COPDPhase 2NCT00098228
Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing QAB149 in people with COPD, run by Novartis Pharmaceuticals at 54 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- QAB149
- How many people
- 686 participants
- Where
- 54 sitesUnited States
- Study dates
- Jul 2004to Dec 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD
- Age 40-75 years
- Smoking history
Who cannot join
- Other serious disease
- Allergy to QAB149
- Respiratory tract infection
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
ClinSite, Inc.
Ann Arbor, Michigan, 48106-0525
University of Michigan Health System
Ann Arbor, Michigan, 48109
University Medical Associates, LLP
Augusta, Georgia, 30901
Radiant Research - Atlanta West
Austell, Georgia, 30106
Madrona Medical Group
Bellingham, Washington, 98226
UAB Pulmonary Research
Birmingham, Alabama, 35294-0012
St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
University of Noth Carolina--Pulmonary Division
Chapel Hill, North Carolina, 27599
Low Country Lung and Critical Care
Charleston, South Carolina, 29406-7108
Asthma & Allergy Res. Associates
Dallas, Texas, 75231
USC Rancho Amigos Medical Center
Downey, California, 90242
Radiant Research
Encinitas, California, 92024
River Road Medical Group
Eugene, Oregon, 97404
Physician's Research Center
Hartford, Connecticut, 06106
Pulmonary Respiratory Institute of Southeast Michigan
Livonia, Michigan, 48152
Allergy Research Foundation , Inc
Los Angeles, California, 90025
David Geffin UCLA School of Medicine
Los Angeles, California, 90095
University of Miami School of Medicine
Miami, Florida, 33101
Clinical Research Institute
Minneapolis, Minnesota, 55402
Minnesota Lung Center
Minneapolis, Minnesota, 55407
Southern California Research
Mission Viejo, California, 92691
Diagnostic & Medical Clinic
Mobile, Alabama, 36607
The University of South Alabama Medical Center
Mobile, Alabama, 36688
Central Texas Health Research
New Baunfels, Texas, 78130
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70118
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, 61761
New England Clinical Research
North Dartmouth, New Hampshire, 02747
Oklahoma Allergy and Asthma Clinic
Oklahoma City, Oklahoma, 73104
VA Medical Center
Oklahoma City, Oklahoma, 73104
Creigton University
Omaha, Nebraska, 68131
Univ. of Nebraska Medical Center--Pulmonary Research
Omaha, Nebraska, 68198
California Allergy & Asthma Medical Group
Palmdale, California, 93551
Crescent Clinical Research
Pensacola, Florida, 32503
Cordova Medical Center
Pensacola, Florida, 32504
Pulmonary Associates
Phoenix, Arizona, 85006
Allergy Associates Research Center
Portland, Oregon, 97213
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Asthma and Allergy Center of Chicago S.C.
River Forest, Illinois, 60305
AAIR Reseach Center
Rochester, New York, 14518
Sylvana Research
San Antonio, Texas, 78229
Allergy Associates Medical Group, Inc
San Diego, California, 921120
Allergy & Asthma Associates of Santa Clara Research Center
San Jose, California, 95117-1780
Upstate Pharmaceutical Research
Simpsonville, South Carolina, 29681
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
Pulmonary & Allergy Associates
Springfield, New Jersey, 07081
The Clinical Research Center
St Louis, Missouri, 63141
Bensch Clinical Research Associates
Stockton, California, 95207
Pulmonary Consultants, PLLC
Tacoma, Washington, 98405
USF Asthma, Allergy & Immunology, Clinical Research Unit
Tampa, Florida, 33613
Center for Clinical Research
Tauton, Massachusetts, 02780
Healthcare Research Consultants Inc.
Tulsa, Oklahoma, 74135
Trinity Clinic Office of Research Admin.
Tyler, Texas, 75702
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033
Cloverdale Research Facility
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
- Conditions
- COPD
- Being tested
- QAB149
- Keywords
- COPD, adults, QAB149
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAB149Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function measured between 22 and 24 hours after dosing on Day 1
Secondary outcomes (2)
Pulmonary function measured on days 1 and 7 at various intervals after dosing
Safety measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2004 (estimated)
- Study startJul 2004
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis East Hanover, 862-778-8300
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098228
- Sponsor's protocol ID
- CQAB149B2205
- Status last verified
- Oct 2011
- First submitted
- 3 Dec 2004
- Last updated
- 25 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Ranging Study in Patients With COPD
- ClinicalTrials.gov ID
- NCT00098228
- Acronym / sponsor ID
- CQAB149B2205
- Conditions
- COPD
- Keywords
- COPD, adults, QAB149
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 6 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COPD
- Age 40-75 years
- Smoking history
Key exclusion criteria (3 listed)
- Other serious disease
- Allergy to QAB149
- Respiratory tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QAB149 | Drug | – |
Primary outcome
Pulmonary function measured between 22 and 24 hours after dosing on Day 1
2 secondary outcomes
Pulmonary function measured on days 1 and 7 at various intervals after dosing
Safety measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
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The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis East Hanover
862-778-8300
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAB149 in people with COPD, run by Novartis Pharmaceuticals at 54 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function measured between 22 and 24 hours after dosing on Day 1. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2011.