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Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Respiratory Disease at Altitude

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ClinicalTrials.gov Identifier: NCT03177850
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances at altitude in patients with COPD.

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

Detailed Description:

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances 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 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

Sleep related breathing disturbances will be evaluated by respiratory polygraphy.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease at Altitude, Assessed by Respiratory Polygraphy: A Randomized, Placebo-controlled, Double-blind Parallel Trial
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : August 2, 2018
Actual Study Completion Date : August 2, 2018

Resource links provided by the National Library of Medicine


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. Change in nocturnal oxygen saturation [ Time Frame: night 1 at 760m and night 1 at 3200 m ]
    Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group

  2. Change in nocturnal oxygen desaturation index [ Time Frame: night 1 at 760m and night 1 at 3200 m ]
    Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group


Secondary Outcome Measures :
  1. Change in nocturnal oxygen saturation [ Time Frame: night 1 at 760m and night 2 at 3200 m ]
    Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group

  2. Change in nocturnal oxygen desaturation index [ Time Frame: night 1 at 760m and night 2 at 3200 m ]
    Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group

  3. Change in apnea/hypopnea index [ Time Frame: night 1 at 760m and night 1 at 3200 m ]
    Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group

  4. Change in apnea/hypopnea index [ Time Frame: night 1 at 760m and night 2 at 3200 m ]
    Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group

  5. Change in subjective sleepiness and sleep quality [ Time Frame: Day 1 and 2 at 760m and 3200m ]
    Difference in altitude-induced change in subjective sleepiness and sleep quality assessed by a visual analog scale between acetazolamide and placebo group



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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): NCT03177850


Locations
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Kyrgyzstan
National Center of Cardiology and Internal Medicine
Bishkek, Kyrgyzstan, 720040
Sponsors and Collaborators
University of Zurich
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Investigators
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Study Chair: Konrad E Bloch, MD University of Zurich
Study Director: Talant M Sooronbaev, MD National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03177850     History of Changes
Other Study ID Numbers: 2017-00137D
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
sleep related breathing disturbances
respiratory polygraphy
airway disease
emphysema
acetazolamide
altitude
nocturnal pulse oxymetry
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs