Clinical trial NCT00098228: Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Dose-Ranging Study in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Keywords: COPD, adults, QAB149
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-06
Enrollment: 686
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Pulmonary function measured between 22 and 24 hours after dosing on Day 1
Secondary outcomes:
measure: Pulmonary function measured on days 1 and 7 at various intervals after dosing
measure: Safety measurements
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Pulmonary Research
state: Alabama
city: Mobile
country: United States
facility: Diagnostic & Medical Clinic
state: Alabama
city: Mobile
country: United States
facility: The University of South Alabama Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Downey
country: United States
facility: USC Rancho Amigos Medical Center
state: California
city: Encinitas
country: United States
facility: Radiant Research
state: California
city: Los Angeles
country: United States
facility: Allergy Research Foundation , Inc
state: California
city: Los Angeles
country: United States
facility: David Geffin UCLA School of Medicine
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: Palmdale
country: United States
facility: California Allergy & Asthma Medical Group
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group, Inc
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Research Center
state: California
city: Stockton
country: United States
facility: Bensch Clinical Research Associates
state: California
city: Wheat Ridge
country: United States
facility: Rocky Mountain Center for Clinical Research
state: Colorado
city: Hartford
country: United States
facility: Physician's Research Center
state: Connecticut
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Pensacola
country: United States
facility: Crescent Clinical Research
state: Florida
city: Pensacola
country: United States
facility: Cordova Medical Center
state: Florida
city: Tampa
country: United States
facility: USF Asthma, Allergy & Immunology, Clinical Research Unit
state: Florida
city: Augusta
country: United States
facility: University Medical Associates, LLP
state: Georgia
city: Austell
country: United States
facility: Radiant Research - Atlanta West
state: Georgia
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates, LLC
state: Illinois
city: River Forest
country: United States
facility: Asthma and Allergy Center of Chicago S.C.
state: Illinois
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Brighton
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Tauton
country: United States
facility: Center for Clinical Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: ClinSite, Inc.
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Livonia
country: United States
facility: Pulmonary Respiratory Institute of Southeast Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: St. Louis
country: United States
facility: The Clinical Research Center
state: Missouri
city: Omaha
country: United States
facility: Creigton University
state: Nebraska
city: Omaha
country: United States
facility: Univ. of Nebraska Medical Center--Pulmonary Research
state: Nebraska
city: North Dartmouth
country: United States
facility: New England Clinical Research
state: New Hampshire
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Springfield
country: United States
facility: Pulmonary & Allergy Associates
state: New Jersey
city: Rochester
country: United States
facility: AAIR Reseach Center
state: New York
city: Chapel Hill
country: United States
facility: University of Noth Carolina--Pulmonary Division
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Winston Salem
country: United States
facility: Cloverdale Research Facility
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Allergy and Asthma Clinic
state: Oklahoma
city: Oklahoma City
country: United States
facility: VA Medical Center
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants Inc.
state: Oklahoma
city: Eugene
country: United States
facility: River Road Medical Group
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Charleston
country: United States
facility: Low Country Lung and Critical Care
state: South Carolina
city: Simpsonville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Dallas
country: United States
facility: Asthma & Allergy Res. Associates
state: Texas
city: New Baunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research
state: Texas
city: Tyler
country: United States
facility: Trinity Clinic Office of Research Admin.
state: Texas
city: Bellingham
country: United States
facility: Madrona Medical Group
state: Washington
city: Tacoma
country: United States
facility: Pulmonary Consultants, PLLC
state: Washington
Study officials:
affiliation: 862-778-8300
name: Novartis East Hanover
References: