Acute Mountain SicknessPhase 1NCT02811016
Inhaled Budesonide and Acute Mountain Sickness
A Phase 1 study testing Budesonide 200 and Budesonide 800 in people with Acute Mountain Sickness, run by Salzburger Landeskliniken at 1 site in Austria.
Trial summary
The primary objective of the study is to investigate the effect of inhaled budesonide on the incidence of AMS. The primary study question to ask is: 1. Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559 m? In addition, the secondary study questions to ask are: 1. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- Budesonide 200 and Budesonide 800
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2016to Oct 2016
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good physical condition
- No relevant pathologies revealed by the pre-investigation prior to the study
- Written informed consent to participate in the study
- Permanent residency below 1000 m
- Males and females are included without prioritization
Who cannot join
- Acute and chronic lung diseases
- Conventional systolic blood pressure (average of two measurements) ≥150 mmHg and conventional diastolic blood pressure ≥95 mmHg in untreated or treated subjects
- Cardiovascular diseases other than hypertension (coronary heart disease, heart failure, atrial fibrillation, peripheral artery disease)
- Chronic headache / migraine
- Diabetes mellitus
- Smoking (>6 cigarettes/day) or equivalent nicotine substitutes
Show all 12Show fewer
- Alcohol (>30 g/d) or drug abuse
- Obesity (Body Mass Index >30)
- Other conditions deemed relevant by the investigator (including liver disease, renal disease)
- Sojourn >2000 m within the last 4 weeks before the 1st study day
- Drug intake within the last 2 moth before the 1st study day if the drug intake could affect the data quality or the safety of the participants
- Blood donation within the last 2 month before the 1st study day
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Anesthesiology, University Hospital
Salzburg, State of Salzburg, 5020
About this study
Official title: Effect of Inhaled Budesonide on the Incidence and Severity of Acute Mountain Sickness at 4559 m
The primary objective of the study is to investigate the effect of inhaled budesonide on the incidence of AMS. The primary study question to ask is:
- Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559 m?
Read more
In addition, the secondary study questions to ask are:
- Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m?
- Are the effects of inhaled budesonide on AMS incidence and severity related to its plasma concentration?
Study medication Inhaled budesonide at 2 different concentrations (2 x 200 µg, 2 x 800 µg) versus placebo
Study design
- Prospective, controlled, single-center study on 51 healthy volunteers at 4559 m [Capanna Regina Margherita (Margherita Hut), Italy]
- With regard to the intervention (inhaled budesonide) double-blinded and randomized
Read the detailed description
Primary objective
The primary objective of the study is to investigate the effect of inhaled budesonide on the incidence of AMS. The primary study question to ask is:
- Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559 m?
In addition, the secondary study questions to ask are:
- Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m?
- Are the effects of inhaled budesonide on AMS incidence and severity related to its plasma concentration?
Study medication Inhaled budesonide at 2 different concentrations (2 x 200 µg, 2 x 800 µg) versus placebo
Study design Prospective, controlled, single-center study on 51 healthy volunteers at 4559 m [Capanna Regina Margherita (Margherita Hut), Italy] With regard to the intervention (inhaled budensoide) double-blinded and randomized
Study population 51 healthy volunteers
Study site Prior to the study the pre-investigations will be performed at the University Hospital Salzburg, Austria. The high-altitude part will take place at the Capanna Regina Margherita (Margherita Hut, Italy) at 4559 m.
Interventions and investigations
- Ascend from Alagna (1130 m, Italy) to the Margherita Hut (4559 m) in less than 24 h, with a preceding overnight stay at 3611 m (Gnifetti Hut, Italy).
- Stay at the Margherita Hut for 48 hours
- Randomized inhalation of budesonide at two different concentrations (2 x 200 µg 2 x 800 µg, respectively) or placebo
- Assessment of incidence and severity of acute mountain sickness by use of 2 internationally standardized and well established questionnaires
- Venous (and capillary) blood drawings
- Pulmonary function tests
- Transthoracic echocardiography for assessing pulmonary artery systolic pressure
Number and volume of blood drawings For the study venous blood samples (volume: 20 ml each) will be drawn at 5 different time points (5 x 20 ml = 100 ml). Together with the blood drawing for the pre-investigation (20 ml) a total blood volume of 120 ml will be taken. At the same time points capillary blood samples (1 ml) will be taken from the ear lobe for blood gas analyses (5 x 1 ml = 5 ml in total).
