Overview

This trial is active, not recruiting.

Condition asthma
Treatments vitamin d3, placebo
Phase phase 4
Sponsor Johannes Gutenberg University Mainz
Collaborator German Federal Ministry of Education and Research
Start date June 2015
End date March 2017
Trial size 160 participants
Trial identifier NCT02424552, 2014-002363-15, 2014-003

Summary

The purpose of the EVITA trial is to compare the effects of vitamin D therapy with placebo on reducing the dose of inhaled or oral corticosteroids in patients with severe asthma and vitamin D insufficiency.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Initial single dose 100000 IU, beginning from the second day 4000 IU/day for 24 weeks
vitamin d3 Cholecalciferol
Initial single dose 100000 IU, beginning from the second day 4000 IU/day for 24 weeks.
(Placebo Comparator)
Amount of Placebo capsules corresponding to initial single dose of Vitamin D3, beginning from the second day amount of capsules corresponding to daily dose of Vitamin D for 24 weeks
placebo
Filling material: lactose monohydrate, cellulose, magnesium stearate

Primary Outcomes

Measure
relative dose reduction of ICS or OCS at week 24 as assessed by total ICS or OCS dose
time frame: 24 weeks

Secondary Outcomes

Measure
Exacerbations (rate of and time to first and subsequent exacerbations) as assessed by numbers of exacerbations
time frame: 24 weeks and 30 weeks
Asthma Control as assessed by ACQ score
time frame: at weeks 4, 8, 12, 14, 18, 20, 24, and 28
Asthma Quality of Life as assessed by the Mini-AQLQ score
time frame: at weeks 12, 18, 24 and 28
Pulmonary function test results as assessed by FEV1, FVC, IC, RV, TLC, and airway resistance
time frame: at weeks 4, 8, 12, 14, 18, 20, 24, and 28
Levels of vitamin D as assessed by serum concentrations
time frame: at weeks 12, 18, 24 and 28
Proportion of patients that achieved vitamin D sufficiency
time frame: at week 24
Assessment of safety and tolerability as assessed by number of adverse events
time frame: up to 30 weeks
Dyspnea as assessed by Baseline and Transition Dyspnea Indexes
time frame: at weeks 12, 18, 24 and 28

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male or female patients, age ≥ 18 years - A pulmonary specialist documented diagnosis of severe asthma according to the Global Initiative for Asthma and the German Asthma Network (GAN, www.german-asthma-net.de) - Treatment with long-acting β2-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 Stable asthma medication for ≥1 month prior to screening (≥4 months for omalizumab) - 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 Exclusion Criteria: - Patients on vitamin D substitution - Current smokers or ex-smokers with a smoking history of more than 10 pack-years - Pregnant or nursing women or women who intend to become pregnant during the study - Known impaired renal function (GFR < 30 ml/min) and history of physician-diagnosed nephrolithiasis - Use of other investigational drugs during the study or within 30 days of screening

Additional Information

Official title EVITA Trial: Effect of VItamin D as add-on Therapy for Vitamin D Insufficient Patients With Severe Asthma: a Randomized, Double-blind, Placebo-controlled Trial
Principal investigator Stephanie Korn, MD
Description Patients with severe asthma represent the greatest unmet medical need among the asthmatic population, in particular due to their high risk of severe exacerbations. A substantial proportion of these patients does not achieve asthma control despite even high-dose ICS and LABA treatment, necessitating add-on therapy. For these patients oral corticosteroids (OCS) are a preferred treatment modality, which will inevitably lead to severe side effects. A high Proportion of patients with severe Asthma are Vitamin D insufficient (< 30 ng/ml). It is therefore tempting to speculate that vitamin D substitution in vitamin D insufficient patients who continue to experience suboptimal asthma control on ICS and LABA or ICS/LABA plus OCS treatment may boost corticosteroid responsiveness, thereby potentially reducing corticosteroid dose requirements and improving key parameters of asthma control. The present study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of treatment with vitamin D at a dose of 4000 IU/day administered daily following a single loading dose of 100 000 IU upon study entry over a period of 24 weeks in patients with severe asthma and vitamin D insufficiency. During the study, all patients will remain on their existing maintenance asthma therapy throughout the study, in addition to the study treatment, while reducing inhaled or oral steroids according to study protocol. The study consists of a 2-week run-in period, a 24 week double-blind treatment period including a 12 week steroid stable phase and two steroid reduction phases, followed by a follow-up visit 4 weeks after last study medication intake. The active treatment arm in this study will be standard of care plus vitamin D (loading dose of 100 000 IU upon study entry, to be followed by 4000 IU/day for the rest of the study period) while the comparator arm will be standard of care plus placebo.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Johannes Gutenberg University Mainz.