AsthmaPhase 4NCT01288482
AeroEclipse II Agreement
A Phase 4 study testing AeroEclipse II breath-actuated nebulizer and English-Wright continuous-mode nebulizer in people with Asthma, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Traditional, continuous-mode nebulizers such as the English-Wright nebulizer are designed to operate continuously with tidal breathing. As inhalation accounts for only about one-third of the respiratory cycle, two-thirds of the continuously produced aerosol is lost to the environment possibly posing a hazard any… Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- AeroEclipse II breath-actuated nebulizer and English-Wright continuous-mode nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Sep 2011
- 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 10 to 65 years at time of recruitment into this study,
- Diagnosis of current asthma by a health care professional,
- Tidal breathing Provocation Concentration ≤ 16 mg/mL,
- Forced Expiratory Volume 1> 65% of predicted,
- No respiratory tract infection or allergen exposure ≥ 4 weeks,
- Able to complete 2 methacholine inhalation challenges on 2 separate days at the same time of day, at least 24-h apart, and within a 2-week period,
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- Inhaled salbutamol withheld for ≥8 hours prior to testing,
- Inhaled corticosteroid maintained at same dose throughout study,
- inhaled formoterol and salmeterol withheld for ≥36 hours prior to testing.
Who cannot join
- Those born prematurely (more than 4 weeks early of the calculated date),
- Those with chronic health conditions like diabetes or cystic fibrosis,
- Smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the AeroEclipse II Breath Actuated Nebulizer for the Delivery of Methacholine Chloride Bronchoprovocation Agent: A Pilot Study.
Traditional, continuous-mode nebulizers such as the English-Wright nebulizer are designed to operate continuously with tidal breathing. As inhalation accounts for only about one-third of the respiratory cycle, two-thirds of the continuously produced aerosol is lost to the environment possibly posing a hazard any fellow-patients, family members, or health-care workers in the vicinity. The English-Wright has been the only American Thoracic Society (ATS)recommended device available on the market. Recently Roxon Medi-Tech has announced the discontinuation of the English-Wright nebulizer. For these reasons it is necessary to review the use of other nebulizers such as the AeroEclipse II breath-actuated nebulizer and further validate their performance.
The investigators expect to show equivalence between the AeroEclipse II and the English-Wright nebulizers.
Read the detailed description
This study would like to determine if the use of the Aeroeclipse II breath actuated nebulizer for the delivery of methacholine chloride bronchoprovocation agent to the lungs results in the same Provocation Concentration PC20 (provocation concentration, or dose that causes a 20% decrease in Forced Expiratory Volume in 1 sec or FEV1) as using the English-Wright nebulizer for the delivery of methacholine chloride bronchoprovocation agent to the lungs.
- Conditions
- Asthma
- Being tested
- AeroEclipse II breath-actuated nebulizer, English-Wright continuous-mode nebulizer
- Keywords
- Methacholine challenge, nebulizer, English-Wright, AeroEclipse II
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeroEclipse II breath-actuated nebulizerDevice
The AeroEclipse II (Trudell Medicinal International, London, ON, Canada) is a breath-actuated nebulizer that allows for the creation of aerosol only in response to the patient's inspiratory flow, resulting in virtually no drug loss to the environment and providing a safer healthcare and patient environment by significantly reducing second-hand drug exposure and the possibility for transmission of viral airborne pathogens.
English-Wright continuous-mode nebulizerDevice
The English-Wright is a continuous-mode nebulizer, designed to operate continuously with tidal breathing, producing an aerosol which is lost to the environment possibly posing a hazard to any fellow-patients, family members, or health-care workers in the vicinity. It is the only device recommended by the American Thoracic Society guidelines that is available on the market and it has recently been discontinued. For these reasons it is necessary to review the use of other nebulizers and validate their performance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma Subjects | Experimental | Not described Receives: Device: AeroEclipse II breath-actuated nebulizer; Device: English-Wright continuous-mode nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine inhalation challenge
A methacholine inhalation challenges will be performed at each of the first two visits. At the first clinic visit each subject will be randomly assigned to use either the English-Wright continuous-mode nebulizer, or the AeroEclipse II breath actuated nebulizer. The alternate nebulizer will be used during the second clinic visit. The methacholine concentration producing a 20% decrease in Forced Expiratory Volume in 1 second (PC20) will be measured by way of a standard breathing challenge (the tidal breathing Cockcroft technique)
Measured: Visit 1(Day 1)
Methacholine inhalation challenge
A methacholine inhalation challenges will be performed at each of the first two visits. At the first clinic visit each subject will be randomly assigned to use either the English-Wright continuous-mode nebulizer, or the AeroEclipse II breath actuated nebulizer. The alternate nebulizer will be used during the second clinic visit. The methacholine concentration producing a 20% decrease in Forced Expiratory Volume in 1 second (PC20) will be measured by way of a standard breathing challenge (the tidal breathing Cockcroft technique)
Measured: Visit 2 (up to 2 weeks)
Secondary outcomes (1)
Methacholine challenge - Cumulative Effect
There exists the possibility that as a result of decreased nebulisation time, we may see some cumulative effect from shortening the time between doubling doses of methacholine. If there is a systematic difference between the English-Wright and the AeroEclipse II nebulizers, it will then be impossible to know if we have calculated the wrong dose or we are seeing a cumulative effect. Therefore we are proposing that the first 10 patients participate in a third visit to look for a cumulative effect.
