AsthmaNCT03491358
Inhaled Allergen Challenge Methodology: Assessment of a Vibrating Mesh Nebulizer for Allergen Administration
A study testing Wright jet nebulizer and Aerogen Solo in people with Asthma, run by University of Saskatchewan at 3 sites in Canada.
Trial summary
This study will assess the Aerogen Solo® (Solo®) vibrating mesh nebulizer as a potential new device for use in allergen challenge testing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Wright jet nebulizer and Aerogen Solo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesCanada
- Study dates
- 27 Nov 2018to 24 Jul 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- baseline FEV1 greater than or equal to 70%
- positive response to inhaled methacholine (i.e. PD20 less than 400mcg)
- evidence of atopy (i.e. positive skin prick test to an allergen that can be used for the inhalation challenge
- absence of respiratory infection for at least 4 weeks
- absence of allergen exposure (or other trigger of upper or lower respiratory symptoms) for at least 4 weeks
- current nonsmoker (ex-smoker allowed; case by case basis; investigator discretion)
- require only infrequent short-acting beta2 agonist (i.e. salbutamol or terbutaline) to treat/control asthma (i.e. no inhaled corticosteroid or combination therapies, no intranasal corticosteroid; anti-histamines etc.)
- general good health with no other medical condition, medication use or lifestyle activities that would influence the outcome of the allergen challenge
Who cannot join
- pregnant or lactating
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McMaster University
Hamilton, Ontario, L8N 3Z5
Laval University
Québec, Quebec, G1V 4G5
Asthma Research Lab - University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
This study will assess the Aerogen Solo® (Solo®) vibrating mesh nebulizer as a potential new device for use in allergen challenge testing.
Read the detailed description
This will be a multi-center, randomized, cross-over study utilizing the expertise of three Canadian academic centers (University of Saskatchewan, McMaster University, Laval University) that have been performing allergen inhalation challenges and other bronchoprovocation studies for more than forty years.
Each participant will be required to attend the research lab on five occasions (Visits 1-5). At Visit 1, study staff will provide an overview of the study purpose and procedure and answer any questions the participant may have. The individual will then provide consent if they wish to participate (i.e. sign the consent form). Skin prick testing to determine relevant allergen sensitivities and to determine which allergen extract will be used for the skin test endpoint (STE) and allergen inhalation challenge will then be performed. The participant will be randomized with respect to which nebulizer (Solo® or Wright) will be used first. The choice of nebulizer for the first participant will be via blinded draw. Subsequent nebulizer assignments will alternate. Participants will undergo the STE procedure and methacholine challenge testing (MCT) at visit 2; an allergen challenge will be done the next day at Visit 3 using the same nebulizer as was used for the MCT at Visit 2. Visits 4 and 5 will also be performed on consecutive days and will involve methacholine and allergen challenge testing, respectively, using the nebulizer that was not used at Visits 2 and 3. A minimum of two weeks must separate Visits 3 and 4.
- Conditions
- Asthma
- Being tested
- Wright jet nebulizer, Aerogen Solo
- Keywords
- vibrating mesh nebulizer, allergen challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wright jet nebulizerDevice
Roxon Medi-Tech, Montreal, QC, Canada
Aerogen SoloDevice
Aerogen Ltd., Galway, Ireland
| Study group | Role | What they receive |
|---|---|---|
| Wright jet nebulizer | Active comparator | Will employ the Wright jet nebulizer for use in an allergen challenge triad Receives: Device: Wright jet nebulizer |
| Solo vibrating mesh nebulizer | Experimental | Will employ the Aerogen Solo vibrating mesh device for use in an allergen challenge triad Receives: Device: Aerogen Solo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergen Solo EAR PD20 (provocative dose causing a 20% fall in forced expiratory volume, FEV1)
Record the dose of allergen required to induce a 20% fall in forced expiratory volume using the Solo device
Measured: Baseline
Secondary outcomes (1)
Predicted allergen Solo EAR PD20
Will be predicted using the standard equation that employs the STE and MCT results
Measured: Baseline (based on baseline methacholine challenge and skin test endpoint results)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start27 Nov 2018
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT03491358
- Sponsor's protocol ID
- SOLO ALLERGEN 18
- Status last verified
- Dec 2019
- First submitted
- 29 Mar 2018
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cockcroft DW, Davis BE, Blais CM, Boulet LP, Boulay ME, Villeneuve H, Gauvreau GM, O'Byrne PM, Howie KJ, Obminski CD. Use of a vibrating mesh nebulizer for allergen challenge. Allergy Asthma Clin Immunol. 2019 Nov 26;15:73. doi: 10.1186/s13223-019-0392-8. eCollection 2019.
