Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease (ASA-COPD)

Medical University of Vienna

Status and phase: Unknown; Phase 2

Conditions: COPD

Treatments: Drug: Acetylsalicylic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01328145

2010-022123-29

Details and patient eligibility

About

The pathomechanisms of COPD are still not fully understood, and up to now there is no satisfying causal treatment inhibiting the progress of the disease. Available therapy is in most cases symptomatic. Experimental and clinical observations suggest that treatment with ASA might be beneficial in the treatment of COPD in terms of respiratory and lung-functional improvement.

To evaluate the efficacy of ASA as add-on therapy in COPD in comparison to placebo a prospective, randomized, double-blind, placebo controlled study will be conducted. Adult male and female patients (n=74) with proven COPD GOLD grade II-III will be randomized to 2 groups (i.e. 37 patients per group, stratification according to smoking status and gender). They will receive either 500 mg ASA per day or matching placebo over 12 weeks. Primary efficacy endpoints are changes in the lung-functional parameter FEV1 (forced expiratory 1-second volume) after 12 weeks of treatment. Secondary endpoints are the health score of the St. Georges respiratory questionnaire (SGRQ) and Peak-flow (PEF).

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD GOLD II or III

Exclusion criteria

• Long term NSAIDS, pregnancy et al.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

ASA

Active Comparator group

Treatment:

Drug: Acetylsalicylic acid

Placebo

Placebo Comparator group

Treatment:

Drug: Acetylsalicylic acid