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

October 24, 2011 updated by: Novartis Pharmaceuticals

Dose-Ranging Study in Patients With COPD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

686

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0012
        • UAB Pulmonary Research
      • Mobile, Alabama, United States, 36607
        • Diagnostic & Medical Clinic
      • Mobile, Alabama, United States, 36688
        • The University of South Alabama Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates
    • California
      • Downey, California, United States, 90242
        • USC Rancho Amigos Medical Center
      • Encinitas, California, United States, 92024
        • Radiant Research
      • Los Angeles, California, United States, 90025
        • Allergy Research Foundation , Inc
      • Los Angeles, California, United States, 90095
        • David Geffin UCLA School of Medicine
      • Mission Viejo, California, United States, 92691
        • Southern California Research
      • Palmdale, California, United States, 93551
        • California Allergy & Asthma Medical Group
      • San Diego, California, United States, 921120
        • Allergy Associates Medical Group, Inc
      • San Jose, California, United States, 95117-1780
        • Allergy & Asthma Associates of Santa Clara Research Center
      • Stockton, California, United States, 95207
        • Bensch Clinical Research Associates
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Rocky Mountain Center for Clinical Research
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Physician's Research Center
    • Florida
      • Miami, Florida, United States, 33101
        • University of Miami School of Medicine
      • Pensacola, Florida, United States, 32503
        • Crescent Clinical Research
      • Pensacola, Florida, United States, 32504
        • Cordova Medical Center
      • Tampa, Florida, United States, 33613
        • USF Asthma, Allergy & Immunology, Clinical Research Unit
    • Georgia
      • Augusta, Georgia, United States, 30901
        • University Medical Associates, LLP
      • Austell, Georgia, United States, 30106
        • Radiant Research - Atlanta West
    • Illinois
      • Normal, Illinois, United States, 61761
        • Sneeze, Wheeze & Itch Associates, LLC
      • River Forest, Illinois, United States, 60305
        • Asthma and Allergy Center of Chicago S.C.
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • New Orleans Center for Clinical Research
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • St. Elizabeth's Medical Center
      • Tauton, Massachusetts, United States, 02780
        • Center for Clinical Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Ann Arbor, Michigan, United States, 48106-0525
        • ClinSite, Inc.
      • Livonia, Michigan, United States, 48152
        • Pulmonary Respiratory Institute of Southeast Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
      • Minneapolis, Minnesota, United States, 55407
        • Minnesota Lung Center
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • The Clinical Research Center
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creigton University
      • Omaha, Nebraska, United States, 68198
        • Univ. of Nebraska Medical Center--Pulmonary Research
    • New Hampshire
      • North Dartmouth, New Hampshire, United States, 02747
        • New England Clinical Research
    • New Jersey
      • Skillman, New Jersey, United States, 08558
        • Princeton Center for Clinical Research
      • Springfield, New Jersey, United States, 07081
        • Pulmonary & Allergy Associates
    • New York
      • Rochester, New York, United States, 14518
        • AAIR Reseach Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of Noth Carolina--Pulmonary Division
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research
      • Winston Salem, North Carolina, United States, 27157
        • Cloverdale Research Facility
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Allergy and Asthma Clinic
      • Oklahoma City, Oklahoma, United States, 73104
        • VA Medical Center
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultants Inc.
    • Oregon
      • Eugene, Oregon, United States, 97404
        • River Road Medical Group
      • Portland, Oregon, United States, 97213
        • Allergy Associates Research Center
    • South Carolina
      • Charleston, South Carolina, United States, 29406-7108
        • Low Country Lung and Critical Care
      • Simpsonville, South Carolina, United States, 29681
        • Upstate Pharmaceutical Research
    • Texas
      • Dallas, Texas, United States, 75231
        • Asthma & Allergy Res. Associates
      • New Baunfels, Texas, United States, 78130
        • Central Texas Health Research
      • San Antonio, Texas, United States, 78229
        • Sylvana Research
      • Tyler, Texas, United States, 75702
        • Trinity Clinic Office of Research Admin.
    • Washington
      • Bellingham, Washington, United States, 98226
        • Madrona Medical Group
      • Tacoma, Washington, United States, 98405
        • Pulmonary Consultants, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Other serious disease
  • Allergy to QAB149
  • Respiratory tract infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pulmonary function measured between 22 and 24 hours after dosing on Day 1

Secondary Outcome Measures

Outcome Measure
Pulmonary function measured on days 1 and 7 at various intervals after dosing
Safety measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Novartis East Hanover, 862-778-8300

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

December 3, 2004

First Submitted That Met QC Criteria

December 3, 2004

First Posted (Estimate)

December 6, 2004

Study Record Updates

Last Update Posted (Estimate)

October 25, 2011

Last Update Submitted That Met QC Criteria

October 24, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CQAB149B2205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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