Acute exacerbations of chronic obstructive pulmonary disease (COPD AE) represent a significant global healthcare burden. Doxofylline has been demonstrated to possess bronchodilatory and anti-inflammatory properties, as well as a steroid-sparing effect. However, there is limited data regarding the efficacy of oral doxofylline in the management of severe COPD exacerbations. COPD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. aged between 40 and 90 years, regardless of sex 2. who were diagnosed with COPD according to the GOLD 2023 definition 3.who were experiencing a severe acute exacerbation of COPD as specified by the GOLD 2023 criteria.
Exclusion criteria
Exclusion criteria: 1.history of allergic reactions to doxofylline or other xanthine derivatives 2.contraindications to doxofylline as specified in the drug's prescribing information 3.used doxofylline or any other xanthine derivative within the past month 4.uncontrolled liver, renal, or cardiac arrhythmia conditions. 5.significant cognitive impairment 6. history of arrhythmias, pregnant or breastfeeding women 7.presenting with severe acute asthma requiring intubation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the efficacy of doxofylline versus placebo 30 day mMRC, CAT , VAS score | — |
Secondary
| Measure | Time frame |
|---|---|
| Lung function 30 day spirometer,the rate of recurrence of acute exacerbations 30 days number of exercerbation after treatment,Inflammatory biomarkers 30 CRP,rate of hospitalization 30 number of hospitalization after treatment,side effect of doxofylline 30 sign and symptoms | — |
Countries
Thailand
Contacts
Faculty of Medicine, Thammasat University, Rangsit, Pathum Thani12120, Thailand