AsthmaEarly Phase 1NCT00626171
Role of Cigarette Smoking in Regulating Allergen-induced Early and Late Responses in Mild Asthmatics
A Early Phase 1 study testing Allergen Challenge in people with Asthma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The objective of this study is to determine the effect of cigarette smoking on inflammatory cell recruitment to the lungs after an allergen challenge, in non-smoking and currently smoking mild asthmatic subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Allergen Challenge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to Jul 2009
- Phase
- Early Phase 1
- 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
- Subjects with mild atopic asthma, presently well controlled on ß2-agonist only.
- Baseline FEV1 more than or equal to 70% of predicted normal.
Who cannot join
- Past or present cardiovascular, renal, liver or endocrine disease.
- Airway infection during the last 4 weeks.
- Exacerbation during the last 4 weeks.
- Inhaled or oral steroids during the last 4 weeks.
- Anti-asthma medication other than inhaled and/or oral ß2-agonists during the last 4 weeks.
- Pregnant or lactating women or women actively seeking pregnancy or lack of adequate contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Evaluating the Role of Cigarette Smoking in Regulating Allergen-induced Early and Late Responses in Mild Asthmatics.
The objective of this study is to determine the effect of cigarette smoking on inflammatory cell recruitment to the lungs after an allergen challenge, in non-smoking and currently smoking mild asthmatic subjects.
When comparing non-smoking asthmatics to smoking asthmatics, do differential cell counts obtained from inflammatory cells in induced sputum after allergen challenge differ?
Read more
Will differential cell counts show a decline in inflammatory cells in the induced sputum of asthmatics who have refrained from smoking for eight weeks?
This study is a randomized, case-controlled study. The first part of the study requires smoking and non-smoking subjects who will attend 2 study periods of 3 consecutive days (triad). In each triad, they will be challenged with allergen or diluent by inhalation, in a random order, and each triad is separated by a washout period. In the second part of the study, current smokers will be invited to undergo another allergen challenge 8 weeks of smoking cessation.
Read the detailed description
10 non-smoking adult subjects and 10 smoking adult subjects with mild atopic asthma will be studied.
Part 1: On the first study day of the triad, subjects will undergo screening procedures, including complete history and physical examination. Methacholine inhalation challenge and allergen skin titration will be performed to determine the concentration of allergen required for inhalation. Sputum will be induced for baseline measurement of airway inflammatory cells. On the second day, subjects will inhale the allergen or diluent in randomized order, and spirometry will be measured for the next 7 hours. Sputum will be collected at 7 hours after challenge. On the third day, subjects will report to the lab 24 hours after allergen/diluent inhalation challenge. Sputum cells will be collected to measure the percentage of airway inflammatory cells, including eosinophils and neutrophils. After washout of 2-4 weeks, subjects will return to undergo diluent/allergen triad.
Part 2: Asthmatic smokers will be studied to investigate allergen-induced changes in inflammatory cell numbers after they quit smoking for a period of 8 weeks. Asthmatic smokers who were involved in the first part of the study will be asked if they would like to participate in this part of the study, and they will be provided with smoking cessation tools including nicorette gum and nicotine patches, to aid them in ceasing to smoke. At the beginning of the study period, the same procedures that occurred in part 1 will be performed to obtain initial baseline results- ie- history, physical examination, skin prick test, methacholine challenge and sputum induction. Throughout the 8 week period, subjects will be required to come in weekly to perform a carboxyhemoglobin test, to ensure that they have not been smoking that week. At the end of the 8 week period, an allergen challenge triad will be carried out (as was performed in Part 1 of the study). Those subjects who were not able to comply to the smoking cessation regime will still be included in the final measurements.
We hypothesize that inflammatory cell counts will be higher in the asthmatic smokers versus asthmatic non-smokers. We also hypothesize that subjects who quit smoking for the 8 week period will show a decline in inflammatory cell counts indicating an improvement in lung function.
We believe that the results of this novel study will provide greater insight into the inflammatory response in asthmatic smokers, and will suggest appropriate therapeutic approaches for control of asthma in smokers.
- Conditions
- Asthma
- Being tested
- Allergen Challenge
- Keywords
- smoking, asthma, sputum
- Medical subject headings
- Asthma, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen ChallengeProcedure or surgery
Allergen challenge
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Allergen challenge Receives: Procedure: Allergen Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the number of inflammatory cells in induced sputum following allergen challenge in smoking and non-smoking asthmatic subjects.
