ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03156231
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborator:
National Center of Cardiology and Internal Medicine, Kyrgyzstan
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: ACETAZOLAMIDE oral capsule Drug: Placebo oral capsule Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Acetazolamide for Prevention of Altitude Related Illness in Patients With Chronic Obstructive Pulmonary Disease (COPD). Randomized, Placebo-Controlled, Double-Blind Trial.
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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
Drug: ACETAZOLAMIDE oral capsule
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m

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.
Drug: Placebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. Spirometry [ Time Frame: Day 2 at 760m and 3200m ]
    Difference in altitude-induced change in the spirometric variables between the acetazolamide and placebo group

  5. 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

  6. 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

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156231


Contacts
Contact: Konrad E Bloch, MD +41442553828 konrad.bloch@usz.ch
Contact: Michael Furian, MSc +41442553828 michael.furian@usz.ch

Locations
Kyrgyzstan
National Center of Cardiology and Internal Medicine Recruiting
Bishkek, Kyrgyzstan, 720040
Contact: Talant M Sooronbaev, MD    +996 312 625679    Sooronbaev@yahoo.com   
Sponsors and Collaborators
University of Zurich
National Center of Cardiology and Internal Medicine, Kyrgyzstan
Investigators
Study Chair: Konrad E Bloch, MD University Hospital, Zürich
Study Director: Talant M Sooronbaev, MD National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03156231     History of Changes
Other Study ID Numbers: 2017-00137
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
airway disease
bronchitis
emphysema
altitude
prevention
acetazolamide

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs