HypoxiaPhase 4NCT02758470
Muscle Fatigue and Carbonic Anhydrase Inhibitors
A Phase 4 study testing Acetazolamide and Methazolamide in people with Hypoxia, run by University of British Columbia at 1 site in Canada.
Trial summary
The objective of this research is to assess the effects of acetazolamide and methazolamide on respiratory and limb muscle fatigue development. A fatiguing protocol will be conducted for the respiratory and plantar flexor muscles and the difference in pressure/torque produced by supramaximal nerve stimulation used to… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Acetazolamide and Methazolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to 30 Jun 2017
- Phase
- Phase 4
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-40 years.
- Regularly physically active
- Male
Who cannot join
- current or ex-smokers
- pulmonary function <80% of predicted
- esophageal tumour or ulcer
- have had recent (<6 months) musculoskeletal injury or any surgery to the lower leg
- have contraindications to carbonic anhydrase inhibitors (eg. severe or absolute glaucoma, adrenocortical insufficiency, hepatic insufficiency, renal insufficiency, sulfa allergy or an electrolyte imbalance such as hyperchloremic acidosis)
- are obese (BMI >30 Kg/m2)
- taking diuretics, blood thinners, or anti-platelet drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Carbonic Anhydrase Inhibitors on the Pulmonary System Response to Muscle Fatigue.
The objective of this research is to assess the effects of acetazolamide and methazolamide on respiratory and limb muscle fatigue development. A fatiguing protocol will be conducted for the respiratory and plantar flexor muscles and the difference in pressure/torque produced by supramaximal nerve stimulation used to assess muscle fatigue between conditions.
- Conditions
- Hypoxia
- Being tested
- Acetazolamide, Methazolamide, Placebo
- Keywords
- Muscle Fatigue, Acetazolamide, Methazolamide
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
250 mg, taken orally three times per day
MethazolamideDrug
100mg, taken orally two times per day. A placebo pill will be taken between each dose of methazolamide to match the timing of doses and the number of pills between study arms.
PlaceboOther
A placebo will be taken three times per day
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Experimental | Participants will be dosed 250mg acetazolamide (p.o.) three times per day for two days prior to and a single dose on the morning of the experimental day. Receives: Drug: Acetazolamide |
| Methazolamide | Experimental | Participants will be dosed 100mg Methazolamide (p.o.) two times per day separated by a placebo dose for two days prior to and a single dose on the morning of the experimental day. The placebo dose is used to match the timing and number of pills taken between all arms of the study. Receives: Drug: Methazolamide |
| Placebo | Placebo comparator | Participants will take three placebo pills per day for two days prior to and a single dose on the morning of the experimental day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trans-diaphragmatic pressure generation to supramaximal phrenic nerve stimulation following inspiratory threshold loading.
Measured: Baseline, 1, 5, 10, 20, and 30 minutes following the loading protocol for each arm of the study
Change in plantar flexor muscle group torque generation to supramaximal tibial nerve stimulation following an isometric loading protocol
Measured: Baseline, 1, 5, 10, 20, and 30 minutes following the loading protocol for each arm of the study
Secondary outcomes (3)
Maximal inspiratory pressure maneuvers
Measured: Baseline and immediately following loading protocol
Maximal Voluntary Contraction of the Plantar Flexor Muscle Group
Measured: Baseline and immediately following the loading protocol
Contraction time and half-relaxation time
Measured: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startNov 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 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 HypoxiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glen Foster, University of British Columbia
- Investigators
- Glen E Foster, Ph.D., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758470
- Sponsor's protocol ID
- H16-00896
- Status last verified
- Sep 2018
- First submitted
- 20 Apr 2016
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Dominelli PB, McNeil CJ, Vermeulen TD, Stuckless TJR, Brown CV, Dominelli GS, Swenson ER, Teppema LJ, Foster GE. Effect of acetazolamide and methazolamide on diaphragm and dorsiflexor fatigue: a randomized controlled trial. J Appl Physiol (1985). 2018 Sep 1;125(3):770-779. doi: 10.1152/japplphysiol.00256.2018. Epub 2018 May 24.
