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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Formoterol 12 μg

Formoterol fumarate 12 μg twice daily

Group Type ACTIVE_COMPARATOR

Formoterol 12 μg

Intervention Type DRUG

Formoterol fumarate 12 μg twice daily

Placebo

Placebo twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo control twice daily

Aclidinium 200 μg / formoterol 12 μg

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

Group Type EXPERIMENTAL

Aclidinium 200 μg / formoterol 12 μg

Intervention Type DRUG

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

Aclidinium 200 μg / formoterol 6 μg

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

Group Type EXPERIMENTAL

Aclidinium 200 μg / Formoterol 6 μg

Intervention Type DRUG

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

Aclidinium 200 μg

Aclidinium bromide 200 μg twice daily

Group Type EXPERIMENTAL

Aclidinium 200 μg

Intervention Type DRUG

Aclidinium bromide 200 μg twice daily

Interventions

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Aclidinium 200 μg / formoterol 12 μg

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

Intervention Type DRUG

Placebo

Placebo control twice daily

Intervention Type DRUG

Formoterol 12 μg

Formoterol fumarate 12 μg twice daily

Intervention Type DRUG

Aclidinium 200 μg

Aclidinium bromide 200 μg twice daily

Intervention Type DRUG

Aclidinium 200 μg / Formoterol 6 μg

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No