Safety and Tolerability of QVA149 Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00558285

Purpose

An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: placebo Drug: QVA149 Drug: indacaterol	Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Indacaterol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Determine the Effect of QVA149 and Indacaterol on Mean 24-Hours Heart Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by Novartis:

Primary Outcome Measures:

To assess the effect of 14 days treatment with QVA149 600µg/100µg, QVA 300µg/100µg, QVA149 150µg/100µg on change in mean 24h heart rate compared to placebo delivered by a Single Dose Dry Powder Inhaler (SDDPI

Secondary Outcome Measures:

Change in mean 24h heart rate after 1 & 14 days (D) treatment with QVA v. QAB (also QVA v placebo at 1D). Change in QTc on D 1,7, 14. 24 h Holter assessments on D1, D14. QVA v. placebo & QAB for FEV1 and FVC at all timepoints.

Estimated Enrollment:	250
Study Start Date:	November 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator QVA149 600μg/100μg	Drug: QVA149
2: Active Comparator QVA149 300μg/100μg	Drug: QVA149
3: Active Comparator QVA149 150μg/100μg	Drug: QVA149
4: Active Comparator Indacaterol 300μg	Drug: indacaterol
5: Placebo Comparator placebo	Drug: placebo

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Consented male or female adults aged ≥40 years
Moderate to severe stable COPD according to the GOLD Guidelines (2006)
Patients who have smoking history of at least 10 pack years
Patients with a post-bronchodilator FEV1 ≥30% and <80% of the predicted normal and post-bronchodilator FEV1/FVC <0.70 and Visit 1 and Visit 3

Exclusion Criteria:

Pregnant or nursing (lactating) women
Patients requiring long term oxygen therapy (> 15 hr a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency room for a COPD exacerbation in the 6 weeks prior to screening (Visit 1) or during the screening period
Patients who had a respiratory Tract Infection within 6 weeks of Visit 1 or at screening
Concomitant pulmonary disease, pulmonary TB (unless chest x-ray confirms no longer active)
Any history of asthma
Patients who have clinically relevant lab abnormalities / conditions such as (but not limited to) long term prednisone therapy, unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding stable atrial fibrillation [AF]), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
Patients with a history of cardiac failure, life threatening arrhythmias (screening Holter) and acute ischemic changes (screening ECG)
Patients with a history of long QT syndrome or whose QTc (Fridericia method) interval measured at screening (Visit 1) is prolonged (>450 ms for males or >470 for females)
History of malignancy of any organ system, treated or untreated within the past 5 years
Uncontrolled Type I / Type II Diabetes or blood glucose outside N or HbA1c >8.0% of total hemoglobin measured at Visit 1 Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558285

Show 42 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharma AG

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQVA149A2203
Study First Received:	November 12, 2007
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00558285
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines; Turkey: Ministry of Health

Keywords provided by Novartis:

COPD
Chronic Obstructive Pulmonary Disease
Indacaterol
QVA149

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009