Assessment of bronchial hyperresponsiveness in children - inhalation of Mannitol compared to eucapnic voluntary hyperventilation and methacholine provocatio

Conditions: Three different methods to assess airway hyperresponsiveness in children with allergic asthma will be compared.

Registration Number: EUCTR2007-003543-67-SE

Lead Sponsor: Karolinska Universitetssjukhuset

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Chidren =6 and =12 years with diagnosis of asthma verified by a paediatrician
- Asthma severity corrresponding to level 1,2 or 3 according to the Swedish Paediatric Society´s classification (intermittent or mild persistent).
- Asthma control corresponding to level A or B according to the Swedish Paediatric Society´s classification.
- Allergy confirmed through RAST or skin prick test.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- FEV1< 70% predicted on spirometry
- Respiratory tract infection within 4 weeks before the bronchial challenge tests.
- Exposure to allergens to which the child is sensitized within 2 days
- The child not beeing able to perform an adequate spirometry

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to compare three different methods to assess airway hyperresponsiveness in children with allergic asthma:<br>- Inhalationof dry powder mannitol<br>- Eucapnic voluntary hyperventilation with dry air <br>- Methacholine provocation test;Secondary Objective: - To investigate how exhaled NO differs before and after the bronchial challenges tests<br>- To assess the patients subjective experience of the different tests, particularly the perception of dyspnea<br>- To generate hypothesis for further studies within the area for instance specificity, applying the test on patients with severe asthma, monitoring response to treatment;Primary end point(s):

Secondary Outcome Measures