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Effect Of Acetazolamide On Altitude Related Illness In Patients With Respiratory Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03156231
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE May 15, 2017
First Posted Date  ICMJE May 17, 2017
Last Update Posted Date January 29, 2019
Actual Study Start Date  ICMJE May 24, 2017
Actual Primary Completion Date August 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
Altitude related adverse health effects (ARAHE), cumulative incidence [ Time Frame: Day 1 to 3 at 3200m ]
Difference between acetazolamide and placebo group in cumulative incidence of ARAHE during the stay at 3200 m. ARAHE are defined as the following:
  • Moderate to severe AMS (Lake Louise score ≥3 and/or Environmental Symptoms questionnaire AMSc score ≥0.7) and/or any of the following:
  • Severe hypoxemia (SpO2 at rest <80% for >30 min or <75% for >15 min, exercise oxygen desaturation SpO2 <75% for >1 min accompanied by symptoms or signs of hypoxemia)
  • Symptomatic cardiovascular disease (arterial blood pressure systolic >200 mmHg, diastolic >110 mmHg not responding to blood pressure lowering drugs within 1 hr; chest pain with ECG signs of ischemia or new onset arrhythmia)
  • Withdrawal from the study by the decision of the independent physician for safetey reasons or by the patient
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03156231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
  • Acute mountain sickness, severity [ Time Frame: Day 1 to 3 at 3200m ]
    Difference between acetazolamide and placebo group in the acute mountain sickness severity assessed by the Lake Louise questionnaire.
  • 6 min walk distance [ Time Frame: Day 2 at 760m and 3200m ]
    Difference in altitude-induced change in the distance walked in 6 min between the acetazolamide and placebo group.
  • Perceived exertion [ Time Frame: Day 2 at 760m and 3200m ]
    Difference in altitude-induced change in the perceived exertion rated with the Borg CR10 scale between the acetazolamide and placebo group
  • Spirometry [ Time Frame: Day 2 at 760m and 3200m ]
    Difference in altitude-induced change in the spirometric variables between the acetazolamide and placebo group
  • Arterial blood gases [ Time Frame: Day 2 at 760m and 3200m ]
    Difference in altitude-induced change in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the acetazolamide and placebo group
  • Exercise endurance during constant load cycling ergometry [ Time Frame: Day 3 at 760m and 3200m ]
    Difference in altitude-induced change in exercise endurance between acetazolamide and placebo group, measured by constant load cycling ergometry
  • Side effects [ Time Frame: Day 1 to 3 at 3200m ]
    Difference between acetazolamide and placebo group in the cumulative incidence of medication side effects during the stay at 3200 m.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
  • Acute mountain sickness, severity [ Time Frame: Day 1 to 3 at 3200m ]
    Difference between acetazolamide and placebo group in the acute mountain sickness severity assessed by the Lake Louise questionnaire.
  • 6 min walk distance [ Time Frame: Day 2 at 3200m ]
    Difference in the distance walked in 6 min between the acetazolamide and placebo group.
  • Perceived exertion [ Time Frame: Day 2 at 3200m ]
    Difference in the perceived exertion rated with the Borg CR10 scale between the acetazolamide and placebo group
  • Spirometry [ Time Frame: Day 2 at 3200m ]
    Difference in the spirometric variables between the acetazolamide and placebo group
  • Arterial blood gases [ Time Frame: Day 2 at 3200m ]
    Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the acetazolamide and placebo group
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect Of Acetazolamide On Altitude Related Illness In Patients With Respiratory Disease
Official Title  ICMJE Acetazolamide for Prevention of Altitude Related Illness in Patients With Chronic Obstructive Pulmonary Disease (COPD). Randomized, Placebo-Controlled, Double-Blind Trial.
Brief Summary Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive lung disease travelling from 760 m to 3200 m.
Detailed Description

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis in reducing the incidence of altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

An interim analysis will be carried out when 90 patients will have completed the study or after the first year. The Peto's method will be used to correct the P-values.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Drug: ACETAZOLAMIDE oral capsule
    Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
  • Drug: Placebo oral capsule
    Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Study Arms  ICMJE
  • Active Comparator: ACETAZOLAMIDE oral capsule
    Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m
    Intervention: Drug: ACETAZOLAMIDE oral capsule
  • Placebo Comparator: PLACEBO oral capsule
    Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m.
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2019)
185
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2017)
180
Actual Study Completion Date  ICMJE August 2, 2018
Actual Primary Completion Date August 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients, age 18-75 yrs.
  • COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
  • Born, raised and currently living at low altitude (<800m).
  • Written informed consent.

Exclusion Criteria:

  • COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC <0.7, FEV1 <40% predicted, oxygen saturation on room air <92% at 750 m).
  • Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
  • Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (>20 cigarettes per day)
  • Known renal failure or allergy to acetazolamide and other sulfonamides
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kyrgyzstan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03156231
Other Study ID Numbers  ICMJE 2017-00137
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Investigators  ICMJE
Study Chair: Konrad E Bloch, MD University Hospital, Zürich
Study Director: Talant M Sooronbaev, MD National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
PRS Account University of Zurich
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP