Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT02450968
Altitude Related Illness In Patients With Respiratory Disease
A Phase 4 study testing Dexamethasone in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Zurich at 1 site in Kyrgyzstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- May 2015to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2
- Living at low altitude (<800m)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site
National Center of Cardiology and Internal Medicine
Bishkek, 720040
About this study
Official title: Dexamethasone for Prophylaxis of Acute Mountain Sickness in Patients With Chronic Obstructive Pulmonary Disease Travelling to Altitude
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.
Read the 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.
- Being tested
- Dexamethasone, Placebo
- Keywords
- airway disease, bronchitis, emphysema, lung, treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Dexamethasone 4 mg capsules, twice per day, orally Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Placebo capsules twice per day, orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day 3 at 3200 m
Secondary outcomes (6)
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.
Measured: day 1 to 3 at 3200m
Acute mountain sickness, severity
Difference between dexamethasone and placebo group in the acute mountain sickness severity assessed by the environmental symptoms questionnaire cerebral subscale
Measured: day 1, day 2, day 3 at 3200 m
6 min walk distance
Difference in the distance walked in 6 min between the dexamethasone and placebo group
Measured: Day 2 at 3200 m
Perceived exertion
Difference in the perceived exertion rated with the Borg CR10 scale between the dexamethasone and placebo group
Measured: Day 2 at 3200 m
Spirometry
Difference in the spirometric variables between the dexamethasone and placebo group
Measured: Day 2 at 3200 m
Arterial blood gases
Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the dexamethasone and placebo group
Measured: Day 2 at 3200 m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Responsible party
- Sponsor
- Investigators
- Konrad E Bloch, MD, Study chair, University Hospital, ZürichTalant M Sooronbaev, MD, Study director, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450968
- Sponsor's protocol ID
- EK15-2015
- Status last verified
- May 2017
- First submitted
- 18 May 2015
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Preiss H, Mayer L, Furian M, Schneider SR, Muller J, Saxer S, Mademilov M, Titz A, Shehab A, Reimann L, Sooronbaev T, Tanner FC, Bloch KE, Ulrich S, Lichtblau M. Right ventricular strain impairment due to hypoxia in patients with COPD: a post hoc analysis of two randomised controlled trials. Open Heart. 2025 Jan 4;12(1):e002837. doi: 10.1136/openhrt-2024-002837.
PubMed 39756820Muralt 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.
PubMed 29988503Furian 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.
PubMed 29909285
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone for Prophylaxis of Acute Mountain Sickness in Patients With Chronic Obstructive Pulmonary Disease Travelling to Altitude
- ClinicalTrials.gov ID
- NCT02450968
- Acronym / sponsor ID
- EK15-2015
- Keywords
- airway disease, bronchitis, emphysema, lung, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneDexamethasone 4 mg capsules, twice per day, orally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules twice per day, orally |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2
- Living at low altitude (<800m)
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone | Drug | Dexamethasone |
| Placebo | Drug | Placebo |
Primary outcome
Acute mountain sickness, cumulative incidence
Time frame: day 3 at 3200 m
Difference between dexamethasone and placebo group in cumulative incidence of acute mountain sickness assessed by the environmental symptoms questionnaire cerebral subscale (score >=0.7)
6 secondary outcomes
Severe hypoxemia
Time frame: day 1 to 3 at 3200m
Acute mountain sickness, severity
Time frame: day 1, day 2, day 3 at 3200 m
6 min walk distance
Time frame: Day 2 at 3200 m
Perceived exertion
Time frame: Day 2 at 3200 m
Spirometry
Time frame: Day 2 at 3200 m
Arterial blood gases
Time frame: Day 2 at 3200 m
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Derived from this study: PubMed 39756820Preiss H, Mayer L, Furian M, Schneider SR, Muller J, Saxer S, Mademilov M, Titz A, Shehab A, Reimann L, Sooronbaev T, Tanner FC, Bloch KE, Ulrich S, Lichtblau M. Right ventricular strain impairment due to hypoxia in patients with COPD: a post hoc analysis of two randomised controlled trials. Open Heart. 2025 Jan 4;12(1):e002837. doi: 10.1136/openhrt-2024-002837.
- Derived from this study: PubMed 29988503Muralt 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.
- Derived from this study: PubMed 29909285Furian 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.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konrad E Bloch, MD study chair
University Hospital, Zürich
Talant M Sooronbaev, MD study director
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Zurich at 1 site in Kyrgyzstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kyrgyzstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute mountain sickness, cumulative incidence (time frame: day 3 at 3200 m). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02450968, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.