Mepolizumab and exacerbation frequency in refractory eosinophilic asthma: a randomised, double blind, placebo controlled trial

Completed

• Conditions: Asthma; Respiratory

• Registration Number: ISRCTN75169762
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. 60 participants meeting American thoracic criteria for refractory asthma
2. On intensive corticosteroid therapy - either oral and/or inhaled
3. A history of two or more exacerbations of asthma requiring oral corticosteroid rescue therapy in one year
4. Evidence of persistent eosinophilic inflammation in sputum - sputum eosinophils greater than 3% of total cell count

Exclusion Criteria

1. Participants who do not meet American Thoracic Society criteria for severe asthma
2. Participants who have not demonstrated evidence of persistent eosinophilic airway inflammation (sputum eosinophil counts of greater than or equal to 3% of total cell count
3. Partcipants who are current smokers or who have a cumulative smoking history of greater than 15 pack years
4. Participants with significant co morbidity - including other symptomatic respiratory diagnoses, evidence of recurrent bacterial respiratory tract infections (greater than or equal to 2 per year), symptomatic ischaemic heart disease and mental health or other conditions that interfere with participant compliance with the study
5. Pregnant females or women of child bearing age not practising effective contraception during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified