Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)

Phase 3

Completed

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

• Registration Number: NCT00358436
• Lead Sponsor: AstraZeneca

Brief Summary

To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-28
• Study First Submitted QC: 2006-07-28
• Study First Posted: 2006-07-31
• Study Start: 2006-08
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2012-08-14
• Results First Submitted QC: 2012-10-31
• Results First Posted: 2012-11-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 804

Inclusion Criteria

• Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria

• History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aclidinium 200 μg once-daily	Aclidinium bromide	Aclidinium bromide 200 μg once-daily by inhalation
Placebo	Placebo	Placebo by inhalation

Primary Outcome Measures

Name	Time	Method
Trough FEV1 (L) at 28 Weeks on Treatment	28 weeks	Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks
Trough FEV1 (L) at 12 Weeks on Treatment	12 weeks	Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment	52 weeks	Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment	52 weeks	Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score

Trial Locations

Locations (118)

Almirall Investigational Sites#926; 🇺🇸 Jasper, Alabama, United States

Almirall Investigational Sites#858; 🇺🇸 Ozark, Alabama, United States

Almirall Investigational Sites#900; 🇺🇸 Phoenix, Arizona, United States

Almirall Investigational Sites#899; 🇺🇸 Tucson, Arizona, United States

Almirall Investigational Sites#855; 🇺🇸 Tucson, Arizona, United States

Almirall Investigational Sites#879; 🇺🇸 Little Rock, Arkansas, United States

Almirall Investigational Sites#932; 🇺🇸 Carmichael, California, United States

Almirall Investigational Sites#904; 🇺🇸 Encinitas, California, United States

Almirall Investigational Sites#903; 🇺🇸 Fullerton, California, United States

Almirall Investigational Sites#930; 🇺🇸 Los Angeles, California, United States

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