Clinical Trials/NCT02554786

NCT02554786

Completed

Phase 3

A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma

Novartis Pharmaceuticals1 site in 1 country2,216 target enrollmentDecember 29, 2015

ConditionsAsthma

InterventionsIndacaterol acetate/Mometasone furoate Mometasone furoate Salmeterol xinafoate/fluticasone propionate

DrugsIndacaterol acetate/Mometasone furoate Mometasone furoate Salmeterol xinafoate/fluticasone propionate

Overview

Phase: Phase 3
Intervention: Indacaterol acetate/Mometasone furoate
Conditions: Asthma
Sponsor: Novartis Pharmaceuticals
Enrollment: 2216
Locations: 1
Primary Endpoint: Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control

Registry

clinicaltrials.gov

Start Date

December 29, 2015

End Date

June 28, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening)
•Participants who have used medium or high dose inhaled corticosteroids (ICS) or low dose of long acting beta-2 agonist (LABA)/ICS combinations for asthma for at least 3 months and at stable doses for at least 1 month prior to Visit 1
•Participants must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS
•Pre-bronchodilator ≥ 50% Forced expiratory volume in 1 second (FEV1) of \< 85 % of the predicted normal value for the participants after withholding bronchodilators at both Visit 101 and 102, according to American Thoracic Society/European Respiratory Society (ATS/ERS) criteria.
•Withholding period of bronchodilators prior to spirometry: short acting beta-2 agonist (SABA) for ≥ 6 hours and FDC or free combinations of ICS/LABA for ≥ 48 hours, short acting anticholinergics (SAMA) for ≥ 8 hours, xanthines \>=07 days
•A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is allowed at Visit 101 and at Visit
•Spacer devices are permitted for reversibility testing only.
•Participants who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101 All participants must perform a reversibility test at Visit 101
•If reversibility is not demonstrated at Visit 101:
•Reversibility should be repeated once-

Exclusion Criteria

•Participants who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. This includes use of nicotine inhalers such as e-cigarettes at the time of Visit 1
•Participants who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening)
•Participants who have ever required intubation for a severe asthma attack/exacerbation.
•Participants who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study).
•Participants who have had a respiratory tract infection or asthma worsening as determined by the investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit
•Participants may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
•Participants with a history of chronic lung diseases other than asthma, including (but not limited to) Chronic Obstructive Pulmonary Disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
•Participants with severe narcolepsy and/or insomnia.
•Participants who have a clinically significant electrocardiogram (ECG) abnormality at Visit 101 (Start of Run- In epoch) and at any time between Visit 101 and Visit 102 (including unscheduled ECG). ECG evidence of myocardial infarction at Visit 101 (via central reader) should be clinically assessed by the investigator with supportivedocumentation
•Participants with a history of hypersensitivity to lactose, any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof

Arms & Interventions

QMF149 150/160 µg

QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered once daily (o.d) via Concept1 inhaler in the evening.

Intervention: Indacaterol acetate/Mometasone furoate

QMF149 150/320 µg

QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d via Concept1 inhaler in the evening.

Intervention: Indacaterol acetate/Mometasone furoate

MF 400 µg

Mometasone furoate (MF) 400 μg was delivered o.d via Twisthaler® in the evening

Intervention: Mometasone furoate

Salmeterol /fluticasone 50/500 μg

Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.

Intervention: Salmeterol xinafoate/fluticasone propionate

MF 800 μg

MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.

Intervention: Mometasone furoate

Outcomes

Primary Outcomes

Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26

Time Frame: 26 weeks

Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.

Secondary Outcomes

Annual Rate of Asthma Exacerbations by Exacerbation Category(Up to Week 52)
Duration in Days of Asthma Exacerbations by Exacerbation Category(Up to Week 52)
Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52(Weeks 4, 12, 26 and 52)
Post Dose FEV1 (5 Minutes-1 Hour)(Up to Week 52 (Day 364))
Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)(Up to Week 52 (Day 365))
Time to First Asthma Exacerbation by Exacerbation Category(Up to Week 52)
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)(Approximately up to 56 weeks)
Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category(Up to Week 52)
Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations(Up to Week 52)
Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations(Up to Week 52)
Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes(Up to Week 52)
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment(Up to Weeks 26 and 52)
Change From Baseline in Percentage of Asthma Symptoms Free Days(Up to Week 52)
Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52(Weeks 26 (Day 183) and 52 (Day 364))
Change From Baseline in Percentage of Rescue Medication Free Days(Up to Weeks 26 and 52)
Trough FEV1 Measured After 26 Weeks of Treatment(Week 26)
Trough Forced Vital Capacity (FVC)(Up to Week 52 (Day 365))
Change Form Baseline in Percentage of Days With no Daytime Symptoms(Up to Week 52)
Change From Baseline in Percentage of Nights With no Night-time Awakenings(Up to Week 52)
Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations(Up to Week 52)
Asthma Quality of Life Questionnaire (AQLQ)(Up to Week 52 (Day 364))
Trough FEV1 at Week 52(Week 52)
Pre-dose FEV1 at Weeks 4 and 12(Weeks 4 (Day 30) and 12 (Day 86))
Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening(Up to Week 52)
Rescue Medication Usage(Up to Weeks 26 and 52)
Time to First Hospitalization for Asthma Exacerbation(Up to Week 52)