Effect Of Acetazolamide On Altitude Related Illness In Patients With Respiratory Disease
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|ClinicalTrials.gov Identifier: NCT03156231|
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : June 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Drug: ACETAZOLAMIDE oral capsule Drug: Placebo oral capsule||Phase 4|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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
- 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.
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
|Contact: Konrad E Bloch, MDfirstname.lastname@example.org|
|Contact: Michael Furian, MScemail@example.com|
|National Center of Cardiology and Internal Medicine||Recruiting|
|Bishkek, Kyrgyzstan, 720040|
|Contact: Talant M Sooronbaev, MD +996 312 625679 Sooronbaev@yahoo.com|
|Study Chair:||Konrad E Bloch, MD||University Hospital, Zürich|
|Study Director:||Talant M Sooronbaev, MD||National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan|