Status:
UNKNOWN
Vitamin D for the Treatment of Severe Asthma
Lead Sponsor:
Kantonsspital Baselland Bruderholz
Collaborating Sponsors:
University Hospital, Basel, Switzerland
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed Description
Glucocorticoids are the first-line antiinflammatory treatment for asthma. Their multiple inhibitory properties, including the inhibition of Th2 cytokine synthesis, are likely to contribute to clinical...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00712205
Start Date
August 1 2008
End Date
August 1 2010
Last Update
August 13 2009
Active Locations (1)
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1
Department of Medicine
Bruderholz, Basel-Landschaft, Switzerland, 4101