Bronchodilator effect of oral doxofylline and procaterol in asthma: A randomized crossover study

Phase 4

Completed

• Conditions: AsthmaBronchodilator; Asthma; Bronchodilator

• Registration Number: TCTR20210730002
• Lead Sponsor: Faculty of Medicine, Thammasat University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-30
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Age 18 years or more, 2. asthma diagnosis based on criteria of Global Initiative for Asthma (GINA), 3. Treatment with inhaled corticosteroid (ICS) or ICS plus long-acting beta2-agonists (ICS/LABA)

Exclusion Criteria

1. Smoking 10 pack-years or more, 2. Inability to perform spirometry, 3. FEV1 50% or less, 4. Asthma exacerbation within 3 months, 5. Treatment with systemic corticosteroid within 3 months, 6. Treatment with monoclonal anti-IgE (omalizumab) within 3 months, 7. Treatment with Salbutamol, Procaterol, Theophylline, Doxofylline within 1 week, 8. One of the following diseases or conditions: lung fibrosis, cardiac arrhythmia, chronic kidney disease (GFR<50 mL/min), chronic liver disease (AST, ALT, bilirubin, alkaline phosphatase, or GGT 1.5 x upper limit of normal), active malignancy, uncontrolled hypertension (blood pressure 200/100 mmHg or more), thyrotoxicosis, 9. preganancy or lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FEV1 At the beginning of study, at week 2 liters,FEV1 At the beginning of study, at week 2 Percentage

Secondary Outcome Measures

Name	Time	Method
PEF At the beginning of study, at week 2 L/s,FVC At the beginning of study, at week 2 Percentage,FEF25-75 At the beginning of study, at week 2 L/s,FEV1/FVC At the beginning of study, at week 2 Percentage,Asthma Control Questionnaire-5 (ACQ-5) At the beginning of study, at week 2 Points,Asthma Control Test (ACT) At the beginning of study, at week 2 Points,Asthma exacerbation rate At the beginning of study, at week 2 events,Drug adverse event At the beginning of study, at week 2 events