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Effect of add-on doxofylline on symptom improvement in severe COPD exacerbation

Effect of Add-on Doxofylline on Symptom Improvement in Severe COPD exacerbation : A Double-blinded Randomized Controlled Trial.

Status
Unknown
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250217001
Enrollment
24
Registered
2025-02-17
Start date
2023-04-01
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

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

Interventions

Group A received standard care, which included short-acting beta-2 agonists or a combination of short-acting beta-2 agonists with short-acting anticholinergic drugs (administered via MDI with spacer o
Placebo Comparator Drug,Active Comparator Drug

Sponsors

none
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 90 Years

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

MeasureTime frame
the efficacy of doxofylline versus placebo 30 day mMRC, CAT , VAS score

Secondary

MeasureTime 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

Public ContactNathaorn Phuangsombut

Faculty of Medicine, Thammasat University, Rangsit, Pathum Thani12120, Thailand

lovelove_gammam@hotmail.com029269999

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026