AsthmaNCT02630511
Asthma Exacerbations and Vascular Function
A study testing Mannitol, Methacholine and Rest in people with Asthma, run by University of Alberta at 1 site in Canada.
Trial summary
Although asthma is a disease of the airways, research is now showing that asthmatics are more likely to develop cardiovascular disease (CVD) compared to non-asthmatics. Vascular dysfunction is seen in people at high risk of CVD and has been linked to inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Mannitol, Methacholine and Rest
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to Dec 2020
- Phase
- Interventional
- 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
- Asthmatics, defined according to ATS and GINA guidelines,
- BMI <35kg/m2
- No known cardiovascular disease
- ACQ score equal to or less than 1.5 (controlled or partly controlled asthma)
- People without asthma (controls) will be recruited from the general population according to the same criteria, but with no history of asthma.
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Physiology Research Laboratory
Edmonton, Alberta, T6G 2J1
About this study
Although asthma is a disease of the airways, research is now showing that asthmatics are more likely to develop cardiovascular disease (CVD) compared to non-asthmatics. Vascular dysfunction is seen in people at high risk of CVD and has been linked to inflammation. During an asthma attack, levels of inflammation in the whole body increase, which could potentially explain why asthmatics are at increased risk of CVD. By exercising, people can change the amount of inflammation in their bodies, improve vascular function, and thereby reduce the risk of CVD. In the proposed study the investigators will assess if asthma attacks lead to increased risk of CVD by evaluating inflammatory levels and vascular function before and after asthma attacks. The investigators will also evaluate if exercise reduces the cardiovascular risk following asthma attacks. The results from this study will help in understanding why asthmatics are at increased risk of CVD.
Read the detailed description
BACKGROUND \& SCOPE: While asthma is generally considered to be a disease of the airways, there are important systemic consequences which have predisposed people with asthma to become more likely to die from cardiovascular (CV) disease compared to non-asthmatics. Additional CV risks have been reported in people with severe asthma, and there is a relationship between reductions in lung function and cardiac death. To date, little is known in regards to the interaction between asthma exacerbations and CV risk.
Brachial flow-mediated dilation (FMD) is used as a non-invasive tool to evaluate endothelial function. Brachial FMD is impaired in people with coronary dysfunction, and has been shown to predict future CV events better than traditional CV risk factors. People with asthma have previously been shown to have impaired endothelial function compared to non-asthmatics, but the underlying mechanism(s) are unclear.
Chronic systemic inflammation is an established risk factor and predictor of future CV events, and levels of systemic inflammation has been shown to be increased in asthma and to be are related to disease severity. While systemic inflammation can directly impair vascular function, it is unknown how an asthma attack may affect vascular function and CV risk. Thus, to gain better understanding of the increased CV risks associated with asthma exacerbations, the first aim of this study is to evaluate how acutely increased pulmonary inflammation affects vascular function in people with asthma.
Physical inactivity has previously been associated with increased systemic inflammation, while higher levels of physical activity can reduce inflammation and vascular dysfunction. Acute exercise has been shown to modulate the systemic responses to inflammatory insults, and being more physically active is associated with better asthma symptoms but whether acute exercise influences the systemic responses to asthma exacerbations is unknown. The second aim is to assess the influence of acute exercise on the systemic and vascular responses to acute pulmonary inflammation in asthma.
OBJECTIVE 1: To examine the acute impact of pulmonary inflammation and bronchoconstriction on systemic inflammation and vascular function in asthma.
METHODS \& PROCEDURES, objective 1: Outline: Asthmatics will undergo a screening and three trials for which they will report to the laboratory in the morning of two consecutive days (Day 1 and Day 2) per trial. The screening day is to establish presence/absence of asthma and and will consist of pulmonary function testing before and after inhalation of a bronchodilator (Salbutamol), and an exercise challenge and cardiopulmonary fitness test. On Day 1, baseline pulmonary function and vascular function will be evaluated, and venous blood samples and exhaled breath condensate will also be obtained for evaluation of baseline systemic and pulmonary inflammation, respectively. The participants will then undergo either a mannitol challenge (Trial 1), a methacholine challenge (Trial 2), or a placebo (saline) challenge (Trial 3). At 1 hour post-challenge, another set of vascular function measurements, and systemic and pulmonary inflammation measurements will be done. The participants will be asked to come back 24 hours after each trial (Day 2) for a follow-up evaluation of vascular function and systemic inflammation. The order of the trials will be randomized and they will be separated by 1 week to allow for washout between tests.
