those in Trial 1. Trial 1 evaluated umeclidinium 62.5 mcg and placebo. The primary endpoint was change from baseline in trough (predose) FEV 1 at Day 169 (defined as the mean of the FEV 1 values obtained at 23 and 24 hours after the previous dose on Day 168) compared with placebo.

INCRUSE ELLIPTA 62.5 mcg demonstrated a larger increase in mean change from baseline in trough (predose) FEV 1 relative to placebo ( Table 2 ). Similar results were obtained from Trial 2. Table 2. Least Squares Mean Change from Baseline in Trough FEV 1 (mL) at Day 169 in the Intent-to-Treat Population (Trial 1) n = Number in intent-to-treat population. Treatment n Trough FEV 1 (mL) at Day 169 Difference from Placebo (95% CI) n = 280 INCRUSE ELLIPTA n = 418 115 Serial spirometric evaluations throughout the 24-hour dosing interval were performed in a subset of subjects (n = 54, umeclidinium 62.5 mcg; n = 36, placebo) at Days 1, 84, and 168 in Trial 1, and for all patients at Days 1 and 84 in Trial 2. Results from Trial 1 at Day 1 and Day 168 are shown in Figure 3. Figure 3. Least Squares (LS) Mean Change from Baseline in FEV 1 (mL) over Time (0-24 h) on Days 1 and 168 (Trial 1 Subset Population) Day 1 Day 168 In Trial 1, the mean peak FEV 1 (over the first 6 hours relative to baseline) at Day 1 and at Day 168 for the group receiving umeclidinium 62.5 mcg compared with placebo was 126 and 130 mL, respectively. Health-Related Quality of Life Health-related quality of life was measured using St.

George’s Respiratory Questionnaire (SGRQ). Umeclidinium demonstrated an improvement in mean SGRQ total score compared with placebo treatment at Day 168: -4.69 (95% CI: -7.07,-2.31). The proportion of patients with a clinically meaningful decrease (defined as a decrease of at least 4 units from baseline) at Week 24 was greater for INCRUSE ELLIPTA 62.5 mcg (42%; 172/410) compared with placebo (31%; 86/274). Figure 3. Least Squares (LS) Mean Change from Baseline in FEV1 (mL) over Time (0-24 h) on Days 1 and 168 (Trial 1 Subset Population), Day 1 Figure 3. Least Squares (LS) Mean Change from Baseline in FEV1 (mL) over Time (0-24 h) on Days 1 and 168 (Trial 1 Subset Population), Day 168

Maintenance Treatment: Combination with an

ICS/LABA Trials Lung Function The efficacy of INCRUSE ELLIPTA in combination with an ICS/LABA was evaluated in 4 randomized, double-blind, parallel-group trials in subjects with COPD. These trials, all of similar study design, were of 12-weeks’ treatment duration. Subjects were randomized to INCRUSE ELLIPTA 62.5 mcg + ICS/LABA or placebo + ICS/LABA. Entry criteria for subjects enrolled in these trials were similar to those described above in Section 14.2. The primary endpoint for these trials was change from baseline in trough (predose) FEV 1 at Day 85 (defined as the mean of the FEV 1 values obtained at 23 and 24 hours after the previous dose on Day 84). Baseline FEV 1 was measured while subjects were on background ICS/LABA. Combination with Fluticasone Furoate + Vilanterol Trial 4 (NCT01957163) and Trial 5 (NCT02119286) randomized subjects to INCRUSE ELLIPTA 62.5 mcg + FF/VI 100 mcg/25 mcg administered once daily or placebo + FF/VI 100 mcg/25 mcg administered once daily. Trial population demographics and results for Trials 4 and 5 were similar; therefore, only Trial 4 results are presented below.

Subjects in Trial 4 across all treatment arms had a mean age of 64 years and an average smoking history of 50 pack-years, with 42% identified as current smokers. At screening, the mean postbronchodilator percent predicted FEV 1 was 45% (range: 13% to 76%), the mean postbronchodilator FEV 1 /FVC ratio was 0.48 (range: 0.22 to 0.70), and the mean percent reversibility was 14% (range: -20% to 71%). The majority of subjects (85%) reported not having a COPD exacerbation in the prior 12 months. The primary endpoint was change from baseline in trough (predose) FEV 1 at Day 85 (defined as the mean of the FEV 1 values obtained at 23 and 24 hours after the previous dose on Day 84) compared with placebo (INCRUSE ELLIPTA + FF/VI vs. placebo + FF/VI). INCRUSE ELLIPTA + FF/VI demonstrated a larger mean change from baseline in trough (predose) FEV 1 relative to placebo + FF/VI ( Table 3 ). Table 3. Least Squares Mean Change from Baseline in Trough FEV 1 (mL) at Day 85 in the Intent-to-Treat Population (Trial 4) FF/VI = fluticasone furoate/vilanterol. n = Number in intent-to-treat population.

