severe asthma
Conditions
Interventions
Trade Name: Dekristol® 1000 I.E
Product Name: Dekristol® 1000 I.E
Product Code: A11CC05
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Colecalciferol
CAS Number: 67-97-0
Concentration unit: I
Sponsors
University Medical Center of the Johannes Gutenberg University Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Exacerbations (rate of and time to first and subsequent exacerbations) - ACQ-5 score, AQLQ score, BDI / TDI - FVC, FEV1, RV, TLC, airway resistance, IC, DLCO - Serum concentrations of vitamin D, parathormone, calcium, interleukins (IL) 10 and 17, as well as TNF-alpha - Proportion of patients that achieved vitamin D sufficiency (vitamin D responder: 25-hydroxyvitamin D level = 30 ng/mL) - Assessment of safety and tolerability by documentation of adverse events (AEs), serious adverse events (SAEs), vital signs, physical examination and laboratory parameters (laboratory test abnormalities/test value changes over time);Timepoint(s) of evaluation of this end point: week 4 week 8 week 12 week 14 week 18 week 20 week 24 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To investigate the effect of vitamin D as add-on therapy to inhaled or oral corticosteroids necessary to control asthma in vitamin D insufficient patients with severe disease;Primary end point(s): Relative dose reduction of ICS (µg beclomethasone or equivalent/day) or OCS (mg prednisone or equivalent/day) at the end of study phase II, defined as [initial dose at week 0 – dose at end of phase II (week 24)] / initial dose at week 0. If the dose at end of Phase II has been reduced compared to week 0 and this was followed by an exacerbation within 4 weeks after reduction, the dose before that reduction will be used for the calculation of relative dose reduction.;Timepoint(s) of evaluation of this end point: week 24;Secondary Objective: - To evaluate the effects on rate and time to first and subsequent exacerbations. - To evaluate the effects on a range of asthma-related clinical and functional Parameters (e.g. ACQ-5 score, AQLQ score, BDI / TDI, FVC, FEV1, RV, TLC, airway resistance, IC, DLCO, serum concentrations of vitamin D, parathormone, calcium, interleukins (IL) 10 and 17, and TNF-alpha | — |
Countries
Germany
Contacts
Public ContactStephanie Korn
University Medical Center of the Johannes Gutenberg University Mainz
Outcome results
None listed