Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Single Dose, Double-blind, Double-dummy, 3 Period Cross-over, Placebo Controlled Clinical Trial to Assess the Reate of Onset of Action of Inhaled Aclidinium Bromide 200µg Compared to Placebo and Tiotropium 18µg in Patients With Chronic Obstructive Pulmonary Disease (COPD).
2 other identifiers
interventional
115
1 country
1
Brief Summary
This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2007
Shorter than P25 for phase_3
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
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 14, 2007
CompletedFirst Posted
Study publicly available on registry
February 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedNovember 17, 2016
November 1, 2016
6 months
February 14, 2007
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FEV1 Percentage Increase
Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes
30 minutes
Secondary Outcomes (1)
Normalised Area FEV1 AUC 0-3h
0-3 hours
Study Arms (3)
Tiotropium
ACTIVE COMPARATOR1 puff, 1 day treatment
Placebo
PLACEBO COMPARATORTiotropium or Aclidinium Placebo, 1 day treatment
Aclidinium bromide
EXPERIMENTAL200 micrograms, once daily, 1 day treatment
Interventions
1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00
Eligibility Criteria
You may qualify if:
- Males and females aged ≥ 40 years
- Current or ex-smokers of ≥ 10 pack-year
- Clinical diagnosis of severe stable COPD
You may not qualify if:
- History or current diagnosis of asthma, allergic rhinitis, or atopy
- Respiratory tract infection or acute COPD exacerbation in the last 6 weeks
- Hospitalised for an acute COPD exacerbation in the last 3 months
- Evidence of contraindicated use of anticholinergic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Respiratory Clinical Trials Ltd
London, W1G 8HU, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Esther Garcia, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2007
First Posted
February 15, 2007
Study Start
February 1, 2007
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
November 17, 2016
Record last verified: 2016-11