search
Back to results

Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aclidinium Bromide
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Antimuscarinic

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
  • Post-salbutamol Forced Expiratory Volume in one second(FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) < 70%.
  • Current or ex-smokers of ≥ 10 pack-years
  • Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value

Exclusion Criteria:

  • History or current diagnosis of asthma
  • Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
  • Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
  • Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
  • Patients with an oxygen saturation < 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
  • Contra-indications of cardiopulmonary exercise testing.
  • Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.

Sites / Locations

  • Almirall Investigational Site #10
  • Almirall Investigational Site #6
  • Almirall Investigational Site #2
  • Almirall Investigational Site #4
  • Almirall Investigational Site #5
  • Almirall Investigational Site #8
  • Almirall Investigational Site #9
  • Almirall Investigational Site #3
  • Almirall Investigational Site #7
  • Almirall Investigational Site #1
  • Almirall Investigational Site #1
  • Almirall Investigational Site #4
  • Almirall Investigational Site #2
  • Almirall Investigational Site #2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aclidinium bromide

Placebo

Arm Description

3-week treatment periods

3-week treatment periods

Outcomes

Primary Outcome Measures

Change From Baseline in Endurance Time (Seconds)
Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.

Secondary Outcome Measures

Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)
Change from baseline in trough IC after 3 weeks of treatment
Change From Baseline in Intensity of Dyspnoea
Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment.

Full Information

First Posted
November 10, 2011
Last Updated
November 16, 2016
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT01471171
Brief Title
Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Multiple Dose, Randomised, Double-blind, Placebo Controlled, 2 Period Crossover Clinical Trial to Assess the Effect of Aclidinium Bromide 400 μg BID on Exercise Endurance in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.

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, Antimuscarinic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aclidinium bromide
Arm Type
Experimental
Arm Description
3-week treatment periods
Arm Title
Placebo
Arm Type
Experimental
Arm Description
3-week treatment periods
Intervention Type
Drug
Intervention Name(s)
Aclidinium Bromide
Intervention Description
1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)
Primary Outcome Measure Information:
Title
Change From Baseline in Endurance Time (Seconds)
Description
Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.
Time Frame
Week 3
Secondary Outcome Measure Information:
Title
Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)
Description
Change from baseline in trough IC after 3 weeks of treatment
Time Frame
Week 3
Title
Change From Baseline in Intensity of Dyspnoea
Description
Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment.
Time Frame
Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines). Post-salbutamol Forced Expiratory Volume in one second(FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) < 70%. Current or ex-smokers of ≥ 10 pack-years Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value Exclusion Criteria: History or current diagnosis of asthma Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period. Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities. Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma. Patients with an oxygen saturation < 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1. Contra-indications of cardiopulmonary exercise testing. Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Garcia, Ph.D.
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Almirall Investigational Site #10
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Almirall Investigational Site #6
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Almirall Investigational Site #2
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Almirall Investigational Site #4
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Almirall Investigational Site #5
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Almirall Investigational Site #8
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Almirall Investigational Site #9
City
Hamburg
ZIP/Postal Code
22335
Country
Germany
Facility Name
Almirall Investigational Site #3
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Almirall Investigational Site #7
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Almirall Investigational Site #1
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
Facility Name
Almirall Investigational Site #1
City
Alicante
ZIP/Postal Code
03114
Country
Spain
Facility Name
Almirall Investigational Site #4
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Almirall Investigational Site #2
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Almirall Investigational Site #2
City
London
ZIP/Postal Code
W1G 8HU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25539654
Citation
Beeh KM, Watz H, Puente-Maestu L, de Teresa L, Jarreta D, Caracta C, Garcia Gil E, Magnussen H. Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial. BMC Pulm Med. 2014 Dec 23;14:209. doi: 10.1186/1471-2466-14-209.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3974&filename=Synopsis-las40-Final.pdf
Description
CSR Synopsis

Learn more about this trial

Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

We'll reach out to this number within 24 hrs