A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

AstraZeneca843 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

843

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Aclidinium bromideDRUG

Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks

PlaceboDRUG

Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (132)

Outcomes

Primary Outcomes

Trough FEV1 (L) at 28 Weeks on Treatment

Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks

Time frame: Week 28

Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment

Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks

Time frame: Week 12

Secondary Outcomes

Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment

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.

Time frame: Week 52

Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment

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

Time frame: 52 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Almirall Investigational Sites#947

Les Escaldes, Andorra

Almirall Investigational Sites#645

Graz, Austria

Almirall Investigational Sites#646

Innsbruck, Austria

Almirall Investigational Sites#644

Linz, Austria

Almirall Investigational Sites#647

Vienna, Austria

Almirall Investigational Sites#649

Vienna, Austria

Almirall Investigational Sites#110

Aalst, Belgium

Almirall Investigational Sites#394

Brussels, Belgium

Almirall Investigational Sites#651

Edegem, Belgium

Almirall Investigational Sites#393

Namur, Belgium

...and 122 more locations