Measured: 7h and 24 h post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2009
- Study completionJul 2009
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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul O'Byrne, McMaster University
- Investigators
- Paul O'Byrne, MD, Principal investigator, McMaster UniversityGail Gauvreau, PhD, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626171
- Sponsor's protocol ID
- ZMsmsp
- Status last verified
- Apr 2013
- First submitted
- 20 Feb 2008
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Role of Cigarette Smoking in Regulating Allergen-induced Early and Late Responses in Mild Asthmatics.
- ClinicalTrials.gov ID
- NCT00626171
- Acronym / sponsor ID
- ZMsmsp
- Conditions
- Asthma
- Keywords
- smoking, asthma, sputum
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Feb 2008 (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 determine the effect of cigarette smoking on inflammatory cell recruitment to the lungs after an allergen challenge, in non-smoking and currently smoking mild asthmatic subjects.
When comparing non-smoking asthmatics to smoking asthmatics, do differential cell counts obtained from inflammatory cells in induced sputum after allergen challenge differ?
Will differential cell counts show a decline in inflammatory cells in the induced sputum of asthmatics who have refrained from smoking for eight weeks?
This study is a randomized, case-controlled study. The first part of the study requires smoking and non-smoking subjects who will attend 2 study periods of 3 consecutive days (triad). In each triad, they will be challenged with allergen or diluent by inhalation, in a random order, and each triad is separated by a washout period. In the second part of the study, current smokers will be invited to undergo another allergen challenge 8 weeks of smoking cessation.
Detailed description
10 non-smoking adult subjects and 10 smoking adult subjects with mild atopic asthma will be studied.
Part 1: On the first study day of the triad, subjects will undergo screening procedures, including complete history and physical examination. Methacholine inhalation challenge and allergen skin titration will be performed to determine the concentration of allergen required for inhalation. Sputum will be induced for baseline measurement of airway inflammatory cells. On the second day, subjects will inhale the allergen or diluent in randomized order, and spirometry will be measured for the next 7 hours. Sputum will be collected at 7 hours after challenge. On the third day, subjects will report to the lab 24 hours after allergen/diluent inhalation challenge. Sputum cells will be collected to measure the percentage of airway inflammatory cells, including eosinophils and neutrophils. After washout of 2-4 weeks, subjects will return to undergo diluent/allergen triad.
Part 2: Asthmatic smokers will be studied to investigate allergen-induced changes in inflammatory cell numbers after they quit smoking for a period of 8 weeks. Asthmatic smokers who were involved in the first part of the study will be asked if they would like to participate in this part of the study, and they will be provided with smoking cessation tools including nicorette gum and nicotine patches, to aid them in ceasing to smoke. At the beginning of the study period, the same procedures that occurred in part 1 will be performed to obtain initial baseline results- ie- history, physical examination, skin prick test, methacholine challenge and sputum induction. Throughout the 8 week period, subjects will be required to come in weekly to perform a carboxyhemoglobin test, to ensure that they have not been smoking that week. At the end of the 8 week period, an allergen challenge triad will be carried out (as was performed in Part 1 of the study). Those subjects who were not able to comply to the smoking cessation regime will still be included in the final measurements.
We hypothesize that inflammatory cell counts will be higher in the asthmatic smokers versus asthmatic non-smokers. We also hypothesize that subjects who quit smoking for the 8 week period will show a decline in inflammatory cell counts indicating an improvement in lung function.
We believe that the results of this novel study will provide greater insight into the inflammatory response in asthmatic smokers, and will suggest appropriate therapeutic approaches for control of asthma in smokers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Allergen ChallengeAllergen challenge |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with mild atopic asthma, presently well controlled on ß2-agonist only.
- Baseline FEV1 more than or equal to 70% of predicted normal.
Key exclusion criteria (6 listed)
- Past or present cardiovascular, renal, liver or endocrine disease.
- Airway infection during the last 4 weeks.
- Exacerbation during the last 4 weeks.
- Inhaled or oral steroids during the last 4 weeks.
- Anti-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 |
|---|---|---|
| Allergen ChallengeAllergen challenge | Procedure or surgery | 1 |
Primary outcome
To measure the number of inflammatory cells in induced sputum following allergen challenge in smoking and non-smoking asthmatic subjects.
Time frame: 7h and 24 h post
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 24 Apr 2013.
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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.
Paul O'Byrne, MD principal investigator
McMaster University
Gail Gauvreau, PhD study director
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Allergen Challenge 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 2 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 24 Apr 2013. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
To measure the number of inflammatory cells in induced sputum following allergen challenge in smoking and non-smoking asthmatic subjects. (time frame: 7h and 24 h post). 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 24 Apr 2013.