MedDataX Logo

Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude

NCT ID: NCT02450994

Last Updated: 2015-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing sleep related breathing disturbances in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of dexamethasone prophylaxis in sleep related breathing disturbances 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

airway disease bronchitis emphysema lung treatment sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dexamethasone

Dexamethasone 4 mg capsules, twice per day, orally

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Placebo

Placebo capsules twice per day, orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER_GOV

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Konrad E Bloch, MD

Role: STUDY_CHAIR

University Hospital, Zürich

Talant M Sooronbaev, MD

Role: STUDY_DIRECTOR

National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Center of Cardiology and Internal Medicine

Bishkek, , Kyrgyzstan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Kyrgyzstan

References

Explore related publications, articles, or registry entries linked to this study.

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. Effect of Dexamethasone on Nocturnal Oxygenation in Lowlanders With Chronic Obstructive Pulmonary Disease Traveling to 3100 Meters: A Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190067. doi: 10.1001/jamanetworkopen.2019.0067.

Reference Type DERIVED
PMID: 30794302 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EK15-2015_V1

Identifier Type: -

Identifier Source: org_study_id