Pulmonary function: A standard pulmonary function test will be performed by all participants as per established clinical guidelines.
Pulmonary inflammation: Exhaled breath condensate will be collected using RTube™ and analyzed for levels of CRP and markers of oxidative stress.
Systemic inflammation: The analysis of serum CRP, IL-6, TNFα, and nitrates and nitrites levels will be outsourced to Eve Technologies, Calgary.
Vascular function: Flow-mediated dilation (FMD) of the brachial artery following 5 minutes of forearm occlusion will be measured ultrasound imaging using our ultrasound machine. FMD will be determined using Doppler ultrasound immediately after the release of the occlusion. The secondary outcome is arterial stiffness, which will be determined using carotid - femoral/brachial pulse wave velocity, and PWV will be calculated from measurements of pulse transit time and the distance traveled by the pulse between recording sites.
Mannitol, methacholine and placebo challenge: Mannitol challenges have been shown to induce pulmonary inflammation in addition to bronchoconstriction in asthmatics and will be performed until either a cumulative dose of 635 mg has been obtained or until there is a reduction in the forced expiratory volume in the first second (FEV1) of ≥10% of baseline values. If bronchoconstriction occurs, the FEV1 will be monitored every 10 minutes until spontaneous recovery to within 5% of baseline FEV1, or reversed using 4 puffs (100 mg/puff) Salbutamol. Peripheral oxygen saturation will be monitored throughout the test. A methacholine challenge causes bronchoconstriction without an increase in pulmonary inflammation in asthmatics and will be used to separate between the effects of bronchoconstriction and pulmonary inflammation on vascular function. Except for the inhalation of methacholine, which will be performed according to established guidelines (in incremental concentrations until either 16 mg/ml methacholine has been inhaled, or there is a 20% reduction in FEV1), the same protocol will be used for the methacholine challenge and the placebo challenges. The participants will be blinded to the order of the tests.
OBJECTIVE 2: To evaluate the influence of acute exercise on systemic inflammatory and vascular responses to acute pulmonary inflammation.
METHODS \& PROCEDURES, objective 2: Outline: The design of Objective 2 will be similar to the Mannitol challenge day in Objective 1 except the participants will in random order either a) exercise and inhale mannitol, b) exercise and placebo (saline), c) rest and inhale mannitol, or d) rest and placebo (saline). In addition to the inflammatory markers measured in Objective 1, the anti-inflammatory cytokine IL-10 will be measured in serum at each time point (baseline, 1 hour post-challenge, and 1 day post-challenge).
The exercise work load on the challenge day will correspond to 25 watts below achieved workload at anaerobic threshold during the screening day cardiopulmonary fitness test and will be held for 30 minutes. For the inactive day, the participants will be asked to withhold any exercise and/or moderate to heavy physical activity for 48 hours prior to the test. On the resting trial day, the participant will report to the lab at the same time of day as for exercise and instead rest quietly during for the same duration as the exercise period.
- Conditions
- Asthma
- Being tested
- Mannitol, Methacholine, Placebo, Rest, Exercise
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
Also called Mannitol Challenge Test
Mannitol consists of inhaling 0 (empty capsule acting as a placebo), 5, 10, 20, 40, 80, 160, 160, and 160 mg mannitol, resulting in a maximum cumulative dose of 635 mg
MethacholineDrug
Also called Methacholine Challenge Test
Methacholine consists of inhaling 0.0625 mg/mL, 0.25 mg/mL, 1 mg/mL, 4 mg/mL, and 16 mg/mL
PlaceboDrug
Also called Placebo Challenge Test
Placebo consists of inhaling humidified air
RestOther
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Asthma Group | Experimental | Asthma group to receive mannitol, methacholine or placebo challenge tests Receives: Drug: Mannitol; Drug: Methacholine; Drug: Placebo; Other: Rest; Other: Exercise |
| Control Group | Experimental | Control group to receive mannitol, methacholine or placebo challenge tests Receives: Drug: Mannitol; Drug: Methacholine; Drug: Placebo; Other: Rest; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline flow-mediated dilation (FMD) to 15 minutes and 1 hour following bronchial challenge
Flow-mediated dilation (FMD) of the brachial artery following 5 minutes of forearm occlusion will be measured using ultrasound (8L-RS 4.0-13.0 MHz probe, Vivid q, GE Healthcare, Mississauga, ON) and FMD data will be analyzed using FDA approved software available from Medical Imaging Applications (Coralville, IA, USA). FMD will be calculated as: (peak hyperemic diameter-baseline diameter)/baseline diameter x 100. FMD will be normalized for baseline diameter. Peak hyperemic brachial arterial velocity (and subsequently shear stress) will be determined using Doppler ultrasound, and used for normalization of FMD.
