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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Aclidinium bromide 100 μg bid; Drug: Aclidinium bromide 200 μg bid; Drug: Formoterol 12 μg bid; Drug: Aclidininum bromide 400 μg bid; Drug: Placebo

• Registration Number: NCT01120093
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-07
• Study First Submitted QC: 2010-05-07
• Study First Posted: 2010-05-10
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2012-08-14
• Results First Submitted QC: 2012-08-14
• Results First Posted: 2012-09-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aclidinium bromide 100 μg bid	Aclidinium bromide 100 μg bid	Aclidininum bromide 100 μg twice daily by inhalation
Aclidininum bromide 200 μg bid	Aclidinium bromide 200 μg bid	Aclidininum bromide 200 μg twice daily by inhalation
Formoterol 12 μg bid	Formoterol 12 μg bid	Formoterol 12 μg twice daily by inhalation
Aclidininum bromide 400 μg bid	Aclidininum bromide 400 μg bid	Aclidininum bromide 400 μg twice daily by inhalation
Placebo	Placebo	Placebo twice-daily by inhalation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (10)

Almirall Investigational Sites#9; 🇩🇪 Berlín, Germany

Almirall Investigational Sites#6; 🇩🇪 Schwerin, Germany

Almirall Investigational Sites#4; 🇩🇪 Berlín, Germany

Almirall Investigational Sites#1; 🇩🇪 Groβhansdorf, Germany

Almirall Investigational Sites#2; 🇩🇪 Hannover, Germany

Almirall Investigational Sites#3; 🇩🇪 Berlín, Germany

Almirall Investigational Sites#8; 🇩🇪 Frankfurt, Germany

Almirall Investigational Sites#5; 🇩🇪 Hamburg, Germany

Almirall Investigational Sites#7; 🇩🇪 Hannover, Germany

Almirall Investigational Sites#10; 🇩🇪 Wiesbaden, Germany