Safety, Tolerability and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide and Placebo in Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD) Patients.
A Partially Blinded, Single-dose, Cross-over Proof of Concept Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide (Positive Control) and Placebo in Mild-to-moderate COPD Patients
1 other identifier
interventional
29
1 country
1
Brief Summary
This will be a single dose Proof-of-Concept study in mild-to-moderate COPD patients. The study will investigate the safety and tolerability of QAX028 as well as the bronchodilatory effects of QAX028 compared to tiotropium and placebo in mild-to-moderate COPD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2007
Shorter than P25 for phase_1
1 active site
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
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 5, 2007
CompletedFirst Posted
Study publicly available on registry
December 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedApril 28, 2011
April 1, 2011
4 months
December 5, 2007
April 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety, tolerability and pharmacodynamics of a single dose of QAX028 compared to tiotropium bromide 18μg and to placebo.
throughout the study
Secondary Outcomes (1)
The forced expiratory volume in 1 second (FEV1)and time profile using a kinetic pharmacodynamic (KPD) model on single doses of QAX028. Pharmacokinetics of inhaled doses of QAX028.
throughout the study
Study Arms (5)
1
ACTIVE COMPARATORQAX028 high dose
2
PLACEBO COMPARATORPlacebo
3
ACTIVE COMPARATORTiotropium bromide
4
ACTIVE COMPARATORQAX028 medium dose
5
ACTIVE COMPARATORQAX028 low dose
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients aged 40-75 years with diagnosis of mild or moderate COPD
- Current or X-smokers with a smoking history of \>10 pack-years.
- Screening ipratropium post-bronchodilation FEV1 at 1 h post-dose will be greater than 50% of the normal predicted FEV1 value.
You may not qualify if:
- Patients who can not comply with the following washout periods for standard
- COPD treatments as follows should be excluded:
- Short-acting bronchodilators
- Long-acting bronchodilators
- Inhaled steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Investigator Site
Birkeroed, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
NOVARTIS
Novartis investigative site
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 5, 2007
First Posted
December 6, 2007
Study Start
October 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
April 28, 2011
Record last verified: 2011-04