Chronic Obstructive Pulmonary Disease MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
Barts Health NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Medical record diagnosis of COPD, emphysema or bronchitis • Post-bronchodilator FEV1 / FVC =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Current diagnosis of asthma • Known clinically significant bronchiectasis • Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for = 3 years • Any other condition that, in an investigator’s judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study • COPD requiring long-term oxygen therapy = 12 hours per day • Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone • Taking dietary supplement containing vitamin D up to 2 months before first dose of IMP • Treatment with any investigational medical product or device up to 4 months before first dose of IMP • Breastfeeding, pregnant or planning a pregnancy • Baseline corrected serum calcium > 2.65 mmol/L • Baseline serum creatinine > 125 micromol/L • URTI or COPD exacerbation up to 28 days before first dose of IMP • Inability to use spirometer • Inability to complete symptom diary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The co- primary outcome measures for the study are: 1. Time from randomisation to first moderate or severe COPD exacerbation. 2. Time from randomisation to first upper respiratory tract infection.;Main Objective: Does Vitamin D supplementation influence time to first moderate / severe exacerbation and time to first upper respiratory tract infection in patients with COPD?;Secondary Objective: 1.Does vitamin D supplementation influence other respiratory symptoms in patients with COPD? 2.Does vitamin D supplementation influence health service use in patients with COPD? 3.Does vitamin D supplementation influence risk of adverse events in patients with COPD? 4.Does vitamin D supplementation influence medication use in patients with COPD? 5.Does vitamin D supplementation influence lung function in patients with COPD? 6.Does vitamin D supplementation influence muscle strength in patients with COPD? 7.Does vitamin D supplementation influence quality of life in patients with COPD? 8.Does vitamin D supplementation influence economic outcomes including illness-related costs and days of absence from work in patients with COPD? | — |
Countries
United Kingdom
Outcome results
None listed