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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00098228
First Posted: December 6, 2004
Last Update Posted: October 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098228


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

ClinicalTrials.gov Identifier: NCT00098228     History of Changes
Other Study ID Numbers: CQAB149B2205
First Submitted: December 3, 2004
First Posted: December 6, 2004
Last Update Posted: October 25, 2011
Last Verified: October 2011

Keywords provided by Novartis:
COPD, adults, QAB149

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