TCTR20210730002 TCTR 30/07/2021 Faculty of Medicine, Thammasat University Bronchodilator effect of oral doxofylline and procaterol in asthma: A randomized crossover study Bronchodilator effect of oral doxofylline and procaterol in asthma : A randomized crossover study 01/08/2021 Actual 20 Completed www.thaiclinicaltrials.org/show/TCTR20210730002 Interventional Randomized Phase 4 Asthma Bronchodilator Doxofylline 400 mg oral 2 times/days for 2 weeks,Procaterol 50 mcg oral 2 times/days for 2 weeks 21 31/12/2022 No No source of data sharing
public Narongkorn Saiphoklang
99/209 Paholyotin Road
Pathum Thani Thailand 12120 6629269794 M_narongkorn@hotmail.com Thammasat University scientific Narongkorn Saiphoklang
99/209 Paholyotin Road
Pathum Thani Thailand 12120 6629269794 M_narongkorn@hotmail.com Thammasat University Thailand 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) 18 Years N/A (No limit) Both 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 Asthma Bronchodilator Experimental Drug,Active Comparator Drug Doxofylline,Procaterol FEV1 At the beginning of study, at week 2 liters,FEV1 At the beginning of study, at week 2 Percentage 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 Nil Known Faculty of Medicine, Thammasat University Submitted, approved 19/07/2021 The Human Research Ethics Committee of Thammasat University (Medicine) 99/209 Paholyotin Road, Klong Luang, Pathum Thani, Thailand 12120 6629269704 Ext. 7535 ec.medtu@gmail.com