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History of Changes for Study: NCT01001494
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Latest version (submitted November 16, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 23, 2009 None (earliest Version on record)
2 October 26, 2009 Outcome Measures and Study Status
3 November 2, 2009 Contacts/Locations and Study Status
4 November 6, 2009 Contacts/Locations and Study Status
5 January 8, 2010 Study Status and Study Identification
6 January 18, 2010 Study Status
7 January 25, 2010 Contacts/Locations and Study Status
8 January 29, 2010 Contacts/Locations and Study Status
9 March 9, 2010 Contacts/Locations and Study Status
10 April 1, 2010 Contacts/Locations and Study Status
11 May 3, 2010 Study Status and Contacts/Locations
12 June 2, 2010 Recruitment Status, Contacts/Locations and Study Status
13 July 2, 2010 Study Status
14 July 8, 2010 Study Status
15 July 9, 2010 References and Study Status
16 August 6, 2010 Study Status and Contacts/Locations
17 September 27, 2010 Study Status
18 October 21, 2010 Study Status and Contacts/Locations
19 November 5, 2010 Study Status
20 December 9, 2010 Study Status
21 December 16, 2010 Recruitment Status and Study Status
22 January 12, 2011 Study Status
23 March 29, 2012 Sponsor/Collaborators, Study Design and Study Status
24 August 14, 2012 Arms and Interventions, Study Status, Outcome Measures and Results
25 July 2, 2015 Outcome Measures, Study Status, Baseline Characteristics and Conditions
26 October 5, 2016 Sponsor/Collaborators, Contacts/Locations, Study Status and Study Identification
27 November 16, 2016 More Information, Study Status and Baseline Characteristics
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Study NCT01001494
Submitted Date:  October 23, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: M/34273/34
Brief Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2009
Overall Status: Recruiting
Study Start: October 2009
Primary Completion: July 2011 [Anticipated]
Study Completion: July 2011 [Anticipated]
First Submitted: October 22, 2009
First Submitted that
Met QC Criteria:
October 23, 2009
First Posted: October 26, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 23, 2009
Last Update Posted: October 26, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Almirall, S.A.
Responsible Party:
Collaborators: Forest Laboratories
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.
Detailed Description:
Open or close this module Conditions
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
antimuscarinic
COPD
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 810 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Aclidinium bromide 1st arm
Aclidinium bromide
Drug: Aclidinium bromide
Aclidinium bromide two dose levels administered via Genuair dry powder inhaler during 6 months
Experimental: Aclidininum bromide 2nd arm
Aclidininum bromide
Drug: Aclidinium bromide
Aclidinium bromide two dose levels administered via Genuair dry powder inhaler during 6 months
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from baseline in morning pre-dose (through) Forced Expiratory Volume in the first second (FEV1)
[ Time Frame: week 12 and 24 ]

Secondary Outcome Measures:
1. Change from baseline in peak FEV1
[ Time Frame: week 12 and 24 ]

2. Number (%) of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score
[ Time Frame: week 24 ]

3. Number (%) of patients achieving a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score
[ Time Frame: week 24 ]

4. Adverse Events, laboratory, Electrocardiogram and vital signs
[ Time Frame: week 4, 12 and 24 ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
  • Post-salbutamol (FEV1) < 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
  • Current or ex-smokers of ≥10 pack-years.

Exclusion Criteria:

  • Patients with no history or current diagnosis of asthma.
  • No evidence of an exacerbation within 6 weeks prior to the screening visit.
  • No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
  • No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Open or close this module Contacts/Locations
Central Contact Person: Estrella Garcia, Ph.D.
Email: estrella.garcia@almirall.com
Study Officials: Estrella Garcia, Ph.D.
Study Director
Almirall, S.A.
Locations: Czech Republic
Almirall Investigational Sites
[Not yet recruiting]
Multicenter, Czech Republic
France
Almirall Investigational Sites
[Not yet recruiting]
Multicenter, France
Germany
Almirall Investigational Sites
[Recruiting]
Multicenter, Germany
Hungary
Almirall Investigational Sites
[Not yet recruiting]
Multicenter, Hungary
Italy
Almirall Investigational Sites
[Not yet recruiting]
Multicenter, Italy
Spain
Almirall Investigational Sites
[Not yet recruiting]
Multicenter, Spain
United Kingdom
Almirall Investigational Sites
[Not yet recruiting]
Multicenter, United Kingdom
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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