Observational period The study will only start after approval by the ethic committee responsible for the study (ethic committee of the Paracelsus Medical University). If the study is approved it will be performed in July 2016.
- Conditions
- Acute Mountain Sickness
- Being tested
- Budesonide 200, Budesonide 800, Placebo
- Keywords
- High Altitude, budesonide, hypoxia
- Medical subject headings
- Altitude Sickness, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide 200Drug
Also called Pulmicort Turbohaler
200 µg inhaled at 7:00 a.m. and 7 p.m.
Budesonide 800Drug
Also called Pulmicort Turbohaler
800 µg inhaled at 7:00 a.m. and 7 p.m.
PlaceboDrug
Also called Lactose-Monohydrate
Placebo Inhalation at 7:00 a.m. and 7 p.m.
| Study group | Role | What they receive |
|---|---|---|
| budesonide 200 | Experimental | inhaled budesonide 200 µg bid Receives: Drug: Budesonide 200 |
| budesonide 800 | Experimental | inhaled budesonide 800 µg bid Receives: Drug: Budesonide 800 |
| placebo | Placebo comparator | inhaled placebo bid Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute mountain sickness
AMS scores positive
Measured: 48 hrs at 4559 m
Secondary outcomes (1)
Severity of acute mountain sickness
Height of AMS scores
Measured: 48 hrs at 4559 m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2016
- Study completionOct 2016
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 Acute Mountain SicknessStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salzburger Landeskliniken
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg
- Responsible party
- Principal investigator, Marc Berger, Salzburger Landeskliniken
- Investigators
- Marc M Berger, MD, Principal investigator, Department of Anesthesiology, University Hospital Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811016
- Sponsor's protocol ID
- M2016
- Status last verified
- Oct 2016
- First submitted
- 14 Jun 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Berger MM, Macholz F, Sareban M, Schmidt P, Fried S, Dankl D, Niebauer J, Bartsch P, Mairbaurl H. Inhaled budesonide does not prevent acute mountain sickness after rapid ascent to 4559 m. Eur Respir J. 2017 Sep 10;50(3):1700982. doi: 10.1183/13993003.00982-2017. Print 2017 Sep. No abstract available.
PubMed 28890439
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inhaled Budesonide on the Incidence and Severity of Acute Mountain Sickness at 4559 m
- ClinicalTrials.gov ID
- NCT02811016
- Acronym / sponsor ID
- M2016
- Conditions
- Acute Mountain Sickness
- Keywords
- High Altitude, budesonide, hypoxia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Salzburger LandesklinikenUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg
- Study start
- Jun 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Jun 2016 (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.
The primary objective of the study is to investigate the effect of inhaled budesonide on the incidence of AMS. The primary study question to ask is:
- Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559 m?
In addition, the secondary study questions to ask are:
- Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m?
- Are the effects of inhaled budesonide on AMS incidence and severity related to its plasma concentration?
Study medication Inhaled budesonide at 2 different concentrations (2 x 200 µg, 2 x 800 µg) versus placebo
Study design
- Prospective, controlled, single-center study on 51 healthy volunteers at 4559 m [Capanna Regina Margherita (Margherita Hut), Italy]
- With regard to the intervention (inhaled budesonide) double-blinded and randomized
Detailed description
Primary objective
The primary objective of the study is to investigate the effect of inhaled budesonide on the incidence of AMS. The primary study question to ask is:
- Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559 m?
In addition, the secondary study questions to ask are:
- Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m?
- Are the effects of inhaled budesonide on AMS incidence and severity related to its plasma concentration?
