AsthmaPhase 3NCT03505489
The Effect of Deep Inhalation on Mannitol Responsiveness
A Phase 3 study testing Deep inhalation technique, Tidal breathing technique and Methacholine in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The study will assess how the inhalation technique used (deep inhalations versus tidal breathing) influences the results of a mannitol challenge test and a methacholine challenge test, if at all. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Deep inhalation technique, Tidal breathing technique and Methacholine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 30 Apr 2019
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent
- men and women between 18 and 75 years of age
- FEV1 at first measurement of greater than or equal to 65% predicted
- methacholine provocative concentration causing a 20% in FEV1 at screening that is less than or equal to 16mg/ml
- generally good health
- stable asthma
Who cannot join
- respiratory infection within 4 weeks of screening visit
- worsening of asthma within 4 weeks of screening visit
- lung disease other than asthma
- significant medical comorbidity
- current smoker or ex-smoker with significant smoking history
- currently pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Canada1 site
Asthma Research Lab - University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
The study will assess how the inhalation technique used (deep inhalations versus tidal breathing) influences the results of a mannitol challenge test and a methacholine challenge test, if at all.
Read the detailed description
This study will look at airway responsiveness to inhaled methacholine and mannitol administered with and without deep inhalation. This study will also investigate the role of airway inflammation on these responses, using sputum differential cell counts and fractional exhaled nitric oxide.
This is a single center, open label, randomized study. Individuals with stable asthma will be eligible for enrollment. The study will consist of two parts, screening and testing.
Part 1: Screening
Participants will undergo consent procedures and assessments of fractional exhaled nitric oxide levels, airway responsiveness to methacholine and sputum induction. If participants show airway responsiveness to methacholine (i.e. methacholine PC20 16mg/mL), they will be scheduled to undergo the testing part of the study.
Part 2: Testing
Participants will be randomized to undergo two methacholine or two mannitol challenges. Further randomization will occur with respect to whether the standard challenge method or the modified challenge method is performed first.
- Conditions
- Asthma
- Being tested
- Deep inhalation technique, Tidal breathing technique, Methacholine, Mannitol
- Keywords
- Mannitol, Methacholine, Deep inhalation, Tidal breathing
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep inhalation techniqueProcedure or surgery
Use of deep inhalations for administration of inhalant
Tidal breathing techniqueProcedure or surgery
Use of tidal breathing for administration of inhalant
MethacholineDrug
Also called Provocholine
Methacholine direct bronchoconstrictor used for bronchoprovocation challenge
MannitolDrug
Also called Aridol
Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge
| Study group | Role | What they receive |
|---|---|---|
| Mannitol challenge | Experimental | Mannitol challenge performed per standard mannitol challenge procedure with deep inhalation technique Receives: Procedure: Deep inhalation technique; Drug: Mannitol |
| Mannitol challenge w/ TBI | Experimental | Mannitol challenge performed per standard mannitol challenge procedure except with tidal breathing technique Receives: Procedure: Tidal breathing technique; Drug: Mannitol |
| Methacholine challenge w/ DI | Experimental | Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure except with deep inhalation technique Receives: Procedure: Deep inhalation technique; Drug: Methacholine |
| Methacholine challenge | Experimental | Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure (tidal breathing technique) Receives: Procedure: Tidal breathing technique; Drug: Methacholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of deep inhalation (versus tidal breathing) on mannitol provocative dose causing a 15% fall in forced expiratory volume in one second (FEV1)
Shift in mannitol provocative dose causing a 15% fall in forced expiratory volume
Measured: 24 hours between mannitol challenges
Secondary outcomes (3)
Effect of airway inflammation on methacholine and mannitol challenge results-fractional exhaled nitric oxide
Collection of fractional exhaled nitric oxide at screening - analysis of resulting measurement indicative of degree of baseline airway inflammation
Measured: up to 2 weeks, from baseline to end of study
Effect of airway inflammation on methacholine and mannitol challenge results-sputum
Collection of sputum at screening - analysis for differential cell counts indicative of degree of baseline airway inflammation
Measured: up to 2 weeks, from baseline to end of study
Effect of deep inhalation (versus tidal breathing) on methacholine provocative
Shift in methacholine provocative dose causing a 20% fall in forced expiratory volume
Measured: 24 hours between methacholine challenges
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 Jun 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 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
- Dr. Don Cockcroft, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505489
- Sponsor's protocol ID
- MAN-2018
- Status last verified
- May 2019
- First submitted
- 29 Mar 2018
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blais CM, Davis BE, Cockcroft DW. The effect of deep inhalation on mannitol responsiveness. Clin Exp Allergy. 2020 Mar;50(3):308-314. doi: 10.1111/cea.13543. Epub 2019 Dec 14.
PubMed 31785175Blais CM, Davis BE, Graham BL, Cockcroft DW. Respiratory Duty Cycles in Individuals With and Without Airway Hyperresponsiveness. Chest. 2020 Feb;157(2):356-362. doi: 10.1016/j.chest.2019.09.005. Epub 2019 Sep 19.
