AsthmaNCT00529477
The Effects Of Methacholine Challenge Administered Using Three Different Nebulizers On Small Airways Function
A study testing 1. Wright Nebulizer, Pari LC Nebulizer and The Pari Sinustar Nebulizer in people with Asthma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The objective of this study is to examine the functional effects of methacholine challenge on small airways using three different nebulizers to generate particles with HMAD suitable for distribution in small, intermediate and large airways.Pulmonary function will be assessed using plethysmography and impulse… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- 1. Wright Nebulizer, Pari LC Nebulizer and The Pari Sinustar Nebulizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Apr 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild asthmatics, presently well controlled on ß2-agonists.
- Non-smokers.
- Baseline FEV1 more than 70% of predicted normal.
Who cannot join
- Airway infection during the last 4 weeks.
- Exacerbation during the last 4 weeks.
- Inhaled or oral steroids during the last 4 weeks.
- Antihistamines during the last 48 hours.
- Asthma medication other than inhaled and/or oral ß2-agonists during the last 4 weeks.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Methacholine Challenge Administered Using Three Different Nebulizers on Small Airways Function
The objective of this study is to examine the functional effects of methacholine challenge on small airways using three different nebulizers to generate particles with HMAD suitable for distribution in small, intermediate and large airways.Pulmonary function will be assessed using plethysmography and impulse oscillation techniques. Eight asthmatic subjects (>18 years, both sexes) who are stable clinically and require only intermittent ß2-agonist treatment will be recruited to undergo methacholine challenges for an in vivo, dose-finding observational study. Three separate methacholine challenges will be carried out using each of the three different nebulizers. After each challenge, pulmonary function tests will be performed on subjects to assess functional changes in large and small airways. Results of the tests will be compared between the three nebulizers. These experiments will demonstrate whether or not functional changes occur in small airways in response to methacholine, as measured by pulmonary function tests after selectively targeting small airways using the nebulizer which generates small particles. The results from these experiments will give us a better understanding of the role of small airways in methacholine-induced bronchoconstriction in asthmatics, and will compare sensitivity of plethysmography compared to forced oscillation for detecting changes in small airways.
Read the detailed description
This study will measure changes in small airways by plethysmography and impulse oscillation following delivery of methacholine using nebulizers designed to deliver to the small (Wright), intermediate (PARI LC® Plus) and large (PARI SinuStar™ ) airways.
Assessment of small airways involvement by plethysmography will include Residual Volume (RV), Forced Vital Capacity (FVC) and Peak Inspiratory and Expiratory Flow rates (PIF and PEF, respectively). Impulse oscillation will include measures of large and small airways resistance.
Baseline Spirometry
Baseline FEV1 and VC will be registered using a water spirometer.
Methacholine Challenge (Screening)
Methacholine inhalation will be performed as described by Cockcroft (1996). Subjects are instructed to wear noseclips and to breathe normally from the mouthpiece during the 2-minute inhalation period. Subjects inhale normal saline, then doubling concentrations of methacholine from a Wright nebulizer for 2 minutes each. FEV1 is measured at 30, 90, 180 and 300 seconds after each inhalation. Spirometry is measured with a Collins water sealed spirometer and kymograph. The test is terminated when a fall in FEV1 of 20% of the baseline value occurs, and the methacholine PC20 is calculated.
Methacholine Challenge
During the second visit, subjects will be randomized to inhale from a nebulizer that generates particles with HMAD suitable for distribution either in small, intermediate or large airways. Subjects will inhale doubling concentrations of methacholine for 2 minutes each. Immediately after each inhalation, pulmonary function tests will be performed on the subjects via plethysmography. Measurements will be made at intervals of 30 seconds, 60 seconds, 3 minutes and 5 minutes (or until a fall in FEV1 of 20% or more of baseline is reached). The methacholine test is terminated when a fall in FEV1 of 20% or more of the baseline value is reached. After a recovery time of 1 hour, the same doses will be re-administered and pulmonary function tests will again be performed, this time via impulse oscillation. The same procedure will be repeated for the third and fourth visits with the remaining nebulizers (selected randomly). The nebulizers that will be used to target certain airways are the Wright nebulizer (small), the PARI LC® Plus nebulizer (medium) and the PARI SinuStar™ nebulizer (large).
