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| Name | Class |
|---|---|
| Defense Advanced Research Projects Agency | FED |
| University of Colorado, Denver | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Administer a single dose of placebo (yellow corn meal in a capsule, gelatin ) in Normoxic Conditions. Following a minimum of 7 days a single dose placebo will be administered (yellow corn meal in a gelatin capsule) in Hypoxic conditions. |
|
| Aminophylline | Active Comparator | Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Normoxic Conditions. Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Hypoxic conditions. |
|
| Methazolamide | Active Comparator | Administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions. Following a minimum of 7 days administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions. |
|
| Aminophylline+Methazolamide | Active Comparator | Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.(Aminophylline+Methazolamide) Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Yellow corn meal in gel capsules |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen). | After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions. | The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Bell, PhD | Colorado State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado State University, Dept. of Health and Exercise Science | Fort Collins | Colorado | 80523-1582 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26680684 | Derived | Scalzo RL, Binns SE, Klochak AL, Giordano GR, Paris HL, Sevits KJ, Beals JW, Biela LM, Larson DG, Luckasen GJ, Irwin D, Schroeder T, Hamilton KL, Bell C. Methazolamide Plus Aminophylline Abrogates Hypoxia-Mediated Endurance Exercise Impairment. High Alt Med Biol. 2015 Dec;16(4):331-42. doi: 10.1089/ham.2015.0066. |
| Label | URL |
|---|---|
| Department of Health and Exercise Science, Colorado State University | View source |
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19 individual participants enrolled in the study. Participants were provided with the opportunity to re-enroll and enter additional arm(s).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia |
| FG001 | Aminophylline | Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia |
| FG002 | Methazolamide | Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia |
| FG003 | Aminophylline + Methazolamide | Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects could choose to participate in multiple arms of the trial. Trial arms were separated by a 7 day wash out period following the hypoxia visit of the previous arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia |
| BG001 | Aminophylline | Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen). | After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions. | Posted | Mean | Standard Error | minutes | The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo Hypoxia . |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Face Tingling | General disorders | Non-systematic Assessment | Tingling sensation in the face |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Bell, Ph.D. | Department of Health and Exercise Science | (970) 491-7522 | christopher.bell@colostate.edu |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000628 | Aminophylline |
| D013806 | Theophylline |
| D008704 | Methazolamide |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 |
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| Aminophylline | Drug | National Drug Code (NDC) 0143-1020-01 |
|
|
| Methazolamide | Drug | NDC 0781-1072-01 |
|
|
| Aminophylline+Methazolamide | Drug | NDC 0143-1020-01 and NDC 0781-1072-01 |
|
|
| Initial Safety Trial For Treatments Under Investigation In Current Study | View source |
| Adverse Event |
|
| BG002 | Methazolamide | Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia |
| BG003 | Aminophylline + Methazolamide | Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Body Fat % | Mean | Standard Deviation | Percentage of body fat |
|
| Fat Mass | Mean | Standard Deviation | kilograms |
|
| Fat Free Mass | Mean | Standard Deviation | kilograms |
|
| maximal oxygen uptake (VO2max) | Mean | Standard Deviation | milliliter/kilogram/minute |
|
| OG001 | Hypoxia Placebo | Placebo: single dose hypoxia |
| OG002 | Normoxia Aminophylline | Aminophylline:single dose Normoxia |
| OG003 | Hypoxia Aminophylline | Aminophylline:single dose hypoxia |
| OG004 | Normoxia Methazolamide | Methazolamide single dose Normoxia |
| OG005 | Hypoxia Methazolamide | Methazolamide: single dose hypoxia |
| OG006 | Normoxia Methazolamide/Aminophylline | Methazolamide combined with Aminophylline: single dose normoxia |
| OG007 | Hypoxia Methazolamide/Aminophylline | Methazolamide combined with Aminophylline: single dose hypoxia |
|
|
| 0 |
| 11 |
| 2 |
| 11 |
| EG001 | Aminophylline | Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia | 0 | 10 | 1 | 10 |
| EG002 | Methazolamide | Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide Hypoxia | 0 | 10 | 2 | 10 |
| EG003 | Aminophylline + Methazolamide | Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia | 0 | 10 | 4 | 10 |
|
| Double vision | General disorders | Non-systematic Assessment |
|
| Lightheadedness | General disorders | Non-systematic Assessment |
|
| Vasovagal | General disorders | Systematic Assessment | Vasovagal response following needle stick |
|
| Hypoglycemic event | General disorders | Systematic Assessment |
|
| cardiac rhythm | General disorders | Systematic Assessment | Changes in premature ventricular contraction 24 days post consumption of study drug |
|
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| Organic Chemicals |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D000470 | Alkaloids |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |