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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014