Plethysmography
Pulmonary function tests will be performed on subjects after methacholine challenges via plethysmography. Various tests will be performed that will allow for different lung function measures. To characterize which measurements are indicative of large or small airways function, measurements from the three nebulizer groups will be compared. Potential measures of small airway function include Functional Residual Capacity (FRC), Residual Volume (RV), Forced Vital Capacity (FVC) and Peak Inspiratory and Expiratory Flow Rates (PIF and PEF, respectively) (Knudson et al., 1980). Nitrogen washout will also be performed with the body box to measure airway distensibility, or the relationship between airway caliber and lung volume (Brown et al., 2004).
Impulse Oscillation
Pulmonary function tests will be performed on subjects after methacholine challenges via impulse oscillation. This device uses a loudspeaker to generate pressure and flow and by generating these at various frequencies, specifically differentiates between large and small airways obstruction (Otis et al., 1956). Results will be compared between the three nebulizer groups after specifically targeting certain airways.
- Conditions
- Asthma
- Being tested
- 1. Wright Nebulizer, Pari LC Nebulizer, The Pari Sinustar Nebulizer
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Wright NebulizerOther
The Wright nebulizer will be used to perform the methacholine challenge.
Pari LC NebulizerOther
The Pari LC nebulizer will be used to perform the methacholine challenge.
The Pari Sinustar NebulizerOther
The Pari Sinustar nebulizer will be used to perform the methacholine challenge.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The Wright Nebulizer will be used to perform the methacholine challenge in arm 1. Receives: Other: 1. Wright Nebulizer |
| 2 | Active comparator | The Pari LC nebulizer will be used to perform the methacholine challenge in arm 2. Receives: Other: Pari LC Nebulizer |
| 3 | Active comparator | The Pari Sinustar nebulizer will be used to perform the methacholine challenge in arm 3. Receives: Other: The Pari Sinustar Nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the functional effects of methacholine challenge on small airways via plethysmography and impulse oscillation techniques
Measured: April 2008
To compare the sensitivity of these measurement techniques to detect changes in small airways.
Measured: April 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionApr 2008
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Kieran Killian, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529477
- Sponsor's protocol ID
- NEB3-AIR
- Status last verified
- Oct 2009
- First submitted
- 7 Sep 2007
- Last updated
- 21 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Naji N, Keung E, Beaudin S, Kane J, Killian KJ, Gauvreau GM. The effects of particle size on measurement of airway hyperresponsiveness to methacholine. Ann Allergy Asthma Immunol. 2013 May;110(5):359-63. doi: 10.1016/j.anai.2013.02.014. Epub 2013 Mar 19.
PubMed 23622007
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Methacholine Challenge Administered Using Three Different Nebulizers on Small Airways Function
- ClinicalTrials.gov ID
- NCT00529477
- Acronym / sponsor ID
- NEB3-AIR
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Sep 2007 (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 objective of this study is to examine the functional effects of methacholine challenge on small airways using three different nebulizers to generate particles with HMAD suitable for distribution in small, intermediate and large airways.Pulmonary function will be assessed using plethysmography and impulse oscillation techniques. Eight asthmatic subjects (>18 years, both sexes) who are stable clinically and require only intermittent ß2-agonist treatment will be recruited to undergo methacholine challenges for an in vivo, dose-finding observational study. Three separate methacholine challenges will be carried out using each of the three different nebulizers. After each challenge, pulmonary function tests will be performed on subjects to assess functional changes in large and small airways. Results of the tests will be compared between the three nebulizers. These experiments will demonstrate whether or not functional changes occur in small airways in response to methacholine, as measured by pulmonary function tests after selectively targeting small airways using the nebulizer which generates small particles. The results from these experiments will give us a better understanding of the role of small airways in methacholine-induced bronchoconstriction in asthmatics, and will compare sensitivity of plethysmography compared to forced oscillation for detecting changes in small airways.
Detailed description
This study will measure changes in small airways by plethysmography and impulse oscillation following delivery of methacholine using nebulizers designed to deliver to the small (Wright), intermediate (PARI LC® Plus) and large (PARI SinuStar™ ) airways.
Assessment of small airways involvement by plethysmography will include Residual Volume (RV), Forced Vital Capacity (FVC) and Peak Inspiratory and Expiratory Flow rates (PIF and PEF, respectively). Impulse oscillation will include measures of large and small airways resistance.
Baseline Spirometry
Baseline FEV1 and VC will be registered using a water spirometer.
Methacholine Challenge (Screening)
Methacholine inhalation will be performed as described by Cockcroft (1996). Subjects are instructed to wear noseclips and to breathe normally from the mouthpiece during the 2-minute inhalation period. Subjects inhale normal saline, then doubling concentrations of methacholine from a Wright nebulizer for 2 minutes each. FEV1 is measured at 30, 90, 180 and 300 seconds after each inhalation. Spirometry is measured with a Collins water sealed spirometer and kymograph. The test is terminated when a fall in FEV1 of 20% of the baseline value occurs, and the methacholine PC20 is calculated.
