Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

Phase 3

Completed

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

• Registration Number: NCT01001494
• Lead Sponsor: AstraZeneca

Brief Summary

The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2012-08-14
• Results First Submitted QC: 2012-08-14
• Results First Posted: 2012-09-17
• Status Verified: 2016-10
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 828

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aclidininum bromide 400 μg bid	Aclidinium bromide 400 μg bid	Aclidinium bromide 400 μg twice-daily via inhalation
Aclidinium bromide 200 μg bid	Aclidinium bromide 200 μg bid	Aclidinium bromide 200 μg twice-daily via inhalation
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment	Baseline and Week 24
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment	Baseline and Week 12

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment	Baseline and Week 24
Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment	Week 24	Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment	Week 24	Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment

Trial Locations

Locations (28)

Almirall Investigational Site#11; 🇵🇱 Proszowice, Poland

Almirall Investigational Sites#24; 🇵🇱 Olsztyn, Poland

Almirall Investigational Sites#25; 🇵🇱 Warszawa, Poland

Almirall Investigational Sites#23; 🇵🇱 Wilkowice-Bystra, Poland

Almirall Investigational Sites#2; 🇺🇦 Kyiv, Ukraine

Almirall Investigational Sites#3; 🇺🇦 Kharkiv, Ukraine

Almirall Investigational Sites#4; 🇺🇦 Donetsk, Ukraine

Almirall Investigational Site#7; 🇩🇪 Berlin, Germany

Almirall Investigational Sites#9; 🇿🇦 George, South Africa

Almirall Investigational Sites#11; 🇿🇦 Bloemfontein, South Africa

Almirall Investigational Sites#6; 🇪🇸 Badalona, Spain

Almirall Investigational Sites#12; 🇿🇦 Cape Town, South Africa

Almirall Investigational Sites#1; 🇺🇦 Kyiv, Ukraine

Almirall Investigational Sites#7; 🇺🇦 Kyiv, Ukraine

Almirall Investigational Sites#21; 🇵🇱 Poznan, Poland

Almirall Investigational Sites#8; 🇪🇸 Barcelona, Spain

Almirall Investigational Sites#10; 🇿🇦 Cape Town, South Africa

Almirall Investigational Sites#13; 🇷🇺 Novosibirsk, Russian Federation

Almirall Investigational Sites#5; 🇺🇦 Zaporizhzhya, Ukraine

Almirall Investigational Sites#14; 🇿🇦 Pretoria, South Africa

Almirall Investigational Sites#15; 🇿🇦 Cape Town, South Africa

Almirall Investigational Sites#20; 🇵🇱 Ilawa, Poland

Almirall Investigational Sites#16; 🇵🇱 Poznan, Poland

Almirall Investigational Site#16; 🇩🇪 Hannover, Germany

Almirall Investigational Site#2; 🇩🇪 Rüdersdorf, Germany

Almirall Investigational Sites#18; 🇵🇱 Gdansk, Poland

Almirall Investigational Sites#19; 🇵🇱 Elblag, Poland

Almirall Investigational Site#10; 🇵🇱 Wrocław, Poland