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Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate (ALIGHT-COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Aclidinium 200 μg / formoterol 12 μg
Placebo
Formoterol 12 μg
Aclidinium 200 μg
Aclidinium 200 μg / Formoterol 6 μg
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Bronchitis, Chronic, Emphysema

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive.
  2. Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification
  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 400 mcg 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. Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).
  6. Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.
  7. Patient whose COPD symptoms and FEV1 values at the time of randomisation are stable compared to the Screening Visit, according to the investigator's medical judgment

Exclusion Criteria:

  1. History or current diagnosis of asthma or exercise-induced bronchospasm.
  2. Clinically significant respiratory conditions 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. Patient who has a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit.
  6. Clinically significant cardiovascular conditions
  7. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
  8. Presence of narrow-angle glaucoma.
  9. QTc [calculated according to Bazett's formulae (QTc=QT/RR1/2) above 470 milliseconds in the ECG performed at Screening Visit,
  10. Patient who does not maintain regular day/night, waking/sleeping cycles

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Formoterol 12 μg

Placebo

Aclidinium 200 μg / formoterol 12 μg

Aclidinium 200 μg / formoterol 6 μg

Aclidinium 200 μg

Arm Description

Formoterol fumarate 12 μg twice daily

Placebo twice daily

Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily

Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily

Aclidinium bromide 200 μg twice daily

Outcomes

Primary Outcome Measures

Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose

Secondary Outcome Measures

Change From Baseline in Morning Pre-dose FEV1 at Day 14
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes
Change From Baseline in Morning Peak FEV1 at Day 14
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose

Full Information

First Posted
March 1, 2010
Last Updated
January 5, 2017
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01078623
Brief Title
Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate
Acronym
ALIGHT-COPD
Official Title
Efficacy, Safety and Tolerability of Two Fixed-Dose Combinations of Aclidinium Bromide With Two Doses of Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo All Administered Twice Daily in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 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 purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD. Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 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
Keywords
Bronchitis, Chronic, Emphysema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formoterol 12 μg
Arm Type
Active Comparator
Arm Description
Formoterol fumarate 12 μg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice daily
Arm Title
Aclidinium 200 μg / formoterol 12 μg
Arm Type
Experimental
Arm Description
Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily
Arm Title
Aclidinium 200 μg / formoterol 6 μg
Arm Type
Experimental
Arm Description
Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily
Arm Title
Aclidinium 200 μg
Arm Type
Experimental
Arm Description
Aclidinium bromide 200 μg twice daily
Intervention Type
Drug
Intervention Name(s)
Aclidinium 200 μg / formoterol 12 μg
Intervention Description
Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo control twice daily
Intervention Type
Drug
Intervention Name(s)
Formoterol 12 μg
Intervention Description
Formoterol fumarate 12 μg twice daily
Intervention Type
Drug
Intervention Name(s)
Aclidinium 200 μg
Intervention Description
Aclidinium bromide 200 μg twice daily
Intervention Type
Drug
Intervention Name(s)
Aclidinium 200 μg / Formoterol 6 μg
Intervention Description
Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily
Primary Outcome Measure Information:
Title
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14
Description
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose
Time Frame
0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14
Secondary Outcome Measure Information:
Title
Change From Baseline in Morning Pre-dose FEV1 at Day 14
Description
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes
Time Frame
Day 14
Title
Change From Baseline in Morning Peak FEV1 at Day 14
Description
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose
Time Frame
0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive. Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification 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 400 mcg 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%). Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%). Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained. Patient whose COPD symptoms and FEV1 values at the time of randomisation are stable compared to the Screening Visit, according to the investigator's medical judgment Exclusion Criteria: History or current diagnosis of asthma or exercise-induced bronchospasm. Clinically significant respiratory conditions 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. Patient who has a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit. Clinically significant cardiovascular conditions Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction. Presence of narrow-angle glaucoma. QTc [calculated according to Bazett's formulae (QTc=QT/RR1/2) 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
Research Site
City
Bucuresti
Country
Czech Republic
Facility Name
Research Site
City
Constanta
Country
Czech Republic
Facility Name
Research Site
City
Iasi
Country
Czech Republic
Facility Name
Research Site
City
Tg Mures
Country
Czech Republic
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Cluj Napoca
Country
Romania
Facility Name
Research Site
City
Deva
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Oradea
Country
Romania
Facility Name
Research Site
City
Timisoara
Country
Romania

12. IPD Sharing Statement

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=3971&filename=Synopsis%20m-40464-26-Final.pdf
Description
CSR Synopsis

Learn more about this trial

Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate

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