Measured: Week 3 +/- 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Dell, The Hospital for Sick Children
- Investigators
- Sharon Dell, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288482
- Sponsor's protocol ID
- 1000019446
- Status last verified
- May 2014
- First submitted
- 28 Jan 2011
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dell SD, Bola SS, Foty RG, Marshall LC, Nelligan KA, Coates AL. Provocative dose of methacholine causing a 20% drop in FEV1 should be used to interpret methacholine challenge tests with modern nebulizers. Ann Am Thorac Soc. 2015 Mar;12(3):357-63. doi: 10.1513/AnnalsATS.201409-433OC.
PubMed 25575246
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the AeroEclipse II Breath Actuated Nebulizer for the Delivery of Methacholine Chloride Bronchoprovocation Agent: A Pilot Study.
- ClinicalTrials.gov ID
- NCT01288482
- Acronym / sponsor ID
- 1000019446
- Conditions
- Asthma
- Keywords
- Methacholine challenge, nebulizer, English-Wright, AeroEclipse II
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Feb 2011 (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.
Traditional, continuous-mode nebulizers such as the English-Wright nebulizer are designed to operate continuously with tidal breathing. As inhalation accounts for only about one-third of the respiratory cycle, two-thirds of the continuously produced aerosol is lost to the environment possibly posing a hazard any fellow-patients, family members, or health-care workers in the vicinity. The English-Wright has been the only American Thoracic Society (ATS)recommended device available on the market. Recently Roxon Medi-Tech has announced the discontinuation of the English-Wright nebulizer. For these reasons it is necessary to review the use of other nebulizers such as the AeroEclipse II breath-actuated nebulizer and further validate their performance.
The investigators expect to show equivalence between the AeroEclipse II and the English-Wright nebulizers.
Detailed description
This study would like to determine if the use of the Aeroeclipse II breath actuated nebulizer for the delivery of methacholine chloride bronchoprovocation agent to the lungs results in the same Provocation Concentration PC20 (provocation concentration, or dose that causes a 20% decrease in Forced Expiratory Volume in 1 sec or FEV1) as using the English-Wright nebulizer for the delivery of methacholine chloride bronchoprovocation agent to the lungs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma Subjects | Experimental | Device: AeroEclipse II breath-actuated nebulizer, Device: English-Wright continuous-mode nebulizer |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 10 to 65 years at time of recruitment into this study,
- Diagnosis of current asthma by a health care professional,
- Tidal breathing Provocation Concentration ≤ 16 mg/mL,
- Forced Expiratory Volume 1> 65% of predicted,
- No respiratory tract infection or allergen exposure ≥ 4 weeks,
Key exclusion criteria (3 listed)
- Those born prematurely (more than 4 weeks early of the calculated date),
- Those with chronic health conditions like diabetes or cystic fibrosis,
- Smokers.
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 |
|---|---|---|
| AeroEclipse II breath-actuated nebulizerThe AeroEclipse II (Trudell Medicinal International, London, ON, Canada) is a breath-actuated nebulizer that allows for the creation of aerosol only in response to the patient's inspiratory flow, resulting in virtually no drug loss to the environment and providing a safer healthcare and patient environment by significantly reducing second-hand drug exposure and the possibility for transmission of viral airborne pathogens. | Device | Asthma Subjects |
| English-Wright continuous-mode nebulizerThe English-Wright is a continuous-mode nebulizer, designed to operate continuously with tidal breathing, producing an aerosol which is lost to the environment possibly posing a hazard to any fellow-patients, family members, or health-care workers in the vicinity. It is the only device recommended by the American Thoracic Society guidelines that is available on the market and it has recently been discontinued. For these reasons it is necessary to review the use of other nebulizers and validate their performance. | Device | Asthma Subjects |
Primary outcome
Methacholine inhalation challenge
Time frame: Visit 1(Day 1)
A methacholine inhalation challenges will be performed at each of the first two visits. At the first clinic visit each subject will be randomly assigned to use either the English-Wright continuous-mode nebulizer, or the AeroEclipse II breath actuated nebulizer. The alternate nebulizer will be used during the second clinic visit. The methacholine concentration producing a 20% decrease in Forced Expiratory Volume in 1 second (PC20) will be measured by way of a standard breathing challenge (the tidal breathing Cockcroft technique)
Methacholine inhalation challenge
Time frame: Visit 2 (up to 2 weeks)
A methacholine inhalation challenges will be performed at each of the first two visits. At the first clinic visit each subject will be randomly assigned to use either the English-Wright continuous-mode nebulizer, or the AeroEclipse II breath actuated nebulizer. The alternate nebulizer will be used during the second clinic visit. The methacholine concentration producing a 20% decrease in Forced Expiratory Volume in 1 second (PC20) will be measured by way of a standard breathing challenge (the tidal breathing Cockcroft technique)
1 secondary outcome
Methacholine challenge - Cumulative Effect
Time frame: Week 3 +/- 1 week
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 13 May 2014.
- Derived from this study: PubMed 25575246Dell SD, Bola SS, Foty RG, Marshall LC, Nelligan KA, Coates AL. Provocative dose of methacholine causing a 20% drop in FEV1 should be used to interpret methacholine challenge tests with modern nebulizers. Ann Am Thorac Soc. 2015 Mar;12(3):357-63. doi: 10.1513/AnnalsATS.201409-433OC.
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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.
Sharon Dell, MD principal investigator
The Hospital for Sick Children, Toronto Canada
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 AeroEclipse II breath-actuated nebulizer and English-Wright continuous-mode nebulizer in people with Asthma, run by The Hospital for Sick Children 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 9 inclusion and 3 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 13 May 2014. 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 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?
Methacholine inhalation challenge (time frame: Visit 1(Day 1)). The study lists 2 primary outcomes in all. 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 NCT01288482, 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 13 May 2014.