PubMed 31542451
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Inhalation on Mannitol Responsiveness
- ClinicalTrials.gov ID
- NCT03505489
- Acronym / sponsor ID
- MAN-2018
- Conditions
- Asthma
- Keywords
- Mannitol, Methacholine, Deep inhalation, Tidal breathing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 23 Apr 2018 (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 assess how the inhalation technique used (deep inhalations versus tidal breathing) influences the results of a mannitol challenge test and a methacholine challenge test, if at all.
Detailed description
This study will look at airway responsiveness to inhaled methacholine and mannitol administered with and without deep inhalation. This study will also investigate the role of airway inflammation on these responses, using sputum differential cell counts and fractional exhaled nitric oxide.
This is a single center, open label, randomized study. Individuals with stable asthma will be eligible for enrollment. The study will consist of two parts, screening and testing.
Part 1: Screening
Participants will undergo consent procedures and assessments of fractional exhaled nitric oxide levels, airway responsiveness to methacholine and sputum induction. If participants show airway responsiveness to methacholine (i.e. methacholine PC20 16mg/mL), they will be scheduled to undergo the testing part of the study.
Part 2: Testing
Participants will be randomized to undergo two methacholine or two mannitol challenges. Further randomization will occur with respect to whether the standard challenge method or the modified challenge method is performed first.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mannitol challenge | Experimental | Procedure: Deep inhalation technique, Drug: MannitolMannitol challenge performed per standard mannitol challenge procedure with deep inhalation technique |
| Mannitol challenge w/ TBI | Experimental | Procedure: Tidal breathing technique, Drug: MannitolMannitol challenge performed per standard mannitol challenge procedure except with tidal breathing technique |
| Methacholine challenge w/ DI | Experimental | Procedure: Deep inhalation technique, Drug: MethacholineMethacholine challenge performed per standard 2-minute tidal breathing challenge procedure except with deep inhalation technique |
| Methacholine challenge | Experimental | Procedure: Tidal breathing technique, Drug: MethacholineMethacholine challenge performed per standard 2-minute tidal breathing challenge procedure (tidal breathing technique) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- signed informed consent
- men and women between 18 and 75 years of age
- FEV1 at first measurement of greater than or equal to 65% predicted
- methacholine provocative concentration causing a 20% in FEV1 at screening that is less than or equal to 16mg/ml
- generally good health
Key exclusion criteria (6 listed)
- respiratory infection within 4 weeks of screening visit
- worsening of asthma within 4 weeks of screening visit
- lung disease other than asthma
- significant medical comorbidity
- current smoker or ex-smoker with significant smoking history
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 |
|---|---|---|
| Deep inhalation techniqueUse of deep inhalations for administration of inhalant | Procedure or surgery | Mannitol challenge, Methacholine challenge w/ DI |
| Tidal breathing techniqueUse of tidal breathing for administration of inhalant | Procedure or surgery | Mannitol challenge w/ TBI, Methacholine challenge |
| MethacholineAlso: ProvocholineMethacholine direct bronchoconstrictor used for bronchoprovocation challenge | Drug | Methacholine challenge, Methacholine challenge w/ DI |
| MannitolAlso: AridolMannitol indirect bronchoconstrictor used for bronchoprovocation challenge | Drug | Mannitol challenge, Mannitol challenge w/ TBI |
Primary outcome
Effect of deep inhalation (versus tidal breathing) on mannitol provocative dose causing a 15% fall in forced expiratory volume in one second (FEV1)
Time frame: 24 hours between mannitol challenges
Shift in mannitol provocative dose causing a 15% fall in forced expiratory volume
3 secondary outcomes
Effect of airway inflammation on methacholine and mannitol challenge results-fractional exhaled nitric oxide
Time frame: up to 2 weeks, from baseline to end of study
Effect of airway inflammation on methacholine and mannitol challenge results-sputum
Time frame: up to 2 weeks, from baseline to end of study
Effect of deep inhalation (versus tidal breathing) on methacholine provocative
Time frame: 24 hours between methacholine challenges
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 15 May 2019.
- Derived from this study: PubMed 31785175Blais CM, Davis BE, Cockcroft DW. The effect of deep inhalation on mannitol responsiveness. Clin Exp Allergy. 2020 Mar;50(3):308-314. doi: 10.1111/cea.13543. Epub 2019 Dec 14.
- Derived from this study: PubMed 31542451Blais CM, Davis BE, Graham BL, Cockcroft DW. Respiratory Duty Cycles in Individuals With and Without Airway Hyperresponsiveness. Chest. 2020 Feb;157(2):356-362. doi: 10.1016/j.chest.2019.09.005. Epub 2019 Sep 19.
- Individual participant dataSharing planned: No
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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.
Dr. 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 3 study testing Deep inhalation technique, Tidal breathing technique and Methacholine 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 6 inclusion and 6 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 15 May 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Effect of deep inhalation (versus tidal breathing) on mannitol provocative dose causing a 15% fall in forced expiratory volume in one second (FEV1) (time frame: 24 hours between mannitol challenges). 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 NCT03505489, which also lists 2 linked publications.
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 15 May 2019.