Study medication Inhaled budesonide at 2 different concentrations (2 x 200 µg, 2 x 800 µg) versus placebo
Study design Prospective, controlled, single-center study on 51 healthy volunteers at 4559 m [Capanna Regina Margherita (Margherita Hut), Italy] With regard to the intervention (inhaled budensoide) double-blinded and randomized
Study population 51 healthy volunteers
Study site Prior to the study the pre-investigations will be performed at the University Hospital Salzburg, Austria. The high-altitude part will take place at the Capanna Regina Margherita (Margherita Hut, Italy) at 4559 m.
Interventions and investigations
- Ascend from Alagna (1130 m, Italy) to the Margherita Hut (4559 m) in less than 24 h, with a preceding overnight stay at 3611 m (Gnifetti Hut, Italy).
- Stay at the Margherita Hut for 48 hours
- Randomized inhalation of budesonide at two different concentrations (2 x 200 µg 2 x 800 µg, respectively) or placebo
- Assessment of incidence and severity of acute mountain sickness by use of 2 internationally standardized and well established questionnaires
- Venous (and capillary) blood drawings
- Pulmonary function tests
- Transthoracic echocardiography for assessing pulmonary artery systolic pressure
Number and volume of blood drawings For the study venous blood samples (volume: 20 ml each) will be drawn at 5 different time points (5 x 20 ml = 100 ml). Together with the blood drawing for the pre-investigation (20 ml) a total blood volume of 120 ml will be taken. At the same time points capillary blood samples (1 ml) will be taken from the ear lobe for blood gas analyses (5 x 1 ml = 5 ml in total).
Observational period The study will only start after approval by the ethic committee responsible for the study (ethic committee of the Paracelsus Medical University). If the study is approved it will be performed in July 2016.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| budesonide 200 | Experimental | Drug: Budesonide 200inhaled budesonide 200 µg bid |
| budesonide 800 | Experimental | Drug: Budesonide 800inhaled budesonide 800 µg bid |
| placebo | Placebo comparator | Drug: Placeboinhaled placebo bid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Good physical condition
- No relevant pathologies revealed by the pre-investigation prior to the study
- Written informed consent to participate in the study
- Permanent residency below 1000 m
- Males and females are included without prioritization
Key exclusion criteria (12 listed)
- Acute and chronic lung diseases
- Conventional systolic blood pressure (average of two measurements) ≥150 mmHg and conventional diastolic blood pressure ≥95 mmHg in untreated or treated subjects
- Cardiovascular diseases other than hypertension (coronary heart disease, heart failure, atrial fibrillation, peripheral artery disease)
- Chronic headache / migraine
- Diabetes mellitus
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 |
|---|---|---|
| Budesonide 200Also: Pulmicort Turbohaler200 µg inhaled at 7:00 a.m. and 7 p.m. | Drug | budesonide 200 |
| Budesonide 800Also: Pulmicort Turbohaler800 µg inhaled at 7:00 a.m. and 7 p.m. | Drug | budesonide 800 |
| PlaceboAlso: Lactose-MonohydratePlacebo Inhalation at 7:00 a.m. and 7 p.m. | Drug | placebo |
Primary outcome
Incidence of acute mountain sickness
Time frame: 48 hrs at 4559 m
AMS scores positive
1 secondary outcome
Severity of acute mountain sickness
Time frame: 48 hrs at 4559 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 14 Oct 2016.
- Derived from this study: PubMed 28890439Berger MM, Macholz F, Sareban M, Schmidt P, Fried S, Dankl D, Niebauer J, Bartsch P, Mairbaurl H. Inhaled budesonide does not prevent acute mountain sickness after rapid ascent to 4559 m. Eur Respir J. 2017 Sep 10;50(3):1700982. doi: 10.1183/13993003.00982-2017. Print 2017 Sep. No abstract available.
- Individual participant dataSharing planned: No
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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.
Marc M Berger, MD principal investigator
Department of Anesthesiology, University Hospital Salzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Budesonide 200 and Budesonide 800 in people with Acute Mountain Sickness, run by Salzburger Landeskliniken at 1 site in Austria.
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 5 inclusion and 12 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 14 Oct 2016. 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 Austria. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of acute mountain sickness (time frame: 48 hrs at 4559 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 NCT02811016, 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 14 Oct 2016.