AsthmaNCT02965482
Investigation of Novel Procedure for Methacholine Challenge Testing
A study testing Wright Nebulizer and Aerogen Solo Nebulizer in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The study will compare a novel volumetric method (performed with the Aerogen Solo vibrating mesh nebulizer) with the standard two-minute tidal breathing protocol (performed with the Wright jet nebulizer) for methacholine challenge testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Wright Nebulizer and Aerogen Solo Nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 or older
- Stable asthma
- Baseline methacholine PC20 less than or equal to 16mg/mL
- Baseline lung function equal or greater than 65% of predicted FEV1
Who cannot join
- Use of long-acting bronchodilators within 7 days of visit 1
- Pregnant or nursing women
- Cardiovascular problems
- Upper respiratory tract infection within 4 weeks of visit 1
- Allergy-induced asthma exacerbation within 4 weeks of visit 1
Trial locations and contacts
1 site in 1 country.
Canada1 site
Asthma Research Lab - University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: Volumetric Versus Standard Two Minute Tidal Breathing Methodology for Methacholine Challenge Testing
The study will compare a novel volumetric method (performed with the Aerogen Solo vibrating mesh nebulizer) with the standard two-minute tidal breathing protocol (performed with the Wright jet nebulizer) for methacholine challenge testing. The results will then give an indication as to whether the novel technique accurately assesses a given dose of methacholine with the new Aerogen Solo device. In addition, the reproducibility of test results with each method will be examined. Altogether, the findings from this investigation may provide means for better standardization of current testing guidelines.
Read the detailed description
Fifteen asthmatics will be recruited and tested at the University of Saskatchewan for this randomized, two-way crossover study. Two testing methodologies will be performed, the volumetric method with the Aerogen Solo nebulizer and the two-minute tidal breathing method with the Wright nebulizer.
Participants will undergo four methacholine challenges plus a screening methacholine challenge. However, screening is omitted with participants who have completed a methacholine challenge in the last six months. Of the four study challenges, two will utilize the Wright nebulizer with the two-minute tidal breathing method outlined in the 1999 American Thoracic Society Guidelines for Methacholine Challenge Testing. The remaining two challenges will utilize the Aerogen Solo nebulizer with the volumetric method. The timing of the spirometric manoeuvers and the duration of each inhalation cycle will be consistent with both testing methods. Each challenge will be stopped when the participant's forced expiratory volume in 1 second (FEV1) drops by at least 20%. This allows determination of aPC20 (provocative concentration of methacholine causing a 20% fall in FEV1), which will be converted to aPD20 (provocative dose). A minimum 24-hour washout period between challenges will be used.
- Conditions
- Asthma
- Being tested
- Wright Nebulizer, Aerogen Solo Nebulizer
- Keywords
- methacholine, airway hyperresponsiveness
- Medical subject headings
- Asthma, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wright NebulizerDevice
Roxon Medi-Tech, Montreal, QC, Canada
Aerogen Solo NebulizerDevice
Aerogen Ltd., Galway, Ireland
| Study group | Role | What they receive |
|---|---|---|
| Aerogen Solo | Active comparator | Volumetric method of methacholine challenge testing performed using the Aerogen Solo nebulizer Receives: Device: Aerogen Solo Nebulizer |
| Wright | Active comparator | Two-minute tidal breathing method of methacholine challenge testing performed using the Wright nebulizer Receives: Device: Wright Nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine PD20 values of two nebulizers, each with a different testing protocol
Do the nebulizers produce similar responses at the same dose
Measured: 2 weeks
Secondary outcomes (1)
Comparability of PD20 values with a single nebulizer over two methacholine challenges
Does a nebulizer produce similar PD20 results with repeat testing
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017
- Study completionMar 2017
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT02965482
- Sponsor's protocol ID
- MCT-SOLOWRIGHT-13
- Status last verified
- Jun 2017
- First submitted
- 14 Nov 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Versus Standard Two Minute Tidal Breathing Methodology for Methacholine Challenge Testing
- ClinicalTrials.gov ID
- NCT02965482
- Acronym / sponsor ID
- MCT-SOLOWRIGHT-13
- Conditions
- Asthma
- Keywords
- methacholine, airway hyperresponsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 Nov 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 study will compare a novel volumetric method (performed with the Aerogen Solo vibrating mesh nebulizer) with the standard two-minute tidal breathing protocol (performed with the Wright jet nebulizer) for methacholine challenge testing. The results will then give an indication as to whether the novel technique accurately assesses a given dose of methacholine with the new Aerogen Solo device. In addition, the reproducibility of test results with each method will be examined. Altogether, the findings from this investigation may provide means for better standardization of current testing guidelines.
Detailed description
Fifteen asthmatics will be recruited and tested at the University of Saskatchewan for this randomized, two-way crossover study. Two testing methodologies will be performed, the volumetric method with the Aerogen Solo nebulizer and the two-minute tidal breathing method with the Wright nebulizer.
Participants will undergo four methacholine challenges plus a screening methacholine challenge. However, screening is omitted with participants who have completed a methacholine challenge in the last six months. Of the four study challenges, two will utilize the Wright nebulizer with the two-minute tidal breathing method outlined in the 1999 American Thoracic Society Guidelines for Methacholine Challenge Testing. The remaining two challenges will utilize the Aerogen Solo nebulizer with the volumetric method. The timing of the spirometric manoeuvers and the duration of each inhalation cycle will be consistent with both testing methods. Each challenge will be stopped when the participant's forced expiratory volume in 1 second (FEV1) drops by at least 20%. This allows determination of aPC20 (provocative concentration of methacholine causing a 20% fall in FEV1), which will be converted to aPD20 (provocative dose). A minimum 24-hour washout period between challenges will be used.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerogen Solo | Active comparator | Device: Aerogen Solo NebulizerVolumetric method of methacholine challenge testing performed using the Aerogen Solo nebulizer |
| Wright | Active comparator | Device: Wright NebulizerTwo-minute tidal breathing method of methacholine challenge testing performed using the Wright 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)
- Men and women aged 18 or older
- Stable asthma
- Baseline methacholine PC20 less than or equal to 16mg/mL
- Baseline lung function equal or greater than 65% of predicted FEV1
Key exclusion criteria (5 listed)
- Use of long-acting bronchodilators within 7 days of visit 1
- Pregnant or nursing women
- Cardiovascular problems
- Upper respiratory tract infection within 4 weeks of visit 1
- Allergy-induced asthma exacerbation within 4 weeks of visit 1
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 |
|---|---|---|
| Wright NebulizerRoxon Medi-Tech, Montreal, QC, Canada | Device | Wright |
| Aerogen Solo NebulizerAerogen Ltd., Galway, Ireland | Device | Aerogen Solo |
Primary outcome
Methacholine PD20 values of two nebulizers, each with a different testing protocol
Time frame: 2 weeks
Do the nebulizers produce similar responses at the same dose
1 secondary outcome
Comparability of PD20 values with a single nebulizer over two methacholine challenges
Time frame: 2 weeks
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 14 Jun 2017.
- 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.
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 study testing Wright Nebulizer and Aerogen Solo Nebulizer 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 5 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 14 Jun 2017. 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?
Methacholine PD20 values of two nebulizers, each with a different testing protocol (time frame: 2 weeks). 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 14 Jun 2017.