Huntington Beach, California 92647

  • Chronic Obstructive Pulmonary Disease

Purpose:

The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.


Criteria:

Inclusion Criteria: - Male or female adults aged ≥40 yrs - Smoking history of at least 10 pack years - Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015) - Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70% - Modified Medical Research Council questionnaire grade of 2 or higher Exclusion Criteria: - Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 - Patients with concomitant pulmonary disease - Patients with a history of asthma - Any patient with lung cancer or a history of lung cancer - Patients with a history of certain cardiovascular co-morbid conditions - Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency - Patients in the active phase of a supervised pulmonary rehabilitation program - Patients contraindicated for inhaled anticholinergic agents and β2 agonists - Other protocol-defined inclusion/exclusion criteria may apply


Study is Available At:


Original ID:

CQVA149A2349


NCT ID:

NCT02487446


Secondary ID:


Study Acronym:


Brief Title:

Efficacy and Safety Study of QVA149 in COPD Patients


Official Title:

A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, 2-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

357


Enrollment Type:

Actual


Study Dates

Start Date:July 28, 2015
Completion Date:September 12, 2016
Completion Type:Actual
Primary Completion Date:September 12, 2016
Primary Completion Type:Actual
Verification Date:November 2017
Last Changed Date:November 30, 2017
First Received Date:June 29, 2015
First Results Date:September 12, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
Time Frame:baseline, 0 to 24 hours post-dose at week 12
Safety Issues:False
Description:FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline in
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
Time Frame:baseline, 0 to 24 hours post-dose at week 12
Safety Issues:False
Description:FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline in
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)
Time Frame:baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12
Safety Issues:False
Description:FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose for each treatment
Outcome Type:Secondary Outcome
Measure:Change From Baseline in FEV1 AUC 12-24h
Time Frame:baseline, 12 hours to 24 hours post-dose at week 12
Safety Issues:False
Description:FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 12-24h).
Outcome Type:Secondary Outcome
Measure:Change From Baseline in FEV1 AUC 0-12h
Time Frame:baseline, 0 to 12 hours post-dose at week 12
Safety Issues:False
Description:FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 0-12h).
Outcome Type:Secondary Outcome
Measure:Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
Time Frame:baseline, 12 weeks
Safety Issues:False
Description:FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 4 hour intervals FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-1
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)
Time Frame:baseline, 15 minutes and 45 minutes pre morning dose at week 12
Safety Issues:False
Description:FEV1 was measured with spirometry conducted according to internationally accepted standards. Pre-dose trough FEV1 was defined as the average of measurements made 15 minutes and 45 minutes pre morning dose for each treatment.
Outcome Type:Secondary Outcome
Measure:QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Time Frame:Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15mi
Safety Issues:False
Description:FEV1 was measured with spirometry conducted according to internationally accepted standards.
Outcome Type:Secondary Outcome
Measure:QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Time Frame:Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15mi
Safety Issues:False
Description:FEV1 was measured with spirometry conducted according to internationally accepted standards.

Study Interventions

Intervention Type:Drug
Name:QVA149
Description:QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)
Arm Name:First QVA149, then Umeclidinium/vilanterol
Other Name:Indecaterol maleate/glycopyrronium bromide
Intervention Type:Drug
Name:Umeclidinium/vilanterol
Description:Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Arm Name:First QVA149, then Umeclidinium/vilanterol
Other Name:ELLIPTA®
Intervention Type:Drug
Name:Placebo (umeclidinium/vilanterol)
Description:Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Arm Name:First QVA149, then Umeclidinium/vilanterol
Intervention Type:Drug
Name:Placebo (QVA149)
Description:Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
Arm Name:First QVA149, then Umeclidinium/vilanterol

Study Arms

Study Arm Type:Experimental
Arm Name:First QVA149, then Umeclidinium/vilanterol
Description:Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
Study Arm Type:Experimental
Arm Name:First Umeclidinium/vilanterol, then QVA149
Description:Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.