Does asthma phenotype have impact on disease control

Phase 1

• Conditions: Asthma; MedDRA version: 16.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2013-004905-15-DK
• Lead Sponsor: Respiratory Research Unit, Bispebjerg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-22
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Asthmatics with positiv mannitol
age 18-80
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 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

Other pulmonary disease

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the impact of asthma phenotype and disease control;Secondary Objective: Do patients receive a faster improvement in asthma control when controlled by NO measurement;Primary end point(s): Improvement of Airway hyperresponsiveness to Mannitol;Timepoint(s) of evaluation of this end point: 2 years from first patient

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Proving improvement of asthma when controlled by NO;Timepoint(s) of evaluation of this end point: 2 years