TARGETTargeting the small airways in asthma”

Phase 1

• Conditions: Asthma; MedDRA version: 17.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-001143-31-DK
• Lead Sponsor: Bispebjerg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-28
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Asthma diagnosed by at least one objective test within last 12 months:
?positive bronchial provocation test (mannitol or methacholine),
?reversibility to beta-2 agonist (> 12 %, and > 250 mL) or
?PEF variation (>20%)

With
1.Treated with daily ICS +/- LABA for at least 3 months
2.Partly controlled or uncontrolled asthma according to GINA guidelines definitions, and
3.Positive mannitol bronchial provocation test (PD15< 450 mg) at screening and after 4 week run-in.
4.Signs of eosinophilic airway inflammation (FeNO > 25 ppb)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Other lung diseases
2.Active smoking past 12 months
3.Ex-smokers (< 12 months: > 10 pack years)
4.Pregnancy or lactation
5.Respiratory infection (past 6 weeks)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified