Role of Cigarette Smoking in Regulating Allergen-induced Early and Late Responses in Mild Asthmatics

NCT00626171 | Completed Early Phase 1

• 1 other identifier: ZMsmsp
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Asthma

Keywords

smoking; asthma; sputum

Outcome Measures

Primary Outcomes (1)

• To measure the number of inflammatory cells in induced sputum following allergen challenge in smoking and non-smoking asthmatic subjects.

  7h and 24 h post

Study Arms (1)

1

OTHER

Allergen challenge

Procedure: Allergen Challenge

Interventions

Allergen Challenge PROCEDURE

Allergen challenge

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with mild atopic asthma, presently well controlled on ß2-agonist only.
• Baseline FEV1 more than or equal to 70% of predicted normal.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Asthma; Smoking

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Study Officials

• Paul O'Byrne, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Gail Gauvreau, PhD

  McMaster University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paul O'Byrne

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

CA (1)