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Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide 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
Tiotropium
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 (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.

Sites / Locations

  • Almirall Investigational Site #9
  • Almirall Investigational Site #1
  • Almirall Investigational Site #3
  • Almirall Investigational Site #4
  • Almirall Investigational Site #12
  • Almirall Investigational Site #10
  • Almirall Investigational Site #8
  • Almirall Investigational Site #20
  • Almirall Investigational Site #21
  • Almirall Investigational Site #2
  • Almirall Investigational Site #13
  • Almirall Investigational Site #9
  • Almirall Investigational Site #3
  • Almirall Investigational Site #1
  • Almirall Investigational Site #18
  • Almirall Investigational Site #5
  • Almirall Investigational Site #22
  • Almirall Investigational Site #14
  • Almirall Investigational Site #24
  • Almirall Investigational Site #17
  • Almirall Investigational Site #23
  • Almirall Investigational Site #6
  • Almirall Investigational Site #16
  • Almirall Investigational Site #4
  • Almirall Investigational Site #2
  • Almirall Investigational Site #3
  • Almirall Investigational Site #1
  • Almirall Investigational Site #11
  • Almirall Investigational Site #18
  • Almirall Investigational Site #8
  • Almirall Investigational Site #2
  • Almirall Investigational Site #17
  • Almirall Investigational Site #10
  • Almirall Investigational Site #16
  • Almirall Investigational Site #20
  • Almirall Investigational Site #4
  • Almirall Investigational Site #6
  • Almirall Investigational Site #14
  • Almirall Investigational Site #19
  • Almirall Investigational Site #12
  • Almirall Investigational Site #13

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Aclidinium bromide

Tiotropium

Placebo

Arm Description

Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment

Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment

Placebo comparator administered during 6 weeks of treatment

Outcomes

Primary Outcome Measures

Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment
Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.

Secondary Outcome Measures

Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment
Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.

Full Information

First Posted
October 28, 2011
Last Updated
November 16, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01462929
Brief Title
Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Multiple Dose, Double-blind, Double-dummy, Placebo Controlled, Parallel Clinical Trial to Assess the Efficacy and Safety of Twice Daily Inhaled Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 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 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
414 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aclidinium bromide
Arm Type
Experimental
Arm Description
Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment
Arm Title
Tiotropium
Arm Type
Active Comparator
Arm Description
Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparator administered during 6 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide
Intervention Description
Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).
Primary Outcome Measure Information:
Title
Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment
Description
Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment
Description
Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.
Time Frame
Week 6

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 (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.
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 #9
City
Humpolec
ZIP/Postal Code
396 26
Country
Czech Republic
Facility Name
Almirall Investigational Site #1
City
Jaromer
ZIP/Postal Code
551 01
Country
Czech Republic
Facility Name
Almirall Investigational Site #3
City
Melnik
ZIP/Postal Code
276 01
Country
Czech Republic
Facility Name
Almirall Investigational Site #4
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Almirall Investigational Site #12
City
Berlin
ZIP/Postal Code
10717
Country
Germany
Facility Name
Almirall Investigational Site #10
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Almirall Investigational Site #8
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Almirall Investigational Site #20
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Almirall Investigational Site #21
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Almirall Investigational Site #2
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
Almirall Investigational Site #13
City
Dresden
Country
Germany
Facility Name
Almirall Investigational Site #9
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Almirall Investigational Site #3
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Almirall Investigational Site #1
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Almirall Investigational Site #18
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Almirall Investigational Site #5
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Almirall Investigational Site #22
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Almirall Investigational Site #14
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Almirall Investigational Site #24
City
Koln
ZIP/Postal Code
51069
Country
Germany
Facility Name
Almirall Investigational Site #17
City
Lubeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Almirall Investigational Site #23
City
Rudersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Almirall Investigational Site #6
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Almirall Investigational Site #16
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
Facility Name
Almirall Investigational Site #4
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Almirall Investigational Site #2
City
Komarom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Almirall Investigational Site #3
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Almirall Investigational Site #1
City
Szarvas
ZIP/Postal Code
5540
Country
Hungary
Facility Name
Almirall Investigational Site #11
City
Szigetszentmiklos
ZIP/Postal Code
2310
Country
Hungary
Facility Name
Almirall Investigational Site #18
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Almirall Investigational Site #8
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Almirall Investigational Site #2
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Almirall Investigational Site #17
City
Krakow
ZIP/Postal Code
31-023
Country
Poland
Facility Name
Almirall Investigational Site #10
City
Krakow
ZIP/Postal Code
31-455
Country
Poland
Facility Name
Almirall Investigational Site #16
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Almirall Investigational Site #20
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Almirall Investigational Site #4
City
Proszowice
ZIP/Postal Code
32-100
Country
Poland
Facility Name
Almirall Investigational Site #6
City
Sopot
ZIP/Postal Code
84-741
Country
Poland
Facility Name
Almirall Investigational Site #14
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Almirall Investigational Site #19
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Almirall Investigational Site #12
City
Wilkowice-Bystra
ZIP/Postal Code
43-365
Country
Poland
Facility Name
Almirall Investigational Site #13
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28074135
Citation
McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3975&filename=Synopsis-las39-Final.pdf
Description
CSR Synopsis

Learn more about this trial

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

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