Effect of Acetazolamide on Lung Water Content by Ultrasound in Patients With Respiratory Disease at Altitude

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: ACETAZOLAMIDE oral capsule; Drug: Placebo oral capsule

• Registration Number: NCT03540901
• Lead Sponsor: University of Zurich

Brief Summary

This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on lung water content by ultrasound at acute altitude exposure in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on lung water content by ultrasound 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 (3100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3100 m.

Study Timeline

• Study First Submitted: 2018-05-15
• Study Start: 2018-05-22
• Study First Submitted QC: 2018-05-28
• Study First Posted: 2018-05-30
• Primary Completion: 2018-08-02
• Study Completion: 2018-08-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-04
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Male and female patients, age 18-75 yrs.
• COPD diagnosed according to GOLD, FEV1 40-80% predicted, Oxygen Saturation (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/Forced Vital Capacity <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; obstructive sleep apnea; 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACETAZOLAMIDE oral capsule	ACETAZOLAMIDE oral capsule	375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3100m until the morning after the second night at 3100m
PLACEBO oral capsule	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 3100m until the morning after the second night at 3100m.

Primary Outcome Measures

Name	Time	Method
Difference in change of ultrasound lung comets from 760 m baseline measurement to measurement at 3100 m in the acetazolamide compared to the placebo group	Day 2 at 760m and 3100m	Difference in change of ultrasound lung comets from 760 m baseline measurement to measurement at 3100 m in the acetazolamide compared to the placebo group

Secondary Outcome Measures

Name	Time	Method
Change of ultrasound lung comets from 760 m baseline measurement to measurement at 3100 m in the acetazolamide and in the placebo group, respectively	Day 2 at 3100m	Change of ultrasound lung comets from 760 m baseline measurement to measurement at 3100 m in the acetazolamide and in the placebo group, respectively

Trial Locations

Locations (1)

National Center of Cardiology and Internal Medicine; 🇰🇬 Biskek, Kyrgyzstan