Acute Mountain SicknessPhase 1ASPIRATENCT03154645
Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy
A Phase 1 study testing Ibuprofen and Acetazolamide in people with Acute Mountain Sickness, run by Grant S Lipman at 1 site in United States.
Trial summary
This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention of acute mountain sickness. These drugs have never been directly compared for efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- Ibuprofen and Acetazolamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2017to 1 Oct 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 healthy non-pregnant volunteer
- Sea-level dwelling (live at low elevation < 4000 ft)
- Arrange your own transportation to WMRS (Bishop) by Friday evening of study weekend
- Available for full study duration (Friday PM-Sunday AM)
Who cannot join
- Age <18 or >65, Pregnant, Live at altitude >4000 ft
- Slept at altitude > 4000ft within 1 week of study
- Allergic to acetazolamide, sulfa drugs, or non-steroidal anti-inflammatories
- Taking NSAIDs, Acetazolamide, or Corticosteroids 1 week prior to study
- Medical History of Brain Tumor, increased brain pressure, pseudotumor cerebri, VP shunts, HACE, or HAPE.
Trial locations and contacts
1 site in 1 country.
United States1 site
White Mountain Research Station
Bishop, California, 93515
About this study
This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention of acute mountain sickness. These drugs have never been directly compared for efficacy. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California.
Read the detailed description
The specific aim of this study is to evaluate if acetazolamide will be similar to ibuprofen (i.e. Ibuprofen being non-inferior) in decreasing the incidence of Acute Mountain Sickness (AMS) in travelers to high altitude. It has been shown that ibuprofen taken 3 times a day 6 hours prior to ascent is effective for the prevention of AMS, with a number needed to treat of 4, decreasing the odds of getting AMS by a third. The efficacy appears to be similar to acetazolamide, with a NNT of 3 -8, although these two medications have not been directly compared in prevention of AMS. Acetazolamide is diuretic that is the only FDA approved AMS prophylactic medication and the most commonly used drug for AMS prevention. Although acetazolamide has been given a 1A indication, it has been shown to limit exercise capabilities at high altitude, and rapid ascent has been shown to attenuate its protective effects. Ibuprofen has been given a IIB recommendation by the Wilderness Medical Society Practice Guidelines, in part because it has not directly compared to acetazolamide. It is unknown if a non-steroidal anti-inflammatory can provide protection from AMS equivalent to acetazolamide.
- Conditions
- Acute Mountain Sickness
- Being tested
- Ibuprofen, Acetazolamide
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Motrin
non-steroidal anti-inflammatory drug
AcetazolamideDrug
Also called diamox
a diuretic
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Active comparator | ibuprofen, 600mg, three times a day, through to ascent to high altitude Receives: Drug: Ibuprofen |
| acetazolamide | Active comparator | acetazolamide, 125mg, two times a day, through to ascent to high altitude Receives: Drug: Acetazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of acute mountain sickness
incidence of acute mountain sickness by Lake Louise Questionnaire
Measured: 2 days
Secondary outcomes (3)
severity of acute mountain sickness
severity of acute mountain sickness by Lake Louise Questionnaire (0-15)
Measured: 2 days
oxygen saturation
measurement of oxygen saturation (%) by fingertip pulse oximetry
Measured: 2 days
Groningen Sleep Quality Questionnaire (GSQQ)
Groningen Sleep Quality Questionnaire (GSQQ) (0-14)
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start12 Aug 2017
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
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
- Model description
- randomized double blind controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grant S Lipman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grant S Lipman, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154645
- Sponsor's protocol ID
- 40325
- Acronym
- ASPIRATE
- Status last verified
- Nov 2018
- First submitted
- 11 May 2017
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burns P, Lipman GS, Warner K, Jurkiewicz C, Phillips C, Sanders L, Soto M, Hackett P. Altitude Sickness Prevention with Ibuprofen Relative to Acetazolamide. Am J Med. 2019 Feb;132(2):247-251. doi: 10.1016/j.amjmed.2018.10.021. Epub 2018 Nov 10.