PubMed 29792554
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Carbonic Anhydrase Inhibitors on the Pulmonary System Response to Muscle Fatigue.
- ClinicalTrials.gov ID
- NCT02758470
- Acronym / sponsor ID
- H16-00896
- Conditions
- Hypoxia
- Keywords
- Muscle Fatigue, Acetazolamide, Methazolamide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 2 May 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.
The objective of this research is to assess the effects of acetazolamide and methazolamide on respiratory and limb muscle fatigue development. A fatiguing protocol will be conducted for the respiratory and plantar flexor muscles and the difference in pressure/torque produced by supramaximal nerve stimulation used to assess muscle fatigue between conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Experimental | Drug: AcetazolamideParticipants will be dosed 250mg acetazolamide (p.o.) three times per day for two days prior to and a single dose on the morning of the experimental day. |
| Methazolamide | Experimental | Drug: MethazolamideParticipants will be dosed 100mg Methazolamide (p.o.) two times per day separated by a placebo dose for two days prior to and a single dose on the morning of the experimental day. The placebo dose is used to match the timing and number of pills taken between all arms of the study. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will take three placebo pills per day for two days prior to and a single dose on the morning of the experimental day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-40 years.
- Regularly physically active
- Male
Key exclusion criteria (7 listed)
- current or ex-smokers
- pulmonary function <80% of predicted
- esophageal tumour or ulcer
- have had recent (<6 months) musculoskeletal injury or any surgery to the lower leg
- have contraindications to carbonic anhydrase inhibitors (eg. severe or absolute glaucoma, adrenocortical insufficiency, hepatic insufficiency, renal insufficiency, sulfa allergy or an electrolyte imbalance such as hyperchloremic acidosis)
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 |
|---|---|---|
| Acetazolamide250 mg, taken orally three times per day | Drug | Acetazolamide |
| Methazolamide100mg, taken orally two times per day. A placebo pill will be taken between each dose of methazolamide to match the timing of doses and the number of pills between study arms. | Drug | Methazolamide |
| PlaceboA placebo will be taken three times per day | Other | Placebo |
Primary outcome
Change in trans-diaphragmatic pressure generation to supramaximal phrenic nerve stimulation following inspiratory threshold loading.
Time frame: Baseline, 1, 5, 10, 20, and 30 minutes following the loading protocol for each arm of the study
Change in plantar flexor muscle group torque generation to supramaximal tibial nerve stimulation following an isometric loading protocol
Time frame: Baseline, 1, 5, 10, 20, and 30 minutes following the loading protocol for each arm of the study
3 secondary outcomes
Maximal inspiratory pressure maneuvers
Time frame: Baseline and immediately following loading protocol
Maximal Voluntary Contraction of the Plantar Flexor Muscle Group
Time frame: Baseline and immediately following the loading protocol
Contraction time and half-relaxation time
Time frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
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 25 Sep 2018.
- Results publication: PubMed 29792554Dominelli PB, McNeil CJ, Vermeulen TD, Stuckless TJR, Brown CV, Dominelli GS, Swenson ER, Teppema LJ, Foster GE. Effect of acetazolamide and methazolamide on diaphragm and dorsiflexor fatigue: a randomized controlled trial. J Appl Physiol (1985). 2018 Sep 1;125(3):770-779. doi: 10.1152/japplphysiol.00256.2018. Epub 2018 May 24.
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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.
Glen E Foster, Ph.D. principal investigator
University of British Columbia
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 and Methazolamide in people with Hypoxia, run by University of British Columbia at 1 site in Canada.
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 3 inclusion and 7 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 25 Sep 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 Canada. 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?
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?
Change in trans-diaphragmatic pressure generation to supramaximal phrenic nerve stimulation following inspiratory threshold loading. (time frame: Baseline, 1, 5, 10, 20, and 30 minutes following the loading protocol for each arm of the study). The study lists 2 primary outcomes in all. 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 NCT02758470, 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 25 Sep 2018.