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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxofylline arm | Experimental | Doxofylline 400 mg oral twice daily for 4 weeks |
|
| Procaterol arm | Active Comparator | Procaterol 50 mcg oral twice daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxofylline | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in 1 second (FEV1) | Postbronchodilator FEV1 | At the day of randomization (week 0), week 4, week 6, and week 8 of the study |
| Forced vital capacity (FVC) | Postbronchodilator FVC | 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 | At the day of randomization (week 0), week 4, week 6, and week 8 of the study |
| Measure | Description | Time Frame |
|---|---|---|
| modified Medical Research Council (mMRC) score | Scores range from 0 to 4, with higher scores indicating a worse outcome | At the day of randomization (week 0), week 4, week 6, and week 8 of the study |
| COPD Assessment Test (CAT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narongkorn Saiphoklang, MD | Thammasat University Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Narongkorn Saiphoklang | Klongluang | Changwat Pathum Thani | 12120 | Thailand |
Individual participant data (IPD) and documents will be available for sharing immediately after publication for a period of 2 years.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C029797 | doxofylline |
| D017265 | Procaterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Crossover randomized controlled trial
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| Procaterol | 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. |
|
Scores range from 0 to 40, with higher scores indicating a worse outcome
| At the day of randomization (week 0), week 4, week 6, and week 8 of the study |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D006912 | Hydroxyquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |