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

Effect of Acetazolamide on Lung Water Content by Ultrasound in Patients With Respiratory Disease at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: ACETAZOLAMIDE oral capsule; Drug: Placebo oral capsule

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• Kyrgyzstan
  • Biskek, Kyrgyzstan, 720040
    • National Center of Cardiology and Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: ACETAZOLAMIDE oral capsule; Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3100m
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 3100m until the morning after the second night at 3100m.	Drug: Placebo oral capsule; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3100m

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of ultrasound lung comets from 760 m baseline measurement to measurement at 3100 m in the acetazolamide and in the placebo group, respectively	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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Actual): August 2, 2018
• Study Completion (Actual): August 2, 2018

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 28, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: prevention; acetazolamide; obstructive airway disease; lung water
• Additional Relevant MeSH Terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiration Disorders; Respiratory Tract Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Diuretics; Anticonvulsants; Acetazolamide
• Other Study ID Numbers: 2017-00137G

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No