Measured: At baseline, 15 min, 1 hour, and 24 hours following each intervention
Secondary outcomes (4)
Change from baseline arterial stiffness (cPWV) to 15 minutes and 1 hour following bronchial challenge
Arterial stiffness will be determined using carotid - femoral pulse wave velocity (cPWV), and PWV will be calculated from measurements of pulse transit time and the distance traveled by the pulse between recording sites.
Measured: At baseline, 15 min, 1 hour, and 24 hours following each intervention
Change from baseline arterial stiffness (pPWV) to 15 minutes and 1 hour following bronchial challenge
Arterial stiffness will be determined using carotid - radial pulse wave velocity (pPWV), and PWV will be calculated from measurements of pulse transit time and the distance traveled by the pulse between recording sites.
Measured: At baseline, 15 min, 1 hour, and 24 hours following each intervention
Change from baseline systemic inflammation to 15 minutes and 1 hour following bronchial challenge
Serum analysis of inflammatory markers (i.e. of IL-6, IL-8, TNFα, and CRP).
Measured: At baseline, 15 min, 1 hour, and 24 hours following each intervention
Change from baseline pulmonary inflammation to 15 minutes and 1 hour following bronchial challenge
Exhaled breath condensate (EBC) will be collected for analysis of CRP and 8-isoprostane.
Measured: At baseline, 15 min, 1 hour, and 24 hours following each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2020
- Study completionDec 2020
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 AsthmaStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized double-blind cross over design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael K Stickland, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630511
- Sponsor's protocol ID
- Pro00047054
- Status last verified
- Jun 2021
- First submitted
- 4 Dec 2015
- Last updated
- 1 Jul 2021
- Results posted
- No
Publications
Moore LE, Brotto AR, Fuhr DP, Rosychuk RJ, Wong E, Bhutani M, Stickland MK. Impact of airway challenges on cardiovascular risk in asthma - a randomized controlled trial. PLoS One. 2023 Jul 17;18(7):e0288623. doi: 10.1371/journal.pone.0288623. eCollection 2023.
PubMed 37459335
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Exacerbations and Vascular Function
- ClinicalTrials.gov ID
- NCT02630511
- Acronym / sponsor ID
- Pro00047054
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 15 Dec 2015 (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.
Although asthma is a disease of the airways, research is now showing that asthmatics are more likely to develop cardiovascular disease (CVD) compared to non-asthmatics. Vascular dysfunction is seen in people at high risk of CVD and has been linked to inflammation. During an asthma attack, levels of inflammation in the whole body increase, which could potentially explain why asthmatics are at increased risk of CVD. By exercising, people can change the amount of inflammation in their bodies, improve vascular function, and thereby reduce the risk of CVD. In the proposed study the investigators will assess if asthma attacks lead to increased risk of CVD by evaluating inflammatory levels and vascular function before and after asthma attacks. The investigators will also evaluate if exercise reduces the cardiovascular risk following asthma attacks. The results from this study will help in understanding why asthmatics are at increased risk of CVD.
Detailed description
BACKGROUND \& SCOPE: While asthma is generally considered to be a disease of the airways, there are important systemic consequences which have predisposed people with asthma to become more likely to die from cardiovascular (CV) disease compared to non-asthmatics. Additional CV risks have been reported in people with severe asthma, and there is a relationship between reductions in lung function and cardiac death. To date, little is known in regards to the interaction between asthma exacerbations and CV risk.
Brachial flow-mediated dilation (FMD) is used as a non-invasive tool to evaluate endothelial function. Brachial FMD is impaired in people with coronary dysfunction, and has been shown to predict future CV events better than traditional CV risk factors. People with asthma have previously been shown to have impaired endothelial function compared to non-asthmatics, but the underlying mechanism(s) are unclear.
