Phase 2
N=41
Rapid Acclimatization to Hypoxia at Altitude
Physiological Function in Low Oxygen Environment
Bottom Line
View on ClinicalTrials.gov: NCT01702025 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen). — 22.3; 25.2; 22.2; 24.0 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Aminophylline (Drug); Methazolamide (Drug); Aminophylline+Methazolamide (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colorado State University
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen). |
22.3; 25.2; 22.2; 24.0; 23.0; 24.6 | — |
Summary
In low oxygen environments, such as altitude, some adults may become ill and suffer from acute mountain sickness. Further, all adults will find that exercising becomes much more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of this investigation is to study the effects of two drugs that may help people adjust to high-altitude quickly, prevent them from becoming ill and improve their exercise performance. The drugs are Methazolamide and Aminophylline.
Eligibility Criteria
Inclusion Criteria
- normotensive (i.e. <140/90 mmHg)
Exclusion Criteria
- Pregnancy
- nursing mother
- current tobacco use or regular use within the previous two years
- use of prescription medication other than birth control
- asthma or any other type of lung/respiratory dysfunction
- resting oxygen saturation <95%
- unwillingness to abstain from exercise for 48 hours prior to laboratory testing
- use of anticoagulant therapy or have a known or suspected bleeding disorder
- identification of contraindication during screening (i.e. positive stress test)
- any history of mountain sickness (altitude sickness)
- any history of allergic reaction, hypersensitivity or idiosyncratic reaction to any of the products administered during the study, including allergy to any sulfa or sulfonamide derivatives
- history of clinically significant illness within 4 weeks prior to Day 1
- Subjects who have made any significant donation (including plasma) or have had a significant loss of blood within 30 days prior to visit 1
- receipt of a transfusion or any blood products within 30 days prior to visit 1.
Data sourced from ClinicalTrials.gov (NCT01702025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.