Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01529632 | Completed Phase 3 Results

• 2 other identifiers: CQVA149A23262011-006050-91
• Study Type: interventional
• Target: 193
• Locations: 5 countries
• Sites: 26

Brief Summary

The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; COPD; QVA149; QAB149; NVA237; indacaterol; glycopyrronium bromide

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment

  Spirometry was conducted according to internationally accepted standards. Trough FEV1 is defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings measured at day 29, after 28 days of treatment. Mixed model: Trough FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.

  Day 29

Secondary Outcomes (6)

• Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 1

  0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 1

• Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 28

  0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 28

• Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 28 Post-dose

  5 min - 4 hr at Days 1 and 28

• Time Course of Forced Expiratory Volume in One Second (FEV1) (Pre-dose to 4 Hours Post Dose) on Day 28

  -45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28

• Change From Baseline in the Mean Daily, (Daytime and Nighttime Combined) Number of Puffs of Rescue Medication Used Over 28 Days of Treatment

  Baseline and 28 days

Study Arms (2)

QVA149

EXPERIMENTAL

QVA149 plus placebo once daily for 28 days.

Drug: QVA149; Drug: Placebo

QAB149 + NVA237

ACTIVE COMPARATOR

Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.

Drug: NVA237; Drug: QAB149

Interventions

QVA149 DRUG

QVA149 110/50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily

QVA149

NVA237 DRUG

NVA237 50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily

QAB149 + NVA237

QAB149 DRUG

QAB149 150 ug supplied as capsules in blister packs for inhalation via SDDPI , once daily

QAB149 + NVA237

Placebo DRUG

Placebo capsules provided in blister packs for inhalation via SDDPI, once daily

QVA149

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), 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 COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2010)
• Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

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 (26)

Novartis Investigative Site

Feldbach, Austria, 8330, Austria

Location

Novartis Investigative Site

Grieskirchen, Austria, 4710, Austria

Location

Novartis Investigative Site

Linz, Austria, 4020, Austria

Location

Novartis Investigative Site

Wels, Austria, 4600, Austria

Location

Novartis Investigative Site

Aalborg, Denmark, DK-9100, Denmark

Location

Novartis Investigative Site

Hvidovre, Denmark, DK-2650, Denmark

Location

Novartis Investigative Site

Aarhus, DK-8000, Denmark

Location

Novartis Investigative Site

Copenhagen NV, DK-2400, Denmark

Location

Novartis Investigative Site

Odense C, DK-5000, Denmark

Location

Novartis Investigative Site

Almelo, Netherlands, 7609 PP, Netherlands

Location

Novartis Investigative Site

Harderwijk, Netherlands, 3840 AC, Netherlands

Location

Novartis Investigative Site

Heerlen, Netherlands, 6419 PC, Netherlands

Location

Novartis Investigative Site

Eindhoven, 5623 EJ, Netherlands

Location

Novartis Investigative Site

Hengelo, 7555 DL, Netherlands

Location

Novartis Investigative Site

Sittard-Geleen, 6162 BG, Netherlands

Location

Novartis Investigative Site

Tubbergen, 7651 JH, Netherlands

Location

Novartis Investigative Site

Veldhoven, 5504 DB, Netherlands

Location

Novartis Investigative Site

Kløfta, 2040, Norway

Location

Novartis Investigative Site

Kongsvinger, 2212, Norway

Location

Novartis Investigative Site

Skedsmokorset, 2020, Norway

Location

Novartis Investigative Site

Stavanger, 4005, Norway

Location

Novartis Investigative Site

Trondheim, 7006, Norway

Location

Novartis Investigative Site

Gothenburg, 412 63, Sweden

Location

Novartis Investigative Site

Stockholm, 111 57, Sweden

Location

Novartis Investigative Site

Stockholm, S-171 76, Sweden

Location

Novartis Investigative Site

Uddevalla, 451 50, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; Glycopyrrolate; indacaterol

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

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 9, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 12, 2014
• Results First Posted: February 12, 2014

Record last verified: 2014-01

Locations

NL (8); AU (4); DK (5); NO (5); SE (4)