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Efficacy and Safety Study of QVA149 in COPD Patients

NCT ID: NCT02487446

Last Updated: 2017-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-28

Study Completion Date

2016-09-12

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)

Umeclidinium/vilanterol

Intervention Type DRUG

Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Placebo (umeclidinium/vilanterol)

Intervention Type DRUG

Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Placebo (QVA149)

Intervention Type DRUG

Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI

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.

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)

Umeclidinium/vilanterol

Intervention Type DRUG

Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Placebo (umeclidinium/vilanterol)

Intervention Type DRUG

Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Placebo (QVA149)

Intervention Type DRUG

Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Interventions

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QVA149

QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)

Intervention Type DRUG

Umeclidinium/vilanterol

Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Intervention Type DRUG

Placebo (umeclidinium/vilanterol)

Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Intervention Type DRUG

Placebo (QVA149)

Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Intervention Type DRUG

Other Intervention Names

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Indecaterol maleate/glycopyrronium bromide ELLIPTA®

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Andalusia, Alabama, United States

Site Status

Novartis Investigative Site

Anniston, Alabama, United States

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Novartis Investigative Site

Jasper, Alabama, United States

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Novartis Investigative Site

Multiple Locations, Alabama, United States

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Novartis Investigative Site

Multiple Locations, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Fayetteville, Arkansas, United States

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Huntington Beach, California, United States

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Rancho Mirage, California, United States

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Colorado Springs, Colorado, United States

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Altamonte Springs, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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Pensacola, Florida, United States

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Pensacola, Florida, United States

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Port Orange, Florida, United States

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Conyers, Georgia, United States

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Duluth, Georgia, United States

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Meridian, Idaho, United States

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New Orleans, Louisiana, United States

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Slidell, Louisiana, United States

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Sunset, Louisiana, United States

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Columbia, Maryland, United States

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Edina, Minnesota, United States

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Fridley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Plymouth, Minnesota, United States

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Henderson, Nevada, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Cornelius, North Carolina, United States

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Gastonia, North Carolina, United States

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Hickory, North Carolina, United States

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High Point, North Carolina, United States

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Huntersville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Dublin, Ohio, United States

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Marion, Ohio, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Tipton, Pennsylvania, United States

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Carrollton, Texas, United States

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Channelview, Texas, United States

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Fort Worth, Texas, United States

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Lampasas, Texas, United States

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McKinney, Texas, United States

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New Braunfels, Texas, United States

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Salt Lake City, Utah, United States

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Novartis Investigative Site

Newport News, Virginia, United States

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Novartis Investigative Site

Tacoma, Washington, United States

Site Status

Countries

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United States

References

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Kerwin E, Ferguson GT, Sanjar S, Goodin T, Yadao A, Fogel R, Maitra S, Sen B, Ayers T, Banerji D. Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies. Lung. 2017 Dec;195(6):739-747. doi: 10.1007/s00408-017-0055-9. Epub 2017 Oct 9.

Reference Type DERIVED
PMID: 28993871 (View on PubMed)

Other Identifiers

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CQVA149A2349

Identifier Type: -

Identifier Source: org_study_id