Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00570778 | Completed Phase 2 Results

• 1 other identifier: CQVA149A2204
• Study Type: interventional
• Target: 154
• Locations: 5 countries
• Sites: 22

Brief Summary

This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7

  Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.

  Baseline, Day 7

Secondary Outcomes (2)

• Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7

  Day 7

• Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events

  47 days

Study Arms (4)

indacaterol/glycopyrrolate 300/50 μg

EXPERIMENTAL

One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.

Drug: indacaterol/glycopyrrolate

indacaterol 600 μg

ACTIVE COMPARATOR

Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

Drug: indacaterol

indacaterol 300 μg

ACTIVE COMPARATOR

One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.

Drug: indacaterol

placebo

PLACEBO COMPARATOR

Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

Drug: placebo

Interventions

indacaterol/glycopyrrolate DRUG

Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.

Also known as: QVA149

indacaterol/glycopyrrolate 300/50 μg

indacaterol DRUG

Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

Also known as: QAB149

indacaterol 300 μg; indacaterol 600 μg

placebo DRUG

Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

placebo

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 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
• Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
• Patients who have smoking history of at least 10 pack years.
• Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and \< 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) \<0.70.

You may not qualify if:

• Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
• Patients requiring long term oxygen therapy (\> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
• Patients who have had a respiratory tract infection within 6 weeks prior to screening.
• Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
• Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 400/mm3.
• Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
• Patients with uncontrolled Type I and Type II diabetes.
• History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
• Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
• Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (\>450 ms for males or \>470 ms for females).
• Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (22)

Novartis Investigator Site

St Louis, Missouri, United States

Location

Novartis Investigator Site

Charlotte, North Carolina, United States

Location

Novartis Investigator site

Raleigh, North Carolina, United States

Location

Novartis Investigator Site

Antwerp, Belgium

Location

Novartis Investigator Site

Ghent, Belgium

Location

Novartis Investigator Site

Jambes, Belgium

Location

Novartis Investigator Site

Sankt Vith, Belgium

Location

Novartis Investigator Site

Moncton, Canada

Location

Novartis Investigator Site

Montreal, Canada

Location

Novartis Investigator site

Toronto, Canada

Location

Novartis Investigator Site

Bad Wörishofen, Germany

Location

Novartis Investigator Site

Berlin, Germany

Location

Novartis Investigator Site

Frankfurt, Germany

Location

Novartis Investigator Site

Mainz, Germany

Location

Novartis Investigator Site

Rüdersdorf, Germany

Location

Novartis Investigator Site

Wiesbaden, Germany

Location

Novartis Investigator Site

Almelo, Netherlands

Location

Novartis Investigator Site

Breda, Netherlands

Location

Novartis Investigator site

Eindhoven, Netherlands

Location

Novartis investigator site

Heerlen, Netherlands

Location

Novartis Investigator Site

Nijmegen, Netherlands

Location

Novartis Investigator Site

Veldhoven, Netherlands

Location

Related Publications (1)

• van Noord JA, Buhl R, Laforce C, Martin C, Jones F, Dolker M, Overend T. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax. 2010 Dec;65(12):1086-91. doi: 10.1136/thx.2010.139113. Epub 2010 Oct 26.

  PMID: 20978028 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Glycopyrrolate; indacaterol-glycopyrronium combination

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 CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 11, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 26, 2018
• Results First Posted: February 28, 2013

Record last verified: 2018-06

Locations

NL (6); US (3); BE (4); DE (6); CA (3)