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Efficacy and Safety Study of QVA149 in COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02487446
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: QVA149 Drug: Umeclidinium/vilanterol Drug: Placebo (umeclidinium/vilanterol) Drug: Placebo (QVA149) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 With Moderate to Severe Airflow Limitation
Actual Study Start Date : July 28, 2015
Actual Primary Completion Date : September 12, 2016
Actual Study Completion Date : September 12, 2016


Arm Intervention/treatment
Experimental: First QVA149, then Umeclidinium/vilanterol
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.
Drug: QVA149
QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)
Other Name: Indecaterol maleate/glycopyrronium bromide

Drug: Umeclidinium/vilanterol
Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Other Name: ELLIPTA®

Drug: Placebo (umeclidinium/vilanterol)
Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Drug: Placebo (QVA149)
Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Experimental: First Umeclidinium/vilanterol, then QVA149
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.
Drug: QVA149
QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)
Other Name: Indecaterol maleate/glycopyrronium bromide

Drug: Umeclidinium/vilanterol
Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Other Name: ELLIPTA®

Drug: Placebo (umeclidinium/vilanterol)
Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Drug: Placebo (QVA149)
Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI




Primary Outcome Measures :
  1. 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 ]
    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 indicates improvement.


Secondary Outcome Measures :
  1. 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 ]
    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 indicates improvement.

  2. 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 ]
    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

  3. Change From Baseline in FEV1 AUC 12-24h [ Time Frame: baseline, 12 hours to 24 hours post-dose at week 12 ]
    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).

  4. Change From Baseline in FEV1 AUC 0-12h [ Time Frame: baseline, 0 to 12 hours post-dose at week 12 ]
    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).

  5. 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 ]
    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 12-16h, AUC 16-20h and AUC 20-24h.

  6. 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 ]
    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.

  7. 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, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min) ]
    FEV1 was measured with spirometry conducted according to internationally accepted standards.

  8. 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, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min) ]
    FEV1 was measured with spirometry conducted according to internationally accepted standards.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487446


Locations
Show Show 58 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02487446    
Other Study ID Numbers: CQVA149A2349
First Posted: July 1, 2015    Key Record Dates
Results First Posted: December 26, 2017
Last Update Posted: December 26, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic Obstructive Pulmonary Disease (COPD)
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Glycopyrrolate
Bromides
Anticonvulsants
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs