Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT ID: NCT01068613
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2010-01-31
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide and Placebo in Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD) Patients.
NCT00568503
Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium
NCT00501852
Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation
NCT01610037
Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD
NCT02603393
Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations
NCT01120691
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
QAX028 high dose
QAX028
QAX028 60 mcg via inhalation device
QAX028 low dose
QAX028
QAX028 20 mcg via inhalation device
Tiotropium
Tiotropium
Tiotropium via inhalation device
Placebo
Placebo
Placebo to QAX028 via inhalation device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
QAX028
QAX028 60 mcg via inhalation device
QAX028
QAX028 20 mcg via inhalation device
Tiotropium
Tiotropium via inhalation device
Placebo
Placebo to QAX028 via inhalation device
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Post-bronchodilator 30%≤FEV1\<80% of predicted normal and ost-bronchodilator FEV1/FVC \<0.7
* Smoking history of at least 10 pack years
Exclusion Criteria
* Exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing
* Lung reduction surgery
* Respiratory tract infection in the 6 weeks prior to screening
* Significant cardiac history
* History of asthma with onset of symptoms prior to age 40 years
* Active use of certain COPD medications, beta blockers
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Advanced Clinical Research Institute, 1211 W. La Palma Ave
Anaheim, California, United States
Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive
Normal, Illinois, United States
Spartanburg Medical Research, 485 Simuel Road
Spartanburg, South Carolina, United States
New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway
Knoxville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CQAX028A2201 from the Novartis Clinical Trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CQAX028A2201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.