PubMed 30419226
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy
- ClinicalTrials.gov ID
- NCT03154645
- Acronym / sponsor ID
- ASPIRATE / 40325
- Conditions
- Acute Mountain Sickness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Grant S LipmanUniversity, hospital or other
- Study start
- 12 Aug 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 16 May 2017 (actual)
- 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.
This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention of acute mountain sickness. These drugs have never been directly compared for efficacy. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California.
Detailed description
The specific aim of this study is to evaluate if acetazolamide will be similar to ibuprofen (i.e. Ibuprofen being non-inferior) in decreasing the incidence of Acute Mountain Sickness (AMS) in travelers to high altitude. It has been shown that ibuprofen taken 3 times a day 6 hours prior to ascent is effective for the prevention of AMS, with a number needed to treat of 4, decreasing the odds of getting AMS by a third. The efficacy appears to be similar to acetazolamide, with a NNT of 3 -8, although these two medications have not been directly compared in prevention of AMS. Acetazolamide is diuretic that is the only FDA approved AMS prophylactic medication and the most commonly used drug for AMS prevention. Although acetazolamide has been given a 1A indication, it has been shown to limit exercise capabilities at high altitude, and rapid ascent has been shown to attenuate its protective effects. Ibuprofen has been given a IIB recommendation by the Wilderness Medical Society Practice Guidelines, in part because it has not directly compared to acetazolamide. It is unknown if a non-steroidal anti-inflammatory can provide protection from AMS equivalent to acetazolamide.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blind controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Active comparator | Drug: Ibuprofenibuprofen, 600mg, three times a day, through to ascent to high altitude |
| acetazolamide | Active comparator | Drug: Acetazolamideacetazolamide, 125mg, two times a day, through to ascent to high altitude |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 healthy non-pregnant volunteer
- Sea-level dwelling (live at low elevation < 4000 ft)
- Arrange your own transportation to WMRS (Bishop) by Friday evening of study weekend
- Available for full study duration (Friday PM-Sunday AM)
Key exclusion criteria (5 listed)
- Age <18 or >65, Pregnant, Live at altitude >4000 ft
- Slept at altitude > 4000ft within 1 week of study
- Allergic to acetazolamide, sulfa drugs, or non-steroidal anti-inflammatories
- Taking NSAIDs, Acetazolamide, or Corticosteroids 1 week prior to study
- Medical History of Brain Tumor, increased brain pressure, pseudotumor cerebri, VP shunts, HACE, or HAPE.
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 |
|---|---|---|
| IbuprofenAlso: Motrinnon-steroidal anti-inflammatory drug | Drug | Ibuprofen |
| AcetazolamideAlso: diamoxa diuretic | Drug | acetazolamide |
Primary outcome
incidence of acute mountain sickness
Time frame: 2 days
incidence of acute mountain sickness by Lake Louise Questionnaire
3 secondary outcomes
severity of acute mountain sickness
Time frame: 2 days
oxygen saturation
Time frame: 2 days
Groningen Sleep Quality Questionnaire (GSQQ)
Time frame: 2 days
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 26 Nov 2018.
- Results publication: PubMed 30419226Burns P, Lipman GS, Warner K, Jurkiewicz C, Phillips C, Sanders L, Soto M, Hackett P. Altitude Sickness Prevention with Ibuprofen Relative to Acetazolamide. Am J Med. 2019 Feb;132(2):247-251. doi: 10.1016/j.amjmed.2018.10.021. Epub 2018 Nov 10.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ibuprofen and Acetazolamide in people with Acute Mountain Sickness, run by Grant S Lipman at 1 site in United States.
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 4 inclusion and 5 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 26 Nov 2018. 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 United States. 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. 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: 2 days). 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 NCT03154645, 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 26 Nov 2018.