PubMed 31788006
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Allergen Challenge Methodology: Assessment of a Vibrating Mesh Nebulizer for Allergen Administration
- ClinicalTrials.gov ID
- NCT03491358
- Acronym / sponsor ID
- SOLO ALLERGEN 18
- Conditions
- Asthma
- Keywords
- vibrating mesh nebulizer, allergen challenge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 9 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.
This study will assess the Aerogen Solo® (Solo®) vibrating mesh nebulizer as a potential new device for use in allergen challenge testing.
Detailed description
This will be a multi-center, randomized, cross-over study utilizing the expertise of three Canadian academic centers (University of Saskatchewan, McMaster University, Laval University) that have been performing allergen inhalation challenges and other bronchoprovocation studies for more than forty years.
Each participant will be required to attend the research lab on five occasions (Visits 1-5). At Visit 1, study staff will provide an overview of the study purpose and procedure and answer any questions the participant may have. The individual will then provide consent if they wish to participate (i.e. sign the consent form). Skin prick testing to determine relevant allergen sensitivities and to determine which allergen extract will be used for the skin test endpoint (STE) and allergen inhalation challenge will then be performed. The participant will be randomized with respect to which nebulizer (Solo® or Wright) will be used first. The choice of nebulizer for the first participant will be via blinded draw. Subsequent nebulizer assignments will alternate. Participants will undergo the STE procedure and methacholine challenge testing (MCT) at visit 2; an allergen challenge will be done the next day at Visit 3 using the same nebulizer as was used for the MCT at Visit 2. Visits 4 and 5 will also be performed on consecutive days and will involve methacholine and allergen challenge testing, respectively, using the nebulizer that was not used at Visits 2 and 3. A minimum of two weeks must separate Visits 3 and 4.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wright jet nebulizer | Active comparator | Device: Wright jet nebulizerWill employ the Wright jet nebulizer for use in an allergen challenge triad |
| Solo vibrating mesh nebulizer | Experimental | Device: Aerogen SoloWill employ the Aerogen Solo vibrating mesh device for use in an allergen challenge triad |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- baseline FEV1 greater than or equal to 70%
- positive response to inhaled methacholine (i.e. PD20 less than 400mcg)
- evidence of atopy (i.e. positive skin prick test to an allergen that can be used for the inhalation challenge
- absence of respiratory infection for at least 4 weeks
- absence of allergen exposure (or other trigger of upper or lower respiratory symptoms) for at least 4 weeks
Key exclusion criteria (1 listed)
- pregnant or lactating
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 jet nebulizerRoxon Medi-Tech, Montreal, QC, Canada | Device | Wright jet nebulizer |
| Aerogen SoloAerogen Ltd., Galway, Ireland | Device | Solo vibrating mesh nebulizer |
Primary outcome
Allergen Solo EAR PD20 (provocative dose causing a 20% fall in forced expiratory volume, FEV1)
Time frame: Baseline
Record the dose of allergen required to induce a 20% fall in forced expiratory volume using the Solo device
1 secondary outcome
Predicted allergen Solo EAR PD20
Time frame: Baseline (based on baseline methacholine challenge and skin test endpoint results)
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 10 Dec 2019.
- Derived from this study: PubMed 31788006Cockcroft DW, Davis BE, Blais CM, Boulet LP, Boulay ME, Villeneuve H, Gauvreau GM, O'Byrne PM, Howie KJ, Obminski CD. Use of a vibrating mesh nebulizer for allergen challenge. Allergy Asthma Clin Immunol. 2019 Nov 26;15:73. doi: 10.1186/s13223-019-0392-8. eCollection 2019.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wright jet nebulizer and Aerogen Solo in people with Asthma, run by University of Saskatchewan at 3 sites 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 8 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 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Allergen Solo EAR PD20 (provocative dose causing a 20% fall in forced expiratory volume, FEV1) (time frame: Baseline). 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 NCT03491358, 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 10 Dec 2019.