N/A N=39

Inflammation and Corticosteroid Responsiveness in Severe Asthma

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00180661 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Lung Function FEV1 — 84.9; 59.9 % of predicted — p=0.001

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult · 18+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Lung Function FEV1	84.9; 59.9	0.001 sig
PRIMARY Suppression of Monocyte Activation and Alveolar Macrophage Activation by Dexamethasone Ex-vivo	30; 10	0.005 sig
PRIMARY Effect of Corticosteroids on Release of Cytokines From Macrophages	—	—
SECONDARY Exhaled NO	—	—
SECONDARY Biopsy Eosinophils	—	—
SECONDARY Sputum Eosinophils	—	—

Summary

Some patients with mild asthma may develop severe asthma. It is not known what makes patients with mild asthma become severe, and we plan to find out why this happens. Patients with severe asthma may have a different type of inflammation in the airway tubes. Patients with severe asthma do not get as much benefit from taking steroid inhalers or tablets compared to asthma patients with mild disease. The study hypothesis is that the inflammation in severe asthma is such that it makes steroids less effective in treating asthma. We will find out what possible abnormalities there are in the blood cells and the bronchoalveolar macrophage cells in the lungs of patients with severe asthma compared to those with mild or moderate asthma.

Eligibility Criteria

Inclusion Criteria

The final diagnosis of severe asthma will be made according to the screening steps we have set up. The definition will require the presence of one or both major criteria (treatment with continuous or near continuous oral corticosteroids and/or requirement for treatment with high dose inhaled steroids) and two minor criteria.

Patients who do not fit the criteria of severe asthma will not be entered into the study.

Age 18-60; both sexes.

For the investigation of fiberoptic bronchoscopy, other additional inclusion criteria will be imposed:

Post-bronchodilator FEV1 greater than 40% on the day of the bronchoscopy
No evidence of an exacerbation of asthma within the past 4 weeks.
Ability to cooperate with procedures
Ability to give consent
Current smokers, and ex-smokers with greater than 10 pack years history of smoking.

Exclusion criteria

Pregnancy or unreliable contraceptive measures in child-bearing woman. he bronchoscopist has determined the subject is clinically appropriate for bronchoscopy

Exclusion Criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00180661). 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.