Vitamin D for the Treatment of Severe Asthma

• Status: Unknown status
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators want to test the hypothesis, that vitamin D3 improves pulmonary function and quality of life in patients with asthma relatively resistant to glucocorticoids.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kantonsspital Baselland Bruderholz
• Collaborator: University Hospital, Basel, Switzerland
• Treatments: Calcitriol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 20 outpatients of either sex,

• ages ≥18 years, with a history of persistent asthma as defined by the American Thoracic Society (ATS) will be eligible for entry into the study.

• Additionally, patients must have been previously treated with ICS for at least 4 weeks at a stable dose equivalent to ≥400 ug/day beclomethasone dipropionate.

• Patients will be required to have a forced expiratory volume in 1 s (FEV1) between 40-85% of predicted normal before the use of an inhaled bronchodilator and to demonstrate at least one of the following:

• an improvement in FEV1 ≥ 12% and ≥ 200 ml within 15-30 min after inhalation of salbutamol 200-400 ug;

• airway hyperresponsiveness to methacholine causing a 20% decline in FEV1 (PC20 FEV1) at a concentration of < 16 mg/ml;

• diurnal peak expiratory flow (PEF) variability of ≥ 15% during at least 3 of 7 days before randomization.

Exclusion Criteria:

• Patients with either an exacerbation of asthma or respiratory tract infection within 6 weeks or admission to a hospital for asthma within 6 weeks before the study will be excluded.

• Also patients will not be eligible if they had > 3 nights with awakenings due to asthma that required treatment with short-acting betamimetics or had 3 days when they required > or = 12 puffs/d short-acting betamimetics during the 7days before the randomization visits.

• Patients will also excluded if they use medications greater potency than inhaled steroid, e.g.not leukotriene inhibitors or anti-IgE (Xolair®).

• Patients with chronic obstructive pulmonary disease and current or former smokers of >10 pack-years