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Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease

NCT ID: NCT01328145

Last Updated: 2012-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ASA

Group Type ACTIVE_COMPARATOR

Acetylsalicylic acid

Intervention Type DRUG

500 mg /day

Placebo

Group Type PLACEBO_COMPARATOR

Acetylsalicylic acid

Intervention Type DRUG

500 mg /day

Interventions

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Acetylsalicylic acid

500 mg /day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* COPD GOLD II or III

Exclusion Criteria

* Long term NSAIDS, pregnancy et al.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Rolf Ziesche

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rolf Ziesche, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Robert Sauermann, MD

Role: CONTACT

Phone: 00431404002981

Email: [email protected]

Facility Contacts

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Robert Sauermann, md

Role: primary

Other Identifiers

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2010-022123-29

Identifier Type: -

Identifier Source: org_study_id