The effect of treatment with high dose vitamin D on airway inflammation in non-atopic asthma - Vitamin D in non-atopic asthma

Conditions: on-atopic asthma

Registration Number: EUCTR2009-014523-23-NL

Lead Sponsor: Stichting longgeneeskunde Fryslan

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

- Outpatients with non-atopic asthma (GINA guideline, negative alatop)
- Age >= 18 yr
- Documented reversibility in FEV1 of >12% predicted OR airway hyperresponsiveness to inhaled methacholine

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with smoking history of > 10 packyears and persistent airflow obstruction (post bronchodilator FEV1 < 80%pred): excluded if reversibility in FEV1 < 12% predicted OR TLCO < 80%
- Pregnancy
- Use of vitamin D prior to this study
- Other pulmonary conditions
- History of kidney stones, sarcoidosis, malignancy.
- Hypercalcaemia (Ca > 2,60 mmol/l)

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 effect of supplementation of a single high dose of vitamin D (100.000 Eh) on the percentage of neutrophils in induced sputum in non-atopic asthmatic patients with a predominantly neutrophilic airway inflammation.<br><br>;Secondary Objective: To investigate the effect of supplementation of a single high dose of vitamin D on the percentage of eosinophils in induced sputum, extend of sinus disease as measured on CT-sinus, pulmonary function (FEV1), levels of exhaled nitric oxide (NO), quality of life (AQLQ), asthma control (ACQ), SNOT, and adverse events scores in these patients and to identify potential predictors of response.;Primary end point(s): The change in percentage of neutrophils in induced sputum before and 9 weeks after vitamin D administration.

Secondary Outcome Measures