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Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Aclidinium bromide 100 μg bid
Aclidinium bromide 200 μg bid
Aclidininum bromide 400 μg bid
Placebo
Formoterol 12 μg bid
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

Eligibility Criteria

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

Inclusion Criteria:

  1. Males and non-pregnant, non-lactating females aged ≥ 40.
  2. Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC < 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC <70%).
  3. Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
  4. Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of salbutamol is 30% < FEV1 <80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and ≥ 30%).
  5. Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception.
  6. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.

Exclusion Criteria:

  1. History or current diagnosis of asthma.
  2. Clinically significant respiratory conditions other than COPD at the time of Inform Consent signature
  3. Hospitalisation due to COPD exacerbation within the previous 3 months.
  4. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.
  5. Clinically significant cardiovascular conditions
  6. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
  7. Presence of narrow-angle glaucoma.
  8. QTcB) above 470 milliseconds in the ECG performed at Screening Visit,
  9. Patient who does not maintain regular day/night, waking/sleeping cycles

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Aclidinium bromide 100 μg bid

Aclidininum bromide 200 μg bid

Aclidininum bromide 400 μg bid

Placebo

Formoterol 12 μg bid

Arm Description

Aclidininum bromide 100 μg twice daily by inhalation

Aclidininum bromide 200 μg twice daily by inhalation

Aclidininum bromide 400 μg twice daily by inhalation

Placebo twice-daily by inhalation

Formoterol 12 μg twice daily by inhalation

Outcomes

Primary Outcome Measures

Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment

Secondary Outcome Measures

Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment
Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment

Full Information

First Posted
May 7, 2010
Last Updated
November 17, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01120093
Brief Title
Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.
Official Title
Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator All Administered Twice Daily by Inhalation in Patients With Stable Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD).
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (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 present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

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 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aclidinium bromide 100 μg bid
Arm Type
Experimental
Arm Description
Aclidininum bromide 100 μg twice daily by inhalation
Arm Title
Aclidininum bromide 200 μg bid
Arm Type
Experimental
Arm Description
Aclidininum bromide 200 μg twice daily by inhalation
Arm Title
Aclidininum bromide 400 μg bid
Arm Type
Experimental
Arm Description
Aclidininum bromide 400 μg twice daily by inhalation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice-daily by inhalation
Arm Title
Formoterol 12 μg bid
Arm Type
Active Comparator
Arm Description
Formoterol 12 μg twice daily by inhalation
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide 100 μg bid
Intervention Description
Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide 200 μg bid
Intervention Description
Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Intervention Type
Drug
Intervention Name(s)
Aclidininum bromide 400 μg bid
Intervention Description
Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo via inhalation in the morning and evening for 7 days
Intervention Type
Drug
Intervention Name(s)
Formoterol 12 μg bid
Intervention Description
Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days
Primary Outcome Measure Information:
Title
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment
Time Frame
Day 7
Title
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment
Time Frame
Day 7
Title
Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and non-pregnant, non-lactating females aged ≥ 40. Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC < 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC <70%). Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years. Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of salbutamol is 30% < FEV1 <80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and ≥ 30%). Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent. Exclusion Criteria: History or current diagnosis of asthma. Clinically significant respiratory conditions other than COPD at the time of Inform Consent signature Hospitalisation due to COPD exacerbation within the previous 3 months. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks. Clinically significant cardiovascular conditions Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction. Presence of narrow-angle glaucoma. QTcB) above 470 milliseconds in the ECG performed at Screening Visit, Patient who does not maintain regular day/night, waking/sleeping cycles
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
Almirall Investigational Sites#1
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Almirall Investigational Sites#3
City
Berlín
ZIP/Postal Code
10117
Country
Germany
Facility Name
Almirall Investigational Sites#4
City
Berlín
ZIP/Postal Code
13125
Country
Germany
Facility Name
Almirall Investigational Sites#9
City
Berlín
ZIP/Postal Code
14050
Country
Germany
Facility Name
Almirall Investigational Sites#8
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Almirall Investigational Sites#1
City
Groβhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Almirall Investigational Sites#5
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Almirall Investigational Sites#7
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Almirall Investigational Sites#2
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Almirall Investigational Sites#6
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Almirall Investigational Sites#10
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22497752
Citation
Singh D, Magnussen H, Kirsten A, Mindt S, Caracta C, Seoane B, Jarreta D, Garcia Gil E. A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients. Pulm Pharmacol Ther. 2012 Jun;25(3):248-53. doi: 10.1016/j.pupt.2012.03.008. Epub 2012 Apr 4. Erratum In: Pulm Pharmacol Ther. 2013 Apr;26(2):305.
Results Reference
derived
Links:
URL
http://www.almirall.com/webcorp2/cda/ImD_04_02.jsp
Description
Almirall Corporate Website
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3977&filename=Synopsis_m-34273-29-Final.pdf
Description
CSR Synopsis

Learn more about this trial

Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.

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