The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic Asthmatics

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00625989
First received: January 23, 2008
Last updated: October 21, 2009
Last verified: October 2009
  Purpose

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.


Condition Phase
Asthma
Phase 0

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic Asthmatics

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • The primary outcome measure for this study is the number of sputum dendritic cells. [ Time Frame: Before inhalation (0hrs) ] [ Designated as safety issue: No ]
  • The primary outcome measure for this study is the number of sputum dendritic cells [ Time Frame: 7 hrs ] [ Designated as safety issue: No ]
  • The primary outcome measure for this study is the number of sputum dendritic cells [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • The primary outcome measure for this study is the number of sputum dendritic cells [ Time Frame: 72 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome measure is the level of specific chemokines released in the sputum supernatant. [ Time Frame: Before inhalation (0hrs) ] [ Designated as safety issue: No ]
  • The secondary outcome measure is the level of specific chemokines released in the sputum supernatant [ Time Frame: 7 hrs ] [ Designated as safety issue: No ]
  • The secondary outcome measure is the level of specific chemokines released in the sputum supernatant [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • The secondary outcome measure is the level of specific chemokines released in the sputum supernatant [ Time Frame: 72 hrs ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Community sample

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625989

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Paul O'Byrne, MD McMaster University
Principal Investigator: Gail Gauvreau, PhD McMaster University
  More Information

No publications provided

Responsible Party: Paul O'Byrne, McMaster University
ClinicalTrials.gov Identifier: NCT00625989     History of Changes
Other Study ID Numbers: sputdend08, BDUA2008
Study First Received: January 23, 2008
Last Updated: October 21, 2009
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
asthma
atopy
allergen challenge
sputum myeloid and plasmacytoid dendritic cells

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 11, 2014