Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Randomized, Double-blind, Double-dummy, Three Period Incomplete Cross-over Study to Evaluate the Safety and Efficacy of Multiple Daily Doses of QAX028 as Compared to Tiotropium Bromide (Positive Control) and Placebo in COPD Patients
1 other identifier
interventional
62
1 country
4
Brief Summary
This study will assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 chronic-obstructive-pulmonary-disease
Started Jan 2010
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 12, 2010
CompletedFirst Posted
Study publicly available on registry
February 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedDecember 19, 2020
May 1, 2012
7 months
February 12, 2010
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium
7 days treatment
Secondary Outcomes (5)
Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium
7 days treatment
Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo
7 days treatment
Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients
7 days treatment
Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028
7 days treatment
Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients
7 days treatment
Study Arms (4)
QAX028 high dose
EXPERIMENTALQAX028 low dose
EXPERIMENTALTiotropium
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD according to GOLD guidelines
- Post-bronchodilator 30%≤FEV1\<80% of predicted normal and ost-bronchodilator FEV1/FVC \<0.7
- Smoking history of at least 10 pack years
You may not qualify if:
- Requiring oxygen therapy on a daily basis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Advanced Clinical Research Institute, 1211 W. La Palma Ave
Anaheim, California, CA, United States
Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive
Normal, Illinois, IL61761, United States
Spartanburg Medical Research, 485 Simuel Road
Spartanburg, South Carolina, SC 29303, United States
New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway
Knoxville, Tennessee, TN 37920, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2010
First Posted
February 15, 2010
Study Start
January 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
December 19, 2020
Record last verified: 2012-05