Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00098228
First received: December 3, 2004
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

The trial is designed to identify an appropriate dose of QAB149 for delivery via a multiple dose inhaler for use in the COPD Phase III program.


Condition Intervention Phase
COPD
Drug: QAB149
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dose-Ranging Study in Patients With COPD

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pulmonary function measured between 22 and 24 hours after dosing on Day 1

Secondary Outcome Measures:
  • Pulmonary function measured on days 1 and 7 at various intervals after dosing
  • Safety measurements

Enrollment: 686
Study Start Date: July 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of COPD
  • Age 40-75 years
  • Smoking history

Exclusion Criteria:

  • Other serious disease
  • Allergy to QAB149
  • Respiratory tract infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098228

  Show 54 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Investigator: Novartis East Hanover 862-778-8300
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00098228     History of Changes
Other Study ID Numbers: CQAB149B2205
Study First Received: December 3, 2004
Last Updated: October 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
COPD, adults, QAB149

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014