Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT02450994
Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude
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 sleep related breathing disturbances 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 Sep 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 Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease (COPD) Travelling to Altitude
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.
Read the detailed description
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
- Being tested
- Dexamethasone, Placebo
- Keywords
- airway disease, bronchitis, emphysema, lung, treatment, sleep
- 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.
Mean nocturnal oxygen saturation measured by pulse oximetry
Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group
Measured: night 1 at 3200 m
Secondary outcomes (11)
Oxygen desaturation index
Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group
Measured: night 1 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group
Measured: night 2 at 3200 m
Apnea/hypopnea index
Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group
Measured: night 2 at 3200 m
Apnea/hypopnea index
Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group
Measured: night 1 at 3200 m
Oxygen desaturation index
Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group
Measured: night 2 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group
Measured: night 1 at 700 m
Oxygen desaturation index
Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group
Measured: night 1 at 700 m
Apnea/hypopnea index
Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group
Measured: night 1 at 700 m
Psychomotor vigilance test reaction time
Difference in reaction time during psychomotor vigilance test between dexamethasone and placebo group
Measured: day 2 at 700 m
Subjective sleepiness
Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group
Measured: day 2 at 700 m
Subjective sleepiness
Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between 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 completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 (actual)
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
- NCT02450994
- Sponsor's protocol ID
- EK15-2015_V1
- Status last verified
- Dec 2015
- First submitted
- 18 May 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30794302
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone for Prophylaxis of Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease (COPD) Travelling to Altitude
- ClinicalTrials.gov ID
- NCT02450994
- Acronym / sponsor ID
- EK15-2015_V1
- Keywords
- airway disease, bronchitis, emphysema, lung, treatment, sleep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- 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
- Sep 2015 (actual)
- Study completion
- Sep 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 sleep related breathing disturbances 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 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
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
Mean nocturnal oxygen saturation measured by pulse oximetry
Time frame: night 1 at 3200 m
Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group
11 secondary outcomes
Oxygen desaturation index
Time frame: night 1 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Time frame: night 2 at 3200 m
Apnea/hypopnea index
Time frame: night 2 at 3200 m
Apnea/hypopnea index
Time frame: night 1 at 3200 m
Oxygen desaturation index
Time frame: night 2 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Time frame: night 1 at 700 m
Oxygen desaturation index
Time frame: night 1 at 700 m
Apnea/hypopnea index
Time frame: night 1 at 700 m
Psychomotor vigilance test reaction time
Time frame: day 2 at 700 m
Subjective sleepiness
Time frame: day 2 at 700 m
Subjective sleepiness
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 21 Dec 2015.
- Derived from this study: PubMed 30794302Furian 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.
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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 21 Dec 2015. 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?
Mean nocturnal oxygen saturation measured by pulse oximetry (time frame: night 1 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 NCT02450994, which also lists 1 linked publication.
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 21 Dec 2015.