Study to assess efficacy & safety of doxofylline 400 mg twice daily versus doxofylline 800 mg ER once daily in the treatment of chronic obstructive pulmonary disease.

A open-labelled, prospective, randomized, two-arm, parallel group 4-week clinical study to assess efficacy & safety of doxophylline extended release 800 mg OD vs doxophylline 400 mg BD in the treatment of patients with chronic obstructive pulmonary disease.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000154

Enrollment

Unknown

Registered

2009-06-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Doxofylline Extended Release: 800 mg OD Control Intervention1: Doxofylline: 400 mg BD

Eligibility

Inclusion criteria

Inclusion criteria: Patients ³40 years, (male or non-pregnant female) Clinical diagnosis of stable COPD

Exclusion criteria

Exclusion criteria: Patients with severe COPD requiring oxygen therapy, COPD exacerbation in the 4 weeks prior to screening visit or untreated serious respiratory infectious disease History of hypersensitivity methylxanthines, doxofylline or any ingredients of study formulations History of asthma, allergic rhinitis, atopy, or an elevated blood eosinophil count Recent history of myocardial infarction, heart failure, or cardiac arrhythmia requiring treatment and uncontrolled hypertension, severe renal or hepatic disease, active peptic ulcer disease Pregnant or breastfeeding females Patients already part or being a part of any clinical study in previous 1 months Any reasons at the discretion of investigators does not allow patients to participate in study

Design outcomes

Primary

Measure	Time frame
Effect on FEV1 Effect on symptoms control Effect on quality of life Timepoint: 4-weeks	—

Secondary

Measure	Time frame
Safety of sustained release formulation Physician & Patients? Global assessment of efficacy & tolerability Timepoint: 4-weeks	—

Countries

India

Contacts

Public ContactRahul Rathod

Medical Advisor

rahulrathod@zyduscadila.com02224811700

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026

Study to assess efficacy &amp; safety of doxofylline 400 mg twice daily versus doxofylline 800 mg ER once daily in the treatment of chronic obstructive pulmonary disease.

Conditions

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Outcome results

Study to assess efficacy & safety of doxofylline 400 mg twice daily versus doxofylline 800 mg ER once daily in the treatment of chronic obstructive pulmonary disease.