COPD
Conditions
Keywords
Chronic obstructive pulmonary disease, COPD, Bronchodilator, Doxofylline, Procaterol, Pulmonary function
Brief summary
The goal of this clinical trial is to determine if doxofylline and procaterol are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs. The main questions it aims to answer are: * Does doxofylline demonstrate a comparable bronchodilator effect to procaterol in COPD participants? * What medical problems do participants experience when taking doxofylline and procaterol?
Detailed description
This study is a randomized crossover study. COPD patients aged 40 years or older with stable disease were included. Each patient received 4 weeks of treatment with either doxofylline or procaterol followed by a 2-week washout period, and then 4 weeks of treatment with the other drug. Respiratory symptoms were assessed by modified Medical Research Council (mMRC) dyspnea scale and COPD Assessment Test (CAT). Pulmonary functions were assessed by spirometry with bronchodilator testing, and adverse events were recorded. Spirometry data including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and forced expiratory flow at 25-75% of FVC (FEF25-75) were also collected.
Interventions
DRUGDoxofylline
Each patient received 4 weeks of treatment with either doxofylline or procaterol followed by a 2-week washout period, and then 4 weeks of treatment with the other drug.
DRUGProcaterol
Each patient received 4 weeks of treatment with either doxofylline or procaterol followed by a 2-week washout period, and then 4 weeks of treatment with the other drug.
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Crossover randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC \< 70%) * Aged 40 years or older * Smoking 10 pack-years or more * Postbronchodilator FEV1 \< 80%
Exclusion criteria
* History of COPD exacerbation within 3 months * Oral or intravenous corticosteroid treatment within 6 weeks * Oral bronchodilators e.g. doxofylline, theophylline, procaterol, or salbutamol within 1 week before randomization * Asthma * Tracheostomy, invasive or noninvasive mechanical ventilation * Inability to perform spirometry or 6-minute walk test * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced expiratory volume in 1 second (FEV1) | At the day of randomization (week 0), week 4, week 6, and week 8 of the study | Postbronchodilator FEV1 |
| Forced vital capacity (FVC) | At the day of randomization (week 0), week 4, week 6, and week 8 of the study | Postbronchodilator FVC |
| Forced expiratory flow at 25-75% of FVC (FEF25-75) | At the day of randomization (week 0), week 4, week 6, and week 8 of the study | Postbronchodilator FEF25-75 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Medical Research Council (mMRC) score | At the day of randomization (week 0), week 4, week 6, and week 8 of the study | Scores range from 0 to 4, with higher scores indicating a worse outcome |
| COPD Assessment Test (CAT) | At the day of randomization (week 0), week 4, week 6, and week 8 of the study | Scores range from 0 to 40, with higher scores indicating a worse outcome |
Countries
Thailand
Outcome results
None listed