Effect of VItamin D as add-on Therapy for vitamin D insufficient patients with severe Asthma

Phase 1

• Conditions: severe asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-002363-15-DE
• Lead Sponsor: niversity Medical Center of the Johannes Gutenberg University Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-04
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Subjects meeting all of the following criteria will be considered for enrolment into the trial:
- Male or female, age = 18 years with a pulmonary specialist diagnosis of severe asthma according to the Global Initiative for Asthma (GINA 2014, www.ginasthma.org) and the German Asthma Net (GAN, www. German-asthmanet.de)
- Treatment with long-acting ß2-agonists (LABA) and inhaled corticosteroids (ICS) at a dose of at least 1000 µg beclomethasone (or equivalent) per day, chronic oral corticosteroid (OCS) use is allowed
- Asthma Control Questionnaire (ACQ-5) score = 1.5
- Vitamin D insufficiency as defined by a serum vitamin D concentration of <30 ng/ml but = 10 ng/ml at screening
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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Subjects presenting one of the following criteria will not be enrolled in the trial:
- Patients on vitamin D substitution
- Impaired renal function (GFR < 30 ml/min) and history of physician-diagnosed nephrolithiasis
- Within the past 4 weeks respiratory tract infection or asthma exacerbation requiring systemic corticosteroids or increase in systemic corticosteroids
- Chronic respiratory diseases (other than asthma)
- Current smokers or ex-smokers with a smoking history of more than 10 packyears

Study & Design

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