AsthmaPhase 4NCT05977699
Reversibility of Methacholine Induced Bronchoconstriction
A Phase 4 study testing salbutamol aqueous solution and salbutamol pressurized metered dose inhaler in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The study will compare salbutamol reversibility of methacholine induced bronchoconstriction between a pressurized metered dose inhaler with a spacer versus nebulizer administration using a vibrating mesh nebulizer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- salbutamol aqueous solution and salbutamol pressurized metered dose inhaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jan 2024to 25 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age (years) at least 18, male or female
- no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity)
- baseline FEV1 ≥ 65% predicted (per Quanjer GLI 2012)
- methacholine PD20 ≤ 800mcg
Who cannot join
- respiratory infection within 4 weeks of Visit 1
- exposure to triggers of respiratory symptoms within 4 weeks of Visit 1
- currently pregnant or breastfeeding
- current smoker (cigarettes, vaping)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: Salbutamol Reversal of Methacholine Induced Bronchoconstriction: Vibrating Mesh Nebulizer Versus Pressurized Metered Dose Inhaler
The study will compare salbutamol reversibility of methacholine induced bronchoconstriction between a pressurized metered dose inhaler with a spacer versus nebulizer administration using a vibrating mesh nebulizer.
- Conditions
- Asthma
- Being tested
- salbutamol aqueous solution, salbutamol pressurized metered dose inhaler, placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salbutamol aqueous solutionDrug
administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a vibrating mesh nebulizer
salbutamol pressurized metered dose inhalerDrug
administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a pressurized metered dose inhaler plus spacer
placeboOther
matching placebo delivered via pressurized metered dose inhaler plus spacer or normal saline via vibrating mesh nebulizer
| Study group | Role | What they receive |
|---|---|---|
| salbutamol delivered via pressurized metered dose inhaler | Active comparator | 200mcg of salbutamol will be delivered using a pressurized metered dose inhaler plus spacer Receives: Drug: salbutamol pressurized metered dose inhaler |
| placebo | Placebo comparator | normal saline will be administered with a vibrating mesh nebulizer and 200mcg of placebo will be administered using a pressurized metered dose inhaler plus spacer Receives: Other: placebo |
| salbutamol delivered with vibrating mesh nebulizer | Experimental | 200microliters of salbutamol will be administered using a vibrating mesh nebulizer Receives: Drug: salbutamol aqueous solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function recovery
Maximal recovery in FEV1 and FVC (absolute volume and percent)
Measured: up to 60 minutes post salbutamol administration
Secondary outcomes (2)
Time to lung function recovery
Area under the curve from start of salbutamol administration to time at which maximal recovery occurs
Measured: 0-60 minutes
Heart rate
change in pulse after salbutamol administration
Measured: 0-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start12 Jan 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Cockcroft, University of Saskatchewan
- Investigators
- Don Cockcroft, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977699
- Sponsor's protocol ID
- BIO 3632
- Status last verified
- Dec 2024
- First submitted
- 19 Jun 2023
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salbutamol Reversal of Methacholine Induced Bronchoconstriction: Vibrating Mesh Nebulizer Versus Pressurized Metered Dose Inhaler
- ClinicalTrials.gov ID
- NCT05977699
- Acronym / sponsor ID
- BIO 3632
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 4 Aug 2023 (actual)
- 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 study will compare salbutamol reversibility of methacholine induced bronchoconstriction between a pressurized metered dose inhaler with a spacer versus nebulizer administration using a vibrating mesh nebulizer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| salbutamol delivered via pressurized metered dose inhaler | Active comparator | Drug: salbutamol pressurized metered dose inhaler200mcg of salbutamol will be delivered using a pressurized metered dose inhaler plus spacer |
| placebo | Placebo comparator | Other: placebonormal saline will be administered with a vibrating mesh nebulizer and 200mcg of placebo will be administered using a pressurized metered dose inhaler plus spacer |
| salbutamol delivered with vibrating mesh nebulizer | Experimental | Drug: salbutamol aqueous solution200microliters of salbutamol will be administered using a vibrating mesh nebulizer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age (years) at least 18, male or female
- no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity)
- baseline FEV1 ≥ 65% predicted (per Quanjer GLI 2012)
- methacholine PD20 ≤ 800mcg
Key exclusion criteria (4 listed)
- respiratory infection within 4 weeks of Visit 1
- exposure to triggers of respiratory symptoms within 4 weeks of Visit 1
- currently pregnant or breastfeeding
- current smoker (cigarettes, vaping)
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 |
|---|---|---|
| salbutamol aqueous solutionadministration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a vibrating mesh nebulizer | Drug | salbutamol delivered with vibrating mesh nebulizer |
| salbutamol pressurized metered dose inhaleradministration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a pressurized metered dose inhaler plus spacer | Drug | salbutamol delivered via pressurized metered dose inhaler |
| placebomatching placebo delivered via pressurized metered dose inhaler plus spacer or normal saline via vibrating mesh nebulizer | Other | placebo |
Primary outcome
Lung function recovery
Time frame: up to 60 minutes post salbutamol administration
Maximal recovery in FEV1 and FVC (absolute volume and percent)
2 secondary outcomes
Time to lung function recovery
Time frame: 0-60 minutes
Heart rate
Time frame: 0-60 minutes
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 4 May 2026.
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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.
Don Cockcroft, MD principal investigator
University of Saskatchewan
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 salbutamol aqueous solution and salbutamol pressurized metered dose inhaler in people with Asthma, run by University of Saskatchewan 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 4 inclusion and 4 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 4 May 2026. 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?
Lung function recovery (time frame: up to 60 minutes post salbutamol administration). 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 4 May 2026.