Chronic systemic inflammation is an established risk factor and predictor of future CV events, and levels of systemic inflammation has been shown to be increased in asthma and to be are related to disease severity. While systemic inflammation can directly impair vascular function, it is unknown how an asthma attack may affect vascular function and CV risk. Thus, to gain better understanding of the increased CV risks associated with asthma exacerbations, the first aim of this study is to evaluate how acutely increased pulmonary inflammation affects vascular function in people with asthma.
Physical inactivity has previously been associated with increased systemic inflammation, while higher levels of physical activity can reduce inflammation and vascular dysfunction. Acute exercise has been shown to modulate the systemic responses to inflammatory insults, and being more physically active is associated with better asthma symptoms but whether acute exercise influences the systemic responses to asthma exacerbations is unknown. The second aim is to assess the influence of acute exercise on the systemic and vascular responses to acute pulmonary inflammation in asthma.
OBJECTIVE 1: To examine the acute impact of pulmonary inflammation and bronchoconstriction on systemic inflammation and vascular function in asthma.
METHODS \& PROCEDURES, objective 1: Outline: Asthmatics will undergo a screening and three trials for which they will report to the laboratory in the morning of two consecutive days (Day 1 and Day 2) per trial. The screening day is to establish presence/absence of asthma and and will consist of pulmonary function testing before and after inhalation of a bronchodilator (Salbutamol), and an exercise challenge and cardiopulmonary fitness test. On Day 1, baseline pulmonary function and vascular function will be evaluated, and venous blood samples and exhaled breath condensate will also be obtained for evaluation of baseline systemic and pulmonary inflammation, respectively. The participants will then undergo either a mannitol challenge (Trial 1), a methacholine challenge (Trial 2), or a placebo (saline) challenge (Trial 3). At 1 hour post-challenge, another set of vascular function measurements, and systemic and pulmonary inflammation measurements will be done. The participants will be asked to come back 24 hours after each trial (Day 2) for a follow-up evaluation of vascular function and systemic inflammation. The order of the trials will be randomized and they will be separated by 1 week to allow for washout between tests.
Pulmonary function: A standard pulmonary function test will be performed by all participants as per established clinical guidelines.
Pulmonary inflammation: Exhaled breath condensate will be collected using RTube™ and analyzed for levels of CRP and markers of oxidative stress.
Systemic inflammation: The analysis of serum CRP, IL-6, TNFα, and nitrates and nitrites levels will be outsourced to Eve Technologies, Calgary.
Vascular function: Flow-mediated dilation (FMD) of the brachial artery following 5 minutes of forearm occlusion will be measured ultrasound imaging using our ultrasound machine. FMD will be determined using Doppler ultrasound immediately after the release of the occlusion. The secondary outcome is arterial stiffness, which will be determined using carotid - femoral/brachial pulse wave velocity, and PWV will be calculated from measurements of pulse transit time and the distance traveled by the pulse between recording sites.
Mannitol, methacholine and placebo challenge: Mannitol challenges have been shown to induce pulmonary inflammation in addition to bronchoconstriction in asthmatics and will be performed until either a cumulative dose of 635 mg has been obtained or until there is a reduction in the forced expiratory volume in the first second (FEV1) of ≥10% of baseline values. If bronchoconstriction occurs, the FEV1 will be monitored every 10 minutes until spontaneous recovery to within 5% of baseline FEV1, or reversed using 4 puffs (100 mg/puff) Salbutamol. Peripheral oxygen saturation will be monitored throughout the test. A methacholine challenge causes bronchoconstriction without an increase in pulmonary inflammation in asthmatics and will be used to separate between the effects of bronchoconstriction and pulmonary inflammation on vascular function. Except for the inhalation of methacholine, which will be performed according to established guidelines (in incremental concentrations until either 16 mg/ml methacholine has been inhaled, or there is a 20% reduction in FEV1), the same protocol will be used for the methacholine challenge and the placebo challenges. The participants will be blinded to the order of the tests.
OBJECTIVE 2: To evaluate the influence of acute exercise on systemic inflammatory and vascular responses to acute pulmonary inflammation.
METHODS \& PROCEDURES, objective 2: Outline: The design of Objective 2 will be similar to the Mannitol challenge day in Objective 1 except the participants will in random order either a) exercise and inhale mannitol, b) exercise and placebo (saline), c) rest and inhale mannitol, or d) rest and placebo (saline). In addition to the inflammatory markers measured in Objective 1, the anti-inflammatory cytokine IL-10 will be measured in serum at each time point (baseline, 1 hour post-challenge, and 1 day post-challenge).
