Clinical trial NCT00570778: Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Double-blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-11
Enrollment: 154
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
2. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
3. Patients who have smoking history of at least 10 pack years.
4. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. Patients who have had a respiratory tract infection within 6 weeks prior to screening.
4. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
5. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 400/mm3.
6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
7. Patients with uncontrolled Type I and Type II diabetes.
8. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
9. Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
10. 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).
11. 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
timeFrame: Baseline, Day 7
Secondary outcomes:
measure: Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7
timeFrame: Day 7
measure: Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
timeFrame: 47 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Charlotte
country: United States
facility: Novartis Investigator Site
state: North Carolina
city: Raleigh
country: United States
facility: Novartis Investigator site
state: North Carolina
city: Antwerpen
country: Belgium
facility: Novartis Investigator Site
city: Gent
country: Belgium
facility: Novartis Investigator Site
city: Jambes
country: Belgium
facility: Novartis Investigator Site
city: Saint Vith
country: Belgium
facility: Novartis Investigator Site
city: Moncton
country: Canada
facility: Novartis Investigator Site
city: Montreal
country: Canada
facility: Novartis Investigator Site
city: Toronto
country: Canada
facility: Novartis Investigator site
city: Bad Worishofen
country: Germany
facility: Novartis Investigator Site
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Frankfurt
country: Germany
facility: Novartis Investigator Site
city: Mainz
country: Germany
facility: Novartis Investigator Site
city: Rudersdorf
country: Germany
facility: Novartis Investigator Site
city: Wiesbaden
country: Germany
facility: Novartis Investigator Site
city: Almelo
country: Netherlands
facility: Novartis Investigator Site
city: Breda
country: Netherlands
facility: Novartis Investigator Site
city: Eindhoven
country: Netherlands
facility: Novartis Investigator site
city: Heerlen
country: Netherlands
facility: Novartis investigator site
city: Nijmegen
country: Netherlands
facility: Novartis Investigator Site
city: Veldhoven
country: Netherlands
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: 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.