Molecular Mechanism of Asthma

NCT00180726 | Withdrawn DMC

• 1 other identifier: NHLI-MB-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the mechanisms whereby lung function is decreased in asthma and sensitivity to treatment. The hypothesis is that in diseases such as asthma, inflammatory cells (leukocytes) including eosinophils, macrophages and lymphocytes migrate to the lung and release either more or different types of inflammatory mediators and/or receptors compared to subjects without asthma, which are corticoid sensitive or insensitive. The objective of the study is to identify which genes are specifically expressed in important cells in patients with asthma with a view to identify novel targets for drug therapy.

Conditions

Asthma

Keywords

asthma, inflammatory, corticosteroid

Outcome Measures

Primary Outcomes (1)

• gene expression evaluated using mRNA

Secondary Outcomes (1)

• corticosteroid sensitivity

Interventions

Blood sampling, Endoscopic Bronchoscopy, Spirometry PROCEDURE

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Asthmatic Patients
• Stable asthmatics on beta-2 agonist alone not using more than 4 puffs per day
• Atopic as defined by positive skin prick tests to at least 2 common aeroallergens
• PC20 methacholine of \< 4 mg /ml
• Increase in FEV1 \> 15% following beta-2 agonist inhalation, either at the time of study or previously documented
• Age 21-55 years of both sexes (females will be taking adequate contraceptive measures)
• Non-smokers
• Normal chest x-ray (CXR) and electrocardiogram (ECG) within the last 6 months.
• Healthy Non-Asthmatic Subjects
• All normal volunteers will meet the following criteria:
• Age 21-70 years of both sexes (females will be taking adequate contraceptive measures)
• No history of respiratory or allergic disease e.g. PC20 methacholine of \> 64mg/ml and negative skin prick tests
• Non-atopic with negative skin prick tests to common aeroallergens
• Normal baseline spirometry as predicted for age, sex and height.
• Non-smokers

You may not qualify if:

• Clinically significant findings in the medical history or on physical examination other than those of asthma in the asthma group.
• Lung function FEV1 \<30%
• Pregnant women or mothers who are breastfeeding.
• Patients who smoke
• Upper respiratory infection within the last 4 weeks
• Allergy to local anaesthetic
• Subjects who are unable to give informed consent.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Airway Disease, NHLI, Imperial College

London, SW3 6LY, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ian M Adcock, PhD

  NHLI, Imperial College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: December 1, 2003
• Study Completion: July 1, 2007
• Last Updated: May 9, 2019

Record last verified: 2019-05

Locations

GB (1)