High Altitude Pulmonary EdemaPhase 4NCT03490916
Effect of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography
A Phase 4 study testing Acetazolamide in people with High Altitude Pulmonary Edema, run by Vincent Kan at 1 site in United States.
Trial summary
The overall goal of this study is to detect preclinical signs of HAPE by lung ultrasonography and evaluate the effectiveness of acetazolamide at decreasing pulmonary edema by using ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Altitude Pulmonary Edema
- What is being tested?
- Acetazolamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2018to 4 Apr 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Able to consent
- English speaking
- Trekking directly to Everest Base Camp
Who cannot join
- Age less than 18 years
- Non-English speaking
- Pregnant
- Already had a diagnosis of acute mountain sickness, high-altitude cerebral edema, or high-altitude pulmonary edema
- Been on a high-altitude trek 2 weeks prior to this study
- Has taken acetazolamide 1 week prior to start of trek
- Has a sulfa allergy
- Has any type of acute or chronic pulmonary conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School
Worcester, Massachusetts, 01655
About this study
Official title: A Prospective, Double-blind, Randomized, Placebo-controlled Trial of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography
The overall goal of this study is to detect preclinical signs of HAPE by lung ultrasonography and evaluate the effectiveness of acetazolamide at decreasing pulmonary edema by using ultrasound.
- Conditions
- High Altitude Pulmonary Edema
- Being tested
- Acetazolamide, Placebo
- Keywords
- Acetazolamide, High-altitude illness, High-altitude pulmonary edema, Lung comets, Lung ultrasound, Subclinical high-altitude pulmonary edema
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called diamox
Administration of Acetazolamide
PlaceboDrug
Administration of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide normal dose | Experimental | One (1) dose of 250mg of Acetazolamide Receives: Drug: Acetazolamide |
| Placebo | Placebo comparator | One (1) dose of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Edema Before and After Taking Acetazolamide
Edema measured through ultrasound exam
Measured: 1 month
Secondary outcomes (1)
Time to Completion of Ultrasound Exams
Time it takes to complete ultrasound exams
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start23 Mar 2018
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
Why it stopped: PI was unable to continue to gather data during the trip during to medical illness
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for High Altitude Pulmonary EdemaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vincent Kan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vincent Kan, University of Massachusetts, Worcester
- Investigators
- Hillary Irons, MD, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490916
- Sponsor's protocol ID
- H00014860
- Status last verified
- Apr 2019
- First submitted
- 30 Mar 2018
- Last updated
- 10 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No ipd to share.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Randomized, Placebo-controlled Trial of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography
- ClinicalTrials.gov ID
- NCT03490916
- Acronym / sponsor ID
- H00014860
- Conditions
- High Altitude Pulmonary Edema
- Keywords
- Acetazolamide, High-altitude illness, High-altitude pulmonary edema, Lung comets, Lung ultrasound, Subclinical high-altitude pulmonary edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI was unable to continue to gather data during the trip during to medical illness
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vincent KanUniversity, hospital or other
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Posted 10 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to detect preclinical signs of HAPE by lung ultrasonography and evaluate the effectiveness of acetazolamide at decreasing pulmonary edema by using ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide normal dose | Experimental | Drug: AcetazolamideOne (1) dose of 250mg of Acetazolamide |
| Placebo | Placebo comparator | Drug: PlaceboOne (1) dose of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Able to consent
- English speaking
- Trekking directly to Everest Base Camp
Key exclusion criteria (8 listed)
- Age less than 18 years
- Non-English speaking
- Pregnant
- Already had a diagnosis of acute mountain sickness, high-altitude cerebral edema, or high-altitude pulmonary edema
- Been on a high-altitude trek 2 weeks prior to this study
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 |
|---|---|---|
| AcetazolamideAlso: diamoxAdministration of Acetazolamide | Drug | Acetazolamide normal dose |
| PlaceboAdministration of Placebo | Drug | Placebo |
Primary outcome
Pulmonary Edema Before and After Taking Acetazolamide
Time frame: 1 month
Edema measured through ultrasound exam
1 secondary outcome
Time to Completion of Ultrasound Exams
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No ipd to share.
Related trials for High Altitude Pulmonary Edema
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High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Children High-altitude Pulmonary Edema
High-altitude Pulmonary Edema
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Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease at High Altitude
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Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
High Altitude, Healthy Adult
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Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals
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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.
Hillary Irons, MD, PhD principal investigator
University of Massachusetts, Worcester
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 Acetazolamide in people with High Altitude Pulmonary Edema, run by Vincent Kan 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 8 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: stopped early, as of the sponsor's last update on 10 May 2019. 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. 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?
Yes. Results are posted in the registry (first posted 10 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pulmonary Edema Before and After Taking Acetazolamide (time frame: 1 month). 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 10 May 2019.