Treatment n Trough FEV 1 (mL) at Day 85 Difference from Placebo + FF/VI (95% CI) n = 206 INCRUSE ELLIPTA + FF/VI n = 206 124 Combination with Fluticasone Propionate + Salmeterol Trial 6 (NCT01772134) and Trial 7 (NCT01772147) randomized subjects to INCRUSE ELLIPTA 62.5 mcg + FP/SAL 250 mcg/50 mcg or placebo + FP/SAL 250 mcg/50 mcg. The treatments with INCRUSE ELLIPTA and placebo were administered once daily, while the FP/SAL treatment was administered twice daily. Trial population demographics and results for Trials 6 and 7 were similar; therefore, only Trial 6 results are presented below.

Subjects in Trial 6 across all treatment arms had a mean age of 63 years and an average smoking history of 50 pack-years, with 54% identified as current smokers. At screening, the mean postbronchodilator percent predicted FEV 1 was 47% (range: 12% to 70%), the mean postbronchodilator FEV 1 /FVC ratio was 0.47 (range: 0.22 to 0.69), and the mean percent reversibility was 16% (range: -36% to 79%). The majority of subjects (79%) reported not having a COPD exacerbation in the prior 12 months. The primary endpoint was change from baseline in trough (predose) FEV 1 at Day 85 (defined as the mean of the FEV 1 values obtained at 23 and 24 hours after the previous dose on Day 84) compared with placebo (INCRUSE ELLIPTA + FP/SAL vs. placebo + FP/SAL). INCRUSE ELLIPTA + FP/SAL demonstrated a larger mean change from baseline in trough (predose) FEV 1 relative to placebo + FP/SAL ( Table 4 ). Table 4. Least Squares Mean Change from Baseline in Trough FEV 1 (mL) at Day 85 in the Intent-to-Treat Population (Trial 6) FP/SAL = fluticasone propionate/salmeterol. n = Number in intent-to-treat population.

Treatment n Trough FEV 1 (mL) at Day 85 Difference from Placebo + FP/SAL (95% CI) n = 205 INCRUSE ELLIPTA+FP/SAL n = 204 147 Exacerbations In Trial 8 (NCT02164513), a total of 10,355 subjects with COPD with a history of 1 or more moderate or severe exacerbations in the prior 12 months were randomized (2:2:1) to receive fluticasone furoate/umeclidinium/vilanterol 100 mcg/62.5 mcg/25 mcg (n = 4,151), fluticasone furoate/vilanterol 100 mcg/25 mcg (n = 4,133), or umeclidinium/vilanterol 62.5 mcg/25 mcg (n = 2,070) administered once daily in a 12-month trial. The population demographics across all treatments were: mean age of 65 years, 77% white, 66% male, and an average smoking history of 46.6 pack-years, with 35% identified as current smokers. At trial entry, the most common COPD medications were ICS + anticholinergic + LABA (34%), ICS + LABA (26%), anticholinergic + LABA (8%), and anticholinergic (7%). The mean postbronchodilator percent predicted FEV 1 was 46% (standard deviation: 15%), the mean postbronchodilator FEV 1 /FVC ratio was 0.47 (standard deviation: 0.12), and the mean percent reversibility was 10% (range: -59% to 125%). The primary endpoint was annual rate of on-treatment moderate and severe exacerbations in subjects treated with fluticasone furoate/umeclidinium/vilanterol compared with the fixed-dose combinations of fluticasone furoate/vilanterol and umeclidinium/vilanterol.

Exacerbations were defined as worsening of 2 or more major symptoms (dyspnea, sputum volume, and sputum purulence) or worsening of any 1 major symptom together with any 1 of the following minor symptoms: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, and increased cough or wheeze for at least 2 consecutive days. Exacerbations were considered to be of moderate severity if treatment with systemic corticosteroids and/or antibiotics was required and were considered to be severe if resulted in hospitalization or death. Evidence of efficacy for INCRUSE ELLIPTA on COPD exacerbations was established by the efficacy of the umeclidinium component of fluticasone furoate/umeclidinium/vilanterol in Trial 8. Treatment with fluticasone furoate/umeclidinium/vilanterol statistically significantly reduced the on-treatment annual rate of moderate/severe exacerbations by 15% compared with fluticasone furoate/vilanterol ( Table 5 ). A reduction in risk of on-treatment moderate/severe exacerbation (as measured by time to first) was also observed for the same comparison.

Table 5. Moderate and Severe Chronic Obstructive Pulmonary Disease Exacerbations (Trial 8) FF/UMEC/VI = Fluticasone furoate/umeclidinium/vilanterol 100 mcg/62.5 mcg/25 mcg, FF/VI = Fluticasone furoate/vilanterol 100 mcg/25 mcg, UMEC/VI = Umeclidinium/vilanterol 62.5 mcg/25 mcg. a On-treatment analyses excluded exacerbation data collected after discontinuation of study treatment. Treatment n Mean Annual Rate (exacerbations/year) FF/UMEC/VI Rate Ratio vs. Comparator (95% CI) % Reduction in Exacerbation Rate (95% CI) P Value FF/UMEC/VI 4,145 0.91 FF/VI 4,133 1.07 0.85 15 P <0.001 UMEC/VI 2,069 1.21 0.75 25 P <0.001

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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