Altitude SicknessPhase 3NCT02941510
Inhaled Budesonide for Altitude Illness Prevention
A Phase 3 study testing Budesonide in people with Altitude Sickness, run by University of Colorado, Denver.
Trial summary
A randomized, double-blinded study administering budesonide, a medication to reduce inflammation in the lungs, to healthy volunteers to examine effects on altitude illness prevention by spending 18 hours overnight at 14,000 ft elevation. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Altitude Sickness
- What is being tested?
- Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2017to 6 Mar 2017
- Phase
- Phase 3
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy, altitude naive, 21-40 years old
Who cannot join
- smokers
- pregnancy
- hx of asthma
- current inhaled steroid use
- those with diseases or disorders known to be affected by hypoxia or the drugs used in this study such as
- migraine or other chronic headaches,
Show all 14Show fewer
- sickle cell trait or disease, or
- diabetes
- history of significant head injury or seizures
- taking any medication (over-the-counter or prescription) or herbal supplements
- a known hypersensitivity reaction to budesonide
- inability to be headache-free when consuming the amount of caffeine in two six ounce cups of coffee or less per day
- exposure to high altitude above 2000m in the previous 1 month or
- those who have been on an airline flight over six hours (Airplane cabins are pressurized to an elevation that can approximate exposure to high altitude)
About this study
A randomized, double-blinded study administering budesonide, a medication to reduce inflammation in the lungs, to healthy volunteers to examine effects on altitude illness prevention by spending 18 hours overnight at 14,000 ft elevation.
Read the detailed description
A randomized, double-blinded study will be conducted to validate the results of previous literature on the use of budesonide in the prevention of altitude sickness. It will be conducted using healthy participants overseen by experienced wilderness medicine and altitude researchers from the Altitude Research Center at University of Colorado Denver. Participants will be recruited from the Denver community and prescreened for eligibility via phone. 100 participants, after consenting, will have baseline data and blood collected and will begin budesonide therapy 72 hours prior to being taken from Denver to Pikes Peak, where they will be observed at altitude for 18 hours. Patients will have the opportunity to withdraw consent at any time and will be monitored continuously by physician-researchers. Data collection and blood draws will be performed at specific time points and analyzed for efficacy of budesonide vs. placebo in the incidence of altitude sickness.
- Conditions
- Altitude Sickness
- Being tested
- Budesonide, Placebo
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Budesonide is FDA approved for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). It works by reducing lung inflammation to increase oxygen uptake by the body. The researchers are examining if this medication can prevent altitude sickness.
PlaceboOther
Subject(s) will participate in all study activities but will receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Experimental | Will participate in all study activities but will receive budesonide. Receives: Drug: Budesonide |
| Placebo | Placebo comparator | Will participate in all study activities but will receive placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Inflammation
Analysis to compare activity in pro-inflammatory pathways and activity in anti-permeability pathways, as measured by serum markers, between budesonide and placebo.
Measured: During 18 hours at elevation compared to baseline.
Incidence of Acute Mountain Sickness (AMS)
Comparison of incidence and severity of acute mountain sickness between budesonide and placebo.
Measured: During 18 hours at elevation compared to baseline.
Changes in Gene regulation
Comparison of gene regulation involved in acclimatization and altitude illness.
Measured: During 18 hours at elevation compared to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start6 Mar 2017
- Primary completion6 Mar 2017
- Study completion6 Mar 2017
Why it stopped: Stopped prior to enrollment per PI and DSMB decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Altitude SicknessStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Paterson, MD, DiMM, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941510
- Sponsor's protocol ID
- 16-2184
- Status last verified
- Mar 2017
- First submitted
- 19 Oct 2016
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Budesonide for Altitude Illness Prevention
- ClinicalTrials.gov ID
- NCT02941510
- Acronym / sponsor ID
- 16-2184
- Conditions
- Altitude Sickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stopped prior to enrollment per PI and DSMB decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 6 Mar 2017 (actual)
- First posted
- 21 Oct 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.
A randomized, double-blinded study administering budesonide, a medication to reduce inflammation in the lungs, to healthy volunteers to examine effects on altitude illness prevention by spending 18 hours overnight at 14,000 ft elevation.
Detailed description
A randomized, double-blinded study will be conducted to validate the results of previous literature on the use of budesonide in the prevention of altitude sickness. It will be conducted using healthy participants overseen by experienced wilderness medicine and altitude researchers from the Altitude Research Center at University of Colorado Denver. Participants will be recruited from the Denver community and prescreened for eligibility via phone. 100 participants, after consenting, will have baseline data and blood collected and will begin budesonide therapy 72 hours prior to being taken from Denver to Pikes Peak, where they will be observed at altitude for 18 hours. Patients will have the opportunity to withdraw consent at any time and will be monitored continuously by physician-researchers. Data collection and blood draws will be performed at specific time points and analyzed for efficacy of budesonide vs. placebo in the incidence of altitude sickness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Experimental | Drug: BudesonideWill participate in all study activities but will receive budesonide. |
| Placebo | Placebo comparator | Other: PlaceboWill participate in all study activities but will receive placebo. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy, altitude naive, 21-40 years old
Key exclusion criteria (14 listed)
- smokers
- pregnancy
- hx of asthma
- current inhaled steroid use
- those with diseases or disorders known to be affected by hypoxia or the drugs used in this study such as
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 |
|---|---|---|
| BudesonideBudesonide is FDA approved for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). It works by reducing lung inflammation to increase oxygen uptake by the body. The researchers are examining if this medication can prevent altitude sickness. | Drug | Budesonide |
| PlaceboSubject(s) will participate in all study activities but will receive placebo. | Other | Placebo |
Primary outcome
Changes in Inflammation
Time frame: During 18 hours at elevation compared to baseline.
Analysis to compare activity in pro-inflammatory pathways and activity in anti-permeability pathways, as measured by serum markers, between budesonide and placebo.
Incidence of Acute Mountain Sickness (AMS)
Time frame: During 18 hours at elevation compared to baseline.
Comparison of incidence and severity of acute mountain sickness between budesonide and placebo.
Changes in Gene regulation
Time frame: During 18 hours at elevation compared to baseline.
Comparison of gene regulation involved in acclimatization and altitude illness.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- 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.
Ryan Paterson, MD, DiMM principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide in people with Altitude Sickness, run by University of Colorado, Denver.
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 1 inclusion and 14 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: withdrawn, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in Inflammation (time frame: During 18 hours at elevation compared to baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2017.