Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD

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Brief Title

Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD

Official Title

Novel Approach to Prevention of Altitude-related Illness in Patients With Chronic Obstructive Pulmonary Disease

Brief Summary

      The purpose of this randomized, placebo-controlled double-blind trial is to evaluate efficacy
      of acetazolamide in preventing overt altitude-related adverse health effects (ARAHE) in
      lowlanders with chronic obstructive pulmonary disease (COPD) developing early signs of
      altitude-illness during altitude travel.
    

Detailed Description

      This randomized placebo-controlled, double-blind, parallel-design trial will evaluate
      effectiveness of acetazolamide in reducing the incidence of predefined altitude-related
      adverse health effects in lowlanders with chronic obstructive pulmonary disease (COPD)
      travelling to high altitude and developping early symptoms and/or signs of impending
      altitude-illness. Qualifying participants will be randomized 1:1 to acetazolamide or placebo
      treatment during their further stay of 2 days at 3'100 m.

      An interim-analysis will be performed after the first year of the study or when 38
      participants are randomized, whichever comes first. Symmetric stopping boundaries at P<0.001
      will be applied (Peto approach).
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Incidence of altitude-related adverse health effects

Secondary Outcome

 Incidence and severity of the individual components of altitude-related adverse health effects

Condition

Chronic Obstructive Pulmonary Disease

Intervention

Acetazolamide

Study Arms / Comparison Groups

 Acetazolamide
Description:  Acetazolamide (oral capsules)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

June 1, 2021

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2022

Eligibility Criteria

        Inclusion criteria

          -  Men and women, age 35-75 y, living at low altitude (<800 m).

          -  COPD diagnosed according to the Global Initiative for Obstructive Lung Disease (GOLD)
             guidelines, forced expiratory volume in one second 40-80% predicted, pulse oximetry
             ≥92%, PaCO2 <6 kilopascal, breathing ambient air at 760 m.

          -  One of the following early signs and/or symptoms of impending altitude-illness
             identified by self-monitoring during ascent to or stay at 3100 m:

               -  Pulse oximetry SpO2≤84%

               -  Headache or nausea/vomiting or fatigue/weakness or dizziness/light-headedness of
                  at least moderate intensity

        Exclusion criteria

          -  COPD exacerbation, very severe COPD with hypoxemia or hypercapnia at 760 m (see
             above).

          -  Other lung disease, relevant comorbidities (such as uncontrolled cardiovascular
             disease, i.e., unstable arterial hypertension, coronary artery disease; previous
             stroke; obesity (body mass index >35 kg/m2); internal, neurologic, rheumatologic or
             psychiatric disease; current heavy smoking (>20 cigarettes per day).

          -  Renal failure and/or allergy to sulfonamides.

          -  Patients who do not have early signs and/or signs of impending altitude-illness by
             self-monitoring (as defined above) at 3'100m will not be included.
      

Gender

All

Ages

35 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Konrad E Bloch, +41442553828, [email protected]

Location Countries

Kyrgyzstan

Location Countries

Kyrgyzstan

Administrative Informations


NCT ID

NCT04913389

Organization ID

01-2021-KEB


Responsible Party

Sponsor

Study Sponsor

University of Zurich

Collaborators

 National Center of Cardiology and Internal Medicine, Kyrgyz Republic

Study Sponsor

Konrad E Bloch, Study Chair, University Hospital, Zürich, Switzerland


Verification Date

June 2021