The exercise work load on the challenge day will correspond to 25 watts below achieved workload at anaerobic threshold during the screening day cardiopulmonary fitness test and will be held for 30 minutes. For the inactive day, the participants will be asked to withhold any exercise and/or moderate to heavy physical activity for 48 hours prior to the test. On the resting trial day, the participant will report to the lab at the same time of day as for exercise and instead rest quietly during for the same duration as the exercise period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blind cross over design
| Arm | Type | Receives |
|---|---|---|
| Asthma Group | Experimental | Drug: Mannitol, Drug: Methacholine, Drug: Placebo, Other: Rest, Other: ExerciseAsthma group to receive mannitol, methacholine or placebo challenge tests |
| Control Group | Experimental | Drug: Mannitol, Drug: Methacholine, Drug: Placebo, Other: Rest, Other: ExerciseControl group to receive mannitol, methacholine or placebo challenge tests |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Asthmatics, defined according to ATS and GINA guidelines,
- BMI <35kg/m2
- No known cardiovascular disease
- ACQ score equal to or less than 1.5 (controlled or partly controlled asthma)
- People without asthma (controls) will be recruited from the general population according to the same criteria, but with no history of asthma.
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| MannitolAlso: Mannitol Challenge TestMannitol consists of inhaling 0 (empty capsule acting as a placebo), 5, 10, 20, 40, 80, 160, 160, and 160 mg mannitol, resulting in a maximum cumulative dose of 635 mg | Drug | Asthma Group, Control Group |
| MethacholineAlso: Methacholine Challenge TestMethacholine consists of inhaling 0.0625 mg/mL, 0.25 mg/mL, 1 mg/mL, 4 mg/mL, and 16 mg/mL | Drug | Asthma Group, Control Group |
| PlaceboAlso: Placebo Challenge TestPlacebo consists of inhaling humidified air | Drug | Asthma Group, Control Group |
| Rest | Other | Asthma Group, Control Group |
| Exercise | Other | Asthma Group, Control Group |
Primary outcome
Change from baseline flow-mediated dilation (FMD) to 15 minutes and 1 hour following bronchial challenge
Time frame: At baseline, 15 min, 1 hour, and 24 hours following each intervention
Flow-mediated dilation (FMD) of the brachial artery following 5 minutes of forearm occlusion will be measured using ultrasound (8L-RS 4.0-13.0 MHz probe, Vivid q, GE Healthcare, Mississauga, ON) and FMD data will be analyzed using FDA approved software available from Medical Imaging Applications (Coralville, IA, USA). FMD will be calculated as: (peak hyperemic diameter-baseline diameter)/baseline diameter x 100. FMD will be normalized for baseline diameter. Peak hyperemic brachial arterial velocity (and subsequently shear stress) will be determined using Doppler ultrasound, and used for normalization of FMD.
4 secondary outcomes
Change from baseline arterial stiffness (cPWV) to 15 minutes and 1 hour following bronchial challenge
Time frame: At baseline, 15 min, 1 hour, and 24 hours following each intervention
Change from baseline arterial stiffness (pPWV) to 15 minutes and 1 hour following bronchial challenge
Time frame: At baseline, 15 min, 1 hour, and 24 hours following each intervention
Change from baseline systemic inflammation to 15 minutes and 1 hour following bronchial challenge
Time frame: At baseline, 15 min, 1 hour, and 24 hours following each intervention
Change from baseline pulmonary inflammation to 15 minutes and 1 hour following bronchial challenge
Time frame: At baseline, 15 min, 1 hour, and 24 hours following each intervention
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 1 Jul 2021.
- Derived from this study: PubMed 37459335Moore LE, Brotto AR, Fuhr DP, Rosychuk RJ, Wong E, Bhutani M, Stickland MK. Impact of airway challenges on cardiovascular risk in asthma - a randomized controlled trial. PLoS One. 2023 Jul 17;18(7):e0288623. doi: 10.1371/journal.pone.0288623. eCollection 2023.
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Asthma
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.
Michael K Stickland, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mannitol, Methacholine and Rest in people with Asthma, run by University of Alberta 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 5 inclusion and 1 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 1 Jul 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 from baseline flow-mediated dilation (FMD) to 15 minutes and 1 hour following bronchial challenge (time frame: At baseline, 15 min, 1 hour, and 24 hours following each intervention). 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 NCT02630511, 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 1 Jul 2021.