Methacholine Challenge
During the second visit, subjects will be randomized to inhale from a nebulizer that generates particles with HMAD suitable for distribution either in small, intermediate or large airways. Subjects will inhale doubling concentrations of methacholine for 2 minutes each. Immediately after each inhalation, pulmonary function tests will be performed on the subjects via plethysmography. Measurements will be made at intervals of 30 seconds, 60 seconds, 3 minutes and 5 minutes (or until a fall in FEV1 of 20% or more of baseline is reached). The methacholine test is terminated when a fall in FEV1 of 20% or more of the baseline value is reached. After a recovery time of 1 hour, the same doses will be re-administered and pulmonary function tests will again be performed, this time via impulse oscillation. The same procedure will be repeated for the third and fourth visits with the remaining nebulizers (selected randomly). The nebulizers that will be used to target certain airways are the Wright nebulizer (small), the PARI LC® Plus nebulizer (medium) and the PARI SinuStar™ nebulizer (large).
Plethysmography
Pulmonary function tests will be performed on subjects after methacholine challenges via plethysmography. Various tests will be performed that will allow for different lung function measures. To characterize which measurements are indicative of large or small airways function, measurements from the three nebulizer groups will be compared. Potential measures of small airway function include Functional Residual Capacity (FRC), Residual Volume (RV), Forced Vital Capacity (FVC) and Peak Inspiratory and Expiratory Flow Rates (PIF and PEF, respectively) (Knudson et al., 1980). Nitrogen washout will also be performed with the body box to measure airway distensibility, or the relationship between airway caliber and lung volume (Brown et al., 2004).
Impulse Oscillation
Pulmonary function tests will be performed on subjects after methacholine challenges via impulse oscillation. This device uses a loudspeaker to generate pressure and flow and by generating these at various frequencies, specifically differentiates between large and small airways obstruction (Otis et al., 1956). Results will be compared between the three nebulizer groups after specifically targeting certain airways.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: 1. Wright NebulizerThe Wright Nebulizer will be used to perform the methacholine challenge in arm 1. |
| 2 | Active comparator | Other: Pari LC NebulizerThe Pari LC nebulizer will be used to perform the methacholine challenge in arm 2. |
| 3 | Active comparator | Other: The Pari Sinustar NebulizerThe Pari Sinustar nebulizer will be used to perform the methacholine challenge in arm 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild asthmatics, presently well controlled on ß2-agonists.
- Non-smokers.
- Baseline FEV1 more than 70% of predicted normal.
Key exclusion criteria (6 listed)
- Airway infection during the last 4 weeks.
- Exacerbation during the last 4 weeks.
- Inhaled or oral steroids during the last 4 weeks.
- Antihistamines during the last 48 hours.
- Asthma medication other than inhaled and/or oral ß2-agonists during the last 4 weeks.
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 |
|---|---|---|
| 1. Wright NebulizerThe Wright nebulizer will be used to perform the methacholine challenge. | Other | 1 |
| Pari LC NebulizerThe Pari LC nebulizer will be used to perform the methacholine challenge. | Other | 2 |
| The Pari Sinustar NebulizerThe Pari Sinustar nebulizer will be used to perform the methacholine challenge. | Other | 3 |
Primary outcome
To examine the functional effects of methacholine challenge on small airways via plethysmography and impulse oscillation techniques
Time frame: April 2008
To compare the sensitivity of these measurement techniques to detect changes in small airways.
Time frame: April 2008
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 21 Oct 2009.
- Derived from this study: PubMed 23622007Naji N, Keung E, Beaudin S, Kane J, Killian KJ, Gauvreau GM. The effects of particle size on measurement of airway hyperresponsiveness to methacholine. Ann Allergy Asthma Immunol. 2013 May;110(5):359-63. doi: 10.1016/j.anai.2013.02.014. Epub 2013 Mar 19.
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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.
Kieran Killian, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. Wright Nebulizer, Pari LC Nebulizer and The Pari Sinustar Nebulizer in people with Asthma, run by Hamilton Health Sciences Corporation 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 3 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 21 Oct 2009. 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?
To examine the functional effects of methacholine challenge on small airways via plethysmography and impulse oscillation techniques (time frame: April 2008). 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 NCT00529477, 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 21 Oct 2009.