Back to resultsClinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Aclidinium bromide
Placebo Tiotropium
Tiotropium
Placebo LAS34273
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD
Eligibility Criteria
Inclusion Criteria:
- Males and females aged ≥ 40 years
- Current or ex-smokers of ≥ 10 pack-year
- Clinical diagnosis of severe stable COPD
Exclusion Criteria:
- 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
Sites / Locations
- Respiratory Clinical Trials Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Experimental
Arm Label
Tiotropium
Placebo
Aclidinium bromide
Arm Description
1 puff, 1 day treatment
Tiotropium or Aclidinium Placebo, 1 day treatment
200 micrograms, once daily, 1 day treatment
Outcomes
Primary Outcome Measures
FEV1 Percentage Increase
Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes
Secondary Outcome Measures
Normalised Area FEV1 AUC 0-3h
Normalised area under the curve (AUC) 0-3 hours of FEV1 and change form baseline in FEV1 at 30 min
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00435760
Brief Title
Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
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).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
Detailed Description
This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tiotropium
Arm Type
Active Comparator
Arm Description
1 puff, 1 day treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tiotropium or Aclidinium Placebo, 1 day treatment
Arm Title
Aclidinium bromide
Arm Type
Experimental
Arm Description
200 micrograms, once daily, 1 day treatment
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide
Intervention Description
200 micrograms, once daily, 1 day treatment
Intervention Type
Drug
Intervention Name(s)
Placebo Tiotropium
Intervention Description
1 puff once daily, 1 day treatment
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00
Intervention Type
Drug
Intervention Name(s)
Placebo LAS34273
Intervention Description
1 puff, 1 dat treatment
Primary Outcome Measure Information:
Title
FEV1 Percentage Increase
Description
Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Normalised Area FEV1 AUC 0-3h
Description
Normalised area under the curve (AUC) 0-3 hours of FEV1 and change form baseline in FEV1 at 30 min
Time Frame
0-3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females aged ≥ 40 years
Current or ex-smokers of ≥ 10 pack-year
Clinical diagnosis of severe stable COPD
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Garcia, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Respiratory Clinical Trials Ltd
City
London
ZIP/Postal Code
W1G 8HU
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.almirall.com/webcorp2/cda/ImD_04_02.jsp
Description
Sponsor web site
URL
http://www.frx.com
Description
Co-Sponsor web site
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4055&filename=Synopsis-m-34273-24-Final.pdf
Description
CSR Synopsis
Learn more about this trial
Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
We'll reach out to this number within 24 hrs