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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210730002

Enrollment

Registered

2021-07-30

Start date

2021-08-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Bronchodilator Asthma Bronchodilator

Interventions

Doxofylline 400 mg oral 2 times/days for 2 weeks,Procaterol 50 mcg oral 2 times/days for 2 weeks

Experimental Drug,Active Comparator Drug

Doxofylline,Procaterol

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
FEV1 At the beginning of study, at week 2 liters,FEV1 At the beginning of study, at week 2 Percentage	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Thailand

Contacts

Public ContactNarongkorn Saiphoklang

Thammasat University

M_narongkorn@hotmail.com6629269794

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026