A Phase 4 interventional study of Doxofylline and Procaterol in COPD, sponsored by Thammasat University. Completed at 1 site in Thailand. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by Thammasat University · Phase 4, Interventional, and Treatment
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:
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 20 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Thammasat University is the lead sponsor of 83 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Doxofylline 400 mg oral twice daily for 4 weeks
Drug: Doxofylline
Procaterol 50 mcg oral twice daily for 4 weeks
Drug: Procaterol
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.
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.
Forced expiratory volume in 1 second (FEV1)
Postbronchodilator FEV1
Time frame: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Forced vital capacity (FVC)
Postbronchodilator FVC
Time frame: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Forced expiratory flow at 25-75% of FVC (FEF25-75)
Postbronchodilator FEF25-75
Time frame: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
modified Medical Research Council (mMRC) score
Scores range from 0 to 4, with higher scores indicating a worse outcome
Time frame: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
COPD Assessment Test (CAT)
Scores range from 0 to 40, with higher scores indicating a worse outcome
Time frame: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Plan to share: Yes — Individual participant data (IPD) and documents will be available for sharing immediately after publication for a period of 2 years.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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