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Altitude Related Illness In Patients With Respiratory Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 4

Locations

Kyrgyzstan

Study Type

Interventional

Intervention

Dexamethasone

Placebo

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring airway disease, bronchitis, emphysema, lung, treatment

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2
Living at low altitude (<800m)

Exclusion Criteria:

COPD exacerbation
severe COPD, GOLD grade 3 or 4
arterial oxygen saturation <92% at low altitude (<800 m)
Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea.
Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day).
pregnant or nursing patients

Sites / Locations

National Center of Cardiology and Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

Dexamethasone 4 mg capsules, twice per day, orally

Placebo capsules twice per day, orally

Outcomes

Primary Outcome Measures

Acute mountain sickness, cumulative incidence

Difference between dexamethasone and placebo group in cumulative incidence of acute mountain sickness assessed by the environmental symptoms questionnaire cerebral subscale (score >=0.7)

Secondary Outcome Measures

Severe hypoxemia

Number of participants in the dexamethasone and placebo group with arterial oxygen saturation measured by pulse oximetry less than 75% for more than 30 min or less than 70% for more than 15 min.

Acute mountain sickness, severity

Difference between dexamethasone and placebo group in the acute mountain sickness severity assessed by the environmental symptoms questionnaire cerebral subscale

6 min walk distance

Difference in the distance walked in 6 min between the dexamethasone and placebo group

Perceived exertion

Difference in the perceived exertion rated with the Borg CR10 scale between the dexamethasone and placebo group

Spirometry

Difference in the spirometric variables between the dexamethasone and placebo group

Arterial blood gases

Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the dexamethasone and placebo group

Full Information

NCT ID

NCT02450968

First Posted

May 18, 2015

Last Updated

May 16, 2017

Sponsor

University of Zurich

Collaborators

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

1. Study Identification

Unique Protocol Identification Number

NCT02450968

Brief Title

Altitude Related Illness In Patients With Respiratory Disease

Official Title

Dexamethasone for Prophylaxis of Acute Mountain Sickness in Patients With Chronic Obstructive Pulmonary Disease Travelling to Altitude

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

Collaborators

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing acute mountain sickness in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.

Detailed Description

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of dexamethasone prophylaxis in reducing the incidence of acute mountain sickness in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (700m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Dexamethasone 2x4mg/day (or placebo), will be administered before departure at 700 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

airway disease, bronchitis, emphysema, lung, treatment

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone

Arm Type

Active Comparator

Arm Description

Dexamethasone 4 mg capsules, twice per day, orally

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo capsules twice per day, orally

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Acute mountain sickness, cumulative incidence

Description

Difference between dexamethasone and placebo group in cumulative incidence of acute mountain sickness assessed by the environmental symptoms questionnaire cerebral subscale (score >=0.7)

Time Frame

day 3 at 3200 m

Secondary Outcome Measure Information:

Title

Severe hypoxemia

Description

Number of participants in the dexamethasone and placebo group with arterial oxygen saturation measured by pulse oximetry less than 75% for more than 30 min or less than 70% for more than 15 min.

Time Frame

day 1 to 3 at 3200m

Title

Acute mountain sickness, severity

Description

Difference between dexamethasone and placebo group in the acute mountain sickness severity assessed by the environmental symptoms questionnaire cerebral subscale

Time Frame

day 1, day 2, day 3 at 3200 m

Title

6 min walk distance

Description

Difference in the distance walked in 6 min between the dexamethasone and placebo group

Time Frame

Day 2 at 3200 m

Title

Perceived exertion

Description

Difference in the perceived exertion rated with the Borg CR10 scale between the dexamethasone and placebo group

Time Frame

Day 2 at 3200 m

Title

Spirometry

Description

Difference in the spirometric variables between the dexamethasone and placebo group

Time Frame

Day 2 at 3200 m

Title

Arterial blood gases

Description

Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the dexamethasone and placebo group

Time Frame

Day 2 at 3200 m

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2 Living at low altitude (<800m) Exclusion Criteria: COPD exacerbation severe COPD, GOLD grade 3 or 4 arterial oxygen saturation <92% at low altitude (<800 m) Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea. Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day). pregnant or nursing patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Konrad E Bloch, MD

Organizational Affiliation

University Hospital, Zürich

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Talant M Sooronbaev, MD

Organizational Affiliation

National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Official's Role

Study Director

Facility Information:

Facility Name

National Center of Cardiology and Internal Medicine

City

Bishkek

ZIP/Postal Code

720040

Country

Kyrgyzstan

12. IPD Sharing Statement

Citations:

PubMed Identifier

29988503

Citation

Muralt L, Furian M, Lichtblau M, Aeschbacher SS, Clark RA, Estebesova B, Sheraliev U, Marazhapov N, Osmonov B, Bisang M, Ulrich S, Latshang TD, Ulrich S, Sooronbaev TM, Bloch KE. Postural Control in Lowlanders With COPD Traveling to 3100 m: Data From a Randomized Trial Evaluating the Effect of Preventive Dexamethasone Treatment. Front Physiol. 2018 Jun 22;9:752. doi: 10.3389/fphys.2018.00752. eCollection 2018.

Results Reference

derived

PubMed Identifier

29909285

Citation

Furian M, Lichtblau M, Aeschbacher SS, Estebesova B, Emilov B, Sheraliev U, Marazhapov NH, Mademilov M, Osmonov B, Bisang M, Ulrich S, Latshang TD, Ulrich S, Sooronbaev TM, Bloch KE. Efficacy of Dexamethasone in Preventing Acute Mountain Sickness in COPD Patients: Randomized Trial. Chest. 2018 Oct;154(4):788-797. doi: 10.1016/j.chest.2018.06.006. Epub 2018 Jul 10.

Results Reference

derived

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Altitude Related Illness In Patients With Respiratory Disease

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