Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years

NCT03561675 | Completed Phase 4

• 1 other identifier: 2018-01-8/305
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing acute mountain sickness in lowlanders older than 40 years travelling from 760 m to 3'100 m.

Conditions

Acute Mountain Sickness

Keywords

healthy participants older than 40 years; altitude; prevention; acetazolamide

Outcome Measures

Primary Outcomes (1)

• Acute mountain sickness (AMS), incidence

  Difference between acetazolamide and placebo group in the incidence of AMS during the stay at 3'100 m.

  Day 1 to 3 at 3'100m

Secondary Outcomes (6)

• Acute mountain sickness (AMS), severity assessed by the Lake Louise score

  Day 1 to 3 at 3'100m

• Acute mountain sickness (AMS) at 760 m with and without acetazolamide, severity

  Day 3 at 760 m

• Altitude related adverse health effects (ARAHE), incidence

  Day 1 to 3 at 3'100m

• Spirometric measurement of forced expiratory volume in one second

  Day 2 at 760m and day 2 at 3'100m

• Arterial partical pressure of oxygen

  Day 2 at 760m and day 2 at 3'100m

Study Arms (2)

ACETAZOLAMIDE oral capsule

ACTIVE COMPARATOR

Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m

Drug: ACETAZOLAMIDE oral capsule

PLACEBO oral capsule

PLACEBO COMPARATOR

Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m.

Drug: Placebo oral capsule

Interventions

ACETAZOLAMIDE oral capsule DRUG

Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m

ACETAZOLAMIDE oral capsule

Placebo oral capsule DRUG

Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m

PLACEBO oral capsule

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women, age 40-75 yrs, without any disease and need of medication.
• Born, raised and currently living at low altitude (\<800m).
• Written informed consent.
• Kyrgyz ethnicity

You may not qualify if:

• Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
• Any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol.
• Allergy to acetazolamide and other sulfonamides.

Sponsors & Collaborators

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

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

Related Publications (2)

• Furian M, Mademilov M, Buergin A, Scheiwiller PM, Mayer L, Schneider S, Emilov B, Lichtblau M, Bitos K, Muralt L, Groth A, Reiser AE, Sevik A, Sheraliev U, Marazhapov NH, Aydaralieva S, Muratbekova A, Tabyshova A, Abdraeva A, Buenzli S, Sooronbaev TM, Ulrich S, Bloch KE. Acetazolamide to Prevent Adverse Altitude Effects in COPD and Healthy Adults. NEJM Evid. 2022 Jan;1(1):EVIDoa2100006. doi: 10.1056/EVIDoa2100006. Epub 2021 Dec 22.

  PMID: 38296630 DERIVED

• Graf LC, Furian M, Bitos K, Mademilov M, Abdraeva A, Buenzli J, Buenzli S, Aidaralieva S, Sheraliev U, Mayer LC, Schneider SR, Sooronbaev TM, Ulrich S, Bloch KE. Effect of altitude and acetazolamide on sleep and nocturnal breathing in healthy lowlanders 40 y of age or older. Data from a randomized trial. Sleep. 2023 Apr 12;46(4):zsac269. doi: 10.1093/sleep/zsac269.

  PMID: 36356042 DERIVED

MeSH Terms

Conditions

Altitude Sickness

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Konrad E Bloch, MD

  University Hospital, Zürich

  STUDY CHAIR

• Talant M Sooronbaev, MD

  National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

  STUDY DIRECTOR

• Michael Furian, MSc

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 19, 2018
• Study Start: May 15, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

KY (1)