AsthmaEarly Phase 1NCT00625989
The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic Asthmatics
A Early Phase 1 study testing Aeroallergen in people with Asthma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Summary: A picture is emerging of dendritic cells migrating through the blood to the airways following allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present novel findings, both do not provide a comprehensive view of sputum DCs following allergen challenge. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Aeroallergen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Dec 2008
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 atopic 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
Summary:
A picture is emerging of dendritic cells migrating through the blood to the airways following allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present novel findings, both do not provide a comprehensive view of sputum DCs following allergen challenge. Therefore, the proposed study will examine the kinetics of mDCs and pDCs in the induced sputum of atopic asthmatics following inhalation of allergen.
Read more
Hypothesis:
Following allergen challenge, sputum myeloid and plasmacytoid DCs will migrate into the airway lumen in atopic asthmatics during the timeframe of the late asthmatic response.
Objective:
The objective of this study is to examine the kinetics of dendritic cells in induced sputum following allergen challenge in atopic asthmatic subjects.
Read the detailed description
Subjects will be put through two study periods. Each study period will consist of four visits and will be separated by 2-4 weeks. On the first visit, subjects will undergo screening procedures, including complete history and physical examination. In addition, methacholine inhalation challenge and skin-prick testing will be preformed to assess airway hyper-responsiveness and determine atopic status respectively. Lastly, sputum will be induced before challenge (0 hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7 hours following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood.
Before the next study period begins, there will be a washout period of 2-4 weeks. On the first visit of the second study period, a methacholine challenge will be performed to ensure the return of PC20 to within one doubling dose of baseline values. Also, sputum will be induced before challenge (0hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7hrs following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood.
- Conditions
- Asthma
- Being tested
- Aeroallergen
- Keywords
- asthma, atopy, allergen challenge, sputum myeloid and plasmacytoid dendritic cells
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeroallergenDrug
| Study group | Role | What they receive |
|---|---|---|
| Diluent | Placebo comparator | Inhalation challenge preformed with diluent. Receives: Drug: Aeroallergen |
| Allergen | Active comparator | Inhalation challenge preformed with allergen. Receives: Drug: Aeroallergen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells
Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.
Measured: 24 hrs
The Primary Outcome Measure for This Study is the Number of Sputum Plasmacytoid Dendritic Cells
Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.
Measured: 24 hrs
Secondary outcomes (4)
The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant.
Measured: Before inhalation (0hrs)
The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant
Measured: 7 hrs
The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant
Measured: 24 hrs
The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant
Measured: 72 hrs
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 startFeb 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul O'Byrne, MD, Principal investigator, McMaster UniversityGail Gauvreau, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625989
- Sponsor's protocol ID
- sputdend08
- Other IDs
- BDUA2008
- Status last verified
- Apr 2015
- First submitted
- 23 Jan 2008
- Last updated
- 21 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic Asthmatics
- ClinicalTrials.gov ID
- NCT00625989
- Acronym / sponsor ID
- sputdend08
- Conditions
- Asthma
- Keywords
- asthma, atopy, allergen challenge, sputum myeloid and plasmacytoid dendritic cells
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 15 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Summary:
A picture is emerging of dendritic cells migrating through the blood to the airways following allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present novel findings, both do not provide a comprehensive view of sputum DCs following allergen challenge. Therefore, the proposed study will examine the kinetics of mDCs and pDCs in the induced sputum of atopic asthmatics following inhalation of allergen.
Hypothesis:
Following allergen challenge, sputum myeloid and plasmacytoid DCs will migrate into the airway lumen in atopic asthmatics during the timeframe of the late asthmatic response.
Objective:
The objective of this study is to examine the kinetics of dendritic cells in induced sputum following allergen challenge in atopic asthmatic subjects.
Detailed description
Subjects will be put through two study periods. Each study period will consist of four visits and will be separated by 2-4 weeks. On the first visit, subjects will undergo screening procedures, including complete history and physical examination. In addition, methacholine inhalation challenge and skin-prick testing will be preformed to assess airway hyper-responsiveness and determine atopic status respectively. Lastly, sputum will be induced before challenge (0 hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7 hours following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood.
Before the next study period begins, there will be a washout period of 2-4 weeks. On the first visit of the second study period, a methacholine challenge will be performed to ensure the return of PC20 to within one doubling dose of baseline values. Also, sputum will be induced before challenge (0hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7hrs following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diluent | Placebo comparator | Drug: AeroallergenInhalation challenge preformed with diluent. |
| Allergen | Active comparator | Drug: AeroallergenInhalation challenge preformed with allergen. |
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 atopic 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 |
|---|---|---|
| Aeroallergen | Drug | Allergen, Diluent |
Primary outcome
The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells
Time frame: 24 hrs
Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.
The Primary Outcome Measure for This Study is the Number of Sputum Plasmacytoid Dendritic Cells
Time frame: 24 hrs
Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.
4 secondary outcomes
The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant.
Time frame: Before inhalation (0hrs)
The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant
Time frame: 7 hrs
The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant
Time frame: 24 hrs
The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant
Time frame: 72 hrs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 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 Early Phase 1 study testing Aeroallergen 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 May 2018. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells (time frame: 24 hrs). 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?
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 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.