Efficacy and Safety Study of QVA149 in COPD Patients

NCT02487446 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CQVA149A2349
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 58

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h

  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.

  baseline, 0 to 24 hours post-dose at week 12

Secondary Outcomes (8)

• Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h

  baseline, 0 to 24 hours post-dose at week 12

• Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)

  baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12

• Change From Baseline in FEV1 AUC 12-24h

  baseline, 12 hours to 24 hours post-dose at week 12

• Change From Baseline in FEV1 AUC 0-12h

  baseline, 0 to 12 hours post-dose at week 12

• Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h

  baseline, 12 weeks

Study Arms (2)

First QVA149, then Umeclidinium/vilanterol

EXPERIMENTAL

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; Drug: Umeclidinium/vilanterol; Drug: Placebo (umeclidinium/vilanterol); Drug: Placebo (QVA149)

First Umeclidinium/vilanterol, then QVA149

EXPERIMENTAL

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; Drug: Umeclidinium/vilanterol; Drug: Placebo (umeclidinium/vilanterol); Drug: Placebo (QVA149)

Interventions

QVA149 DRUG

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

Also known as: Indecaterol maleate/glycopyrronium bromide

First QVA149, then Umeclidinium/vilanterol; First Umeclidinium/vilanterol, then QVA149

Umeclidinium/vilanterol DRUG

Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Also known as: ELLIPTA®

First QVA149, then Umeclidinium/vilanterol; First Umeclidinium/vilanterol, then QVA149

Placebo (umeclidinium/vilanterol) DRUG

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

First QVA149, then Umeclidinium/vilanterol; First Umeclidinium/vilanterol, then QVA149

Placebo (QVA149) DRUG

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

First QVA149, then Umeclidinium/vilanterol; First Umeclidinium/vilanterol, then QVA149

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (58)

Novartis Investigative Site

Andalusia, Alabama, 36305, United States

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Novartis Investigative Site

Anniston, Alabama, 36207-5710, United States

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Novartis Investigative Site

Jasper, Alabama, 35501, 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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Novartis Investigative Site

Tempe, Arizona, 85283, United States

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Novartis Investigative Site

Tucson, Arizona, 85723, United States

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Novartis Investigative Site

Fayetteville, Arkansas, 72703, United States

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Novartis Investigative Site

Huntington Beach, California, 92647, United States

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Novartis Investigative Site

Rancho Mirage, California, 92270, United States

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Novartis Investigative Site

Colorado Springs, Colorado, 80907, United States

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Novartis Investigative Site

Altamonte Springs, Florida, 32701, United States

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Novartis Investigative Site

DeLand, Florida, 32720, United States

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Novartis Investigative Site

Fort Lauderdale, Florida, 33316-192, United States

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Novartis Investigative Site

Kissimmee, Florida, 34741, United States

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Novartis Investigative Site

Miami, Florida, 33172, United States

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Novartis Investigative Site

Pensacola, Florida, 32503, United States

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Novartis Investigative Site

Pensacola, Florida, 32504, United States

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Novartis Investigative Site

Port Orange, Florida, 32127, United States

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Novartis Investigative Site

Conyers, Georgia, 30094, United States

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Novartis Investigative Site

Duluth, Georgia, 30096, United States

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Novartis Investigative Site

Meridian, Idaho, 83642, United States

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Novartis Investigative Site

New Orleans, Louisiana, 70119, United States

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Novartis Investigative Site

Slidell, Louisiana, 70458, United States

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Novartis Investigative Site

Sunset, Louisiana, 70584, United States

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Novartis Investigative Site

Columbia, Maryland, 21044, United States

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Novartis Investigative Site

Edina, Minnesota, 55435, United States

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Novartis Investigative Site

Fridley, Minnesota, 55432, United States

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Novartis Investigative Site

Minneapolis, Minnesota, 55402, United States

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Novartis Investigative Site

Minneapolis, Minnesota, 55407, United States

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Novartis Investigative Site

Plymouth, Minnesota, 55441, United States

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Novartis Investigative Site

Henderson, Nevada, 89014, United States

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Novartis Investigative Site

New York, New York, 10016, United States

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Novartis Investigative Site

Charlotte, North Carolina, 28207, United States

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Novartis Investigative Site

Cornelius, North Carolina, 28031, United States

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Novartis Investigative Site

Gastonia, North Carolina, 28054, United States

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Novartis Investigative Site

Hickory, North Carolina, 28602, United States

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Novartis Investigative Site

High Point, North Carolina, 27262, United States

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Novartis Investigative Site

Huntersville, North Carolina, 28078, United States

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Novartis Investigative Site

Winston-Salem, North Carolina, 27103, United States

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Novartis Investigative Site

Cincinnati, Ohio, 45242, United States

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Novartis Investigative Site

Columbus, Ohio, 43213, United States

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Novartis Investigative Site

Columbus, Ohio, 43215, United States

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Novartis Investigative Site

Dublin, Ohio, 43016, United States

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Novartis Investigative Site

Marion, Ohio, 43302, United States

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Novartis Investigative Site

Medford, Oregon, 97504, United States

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Novartis Investigative Site

Portland, Oregon, 97213, United States

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Novartis Investigative Site

Philadelphia, Pennsylvania, 19142, United States

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Novartis Investigative Site

Tipton, Pennsylvania, 16684, United States

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Novartis Investigative Site

Carrollton, Texas, 75010, United States

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Novartis Investigative Site

Channelview, Texas, 77530, United States

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Novartis Investigative Site

Fort Worth, Texas, 76109, United States

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Novartis Investigative Site

Lampasas, Texas, 76550, United States

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Novartis Investigative Site

McKinney, Texas, 75069, United States

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Novartis Investigative Site

New Braunfels, Texas, 78130, United States

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Novartis Investigative Site

Salt Lake City, Utah, 84102, United States

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Novartis Investigative Site

Newport News, Virginia, 23606, United States

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Novartis Investigative Site

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• 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.

  PMID: 28993871 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; Glycopyrrolate; GSK573719; vilanterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-1873

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 1, 2015
• Study Start: July 28, 2015
• Primary Completion: September 12, 2016
• Study Completion: September 12, 2016
• Last Updated: December 26, 2017
• Results First Posted: December 26, 2017

Record last verified: 2017-11

Locations

US (58)