Early Phase 1
N=12
The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic Asthmatics
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00625989 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells — 32800; 89100 number of cells/g of sputum
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Aeroallergen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hamilton Health Sciences Corporation
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells |
32800; 89100 | — |
| PRIMARY The Primary Outcome Measure for This Study is the Number of Sputum Plasmacytoid Dendritic Cells |
16000; 39900 | — |
| SECONDARY The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant. |
— | — |
| SECONDARY The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant |
— | — |
| SECONDARY The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant |
— | — |
| SECONDARY The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant |
— | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- Mild atopic asthmatics, presently well controlled on ß2-agonists.
- Non-smokers.
- Baseline FEV1 more than 70% of predicted normal.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00625989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.