Chronic respiratory condition Respiratory
Conditions
Interventions
• Tab. Deriphyllin 300 mg SR
• Tab. Deriphyllin 450 mg SR
• Tab. Deriphyllin Retard 150 mg
• Tab. Deriphyllin Retard 300 mg
Participants enrolled in this real-world observational study will be ad
deriphyllin is prescribed as part of routine clinical care. Data collection is purely observational and non-interventional.
Total duration of observation per participant: 12 weeks
Total duration of f
Sponsors
Zydus Healthcare Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged >18 years of either gender 2. Patients with respiratory conditions such as asthma, COPD, and other conditions who are receiving deriphyllin treatment at the discretion of the treating physician 3. Patients for whom deriphyllin is being newly initiated as an add-on to ongoing therapy and who have not received deriphyllin treatment prior to study enrollment
Exclusion criteria
Exclusion criteria: 1. Patients under 18 years of age 2. Patients with known hypersensitivity to theophylline, etofylline, or any other components of deriphyllin, or those using other methylxanthines (e.g., aminophylline) 3. Patients with significant cardiovascular conditions like arrhythmia, LVH with EF < 30%, and severe heart failure 4. Patients diagnosed with active peptic ulcers due to the potential exacerbation of gastrointestinal symptoms 5. Patients having a history of epilepsy or other seizure disorders 6. Patients with severe liver dysfunction 7. Pregnant and lactating females 8. Any other conditions which are not suitable for Deriphyllin treatment at the discretion of the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events/serious adverse events (SAEs): description, severity, seriousness, outcome and causality, measured using investigator assessment and spontaneous patient reporting, continuously monitored from baseline through all study visits | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Spirometry parameters: FEV1 (L), FEV1/FVC ratio (%), PEFR (L/min) measured using a calibrated spirometer at baseline to follow-up visits within 3 months of baseline 2. Distance walked (meters) in a standard 6-Minute Walk Test (6MWT) conducted per ATS guidelines at baseline to follow-up visits within 3 months of baseline 3. Symptom severity for COPD measured using mMRC dyspnea score (0–4) at baseline to follow-up visits within 3 months of baseline 4. COPD Assessment Test (CAT) at baseline to follow-up visits within 3 months of baseline 5. Asthma Control Test (ACT) at baseline to follow-up visits within 3 months of baseline 6. Clinician-assessed disease status (e.g., improved/stable/worsened) measured using Global Physician Assessment, investigator’s clinical judgment recorded in CRF at Visit 1 (within 3 months), visit 2 (within 3 months, if any) 7. Subject satisfaction score (e.g., on a 5-point Likert scale) at Visit 1 (within 3 months), Visit 2 (within 3 months, if any) 8. Vital signs: oxygen saturation (%), blood pressure (mmHg), pulse rate (bpm) measured using pulse oximeter and automated blood pressure monitor at baseline to follow-up visits within 3 months of baseline 9. Laboratory parameters: CBC (Hb, WBC, platelets, etc), liver enzymes: ALT, AST, GGT (U/L), serum bilirubin (mg/dL), serum creatinine (mg/dL) measured using standard automated laboratory assays from venous blood samples at baseline to follow-up visits within 3 months of baseline 10. 12-lead ECG tracing and interpretation measured using a standard ECG machine at baseline to follow-up visits within 3 months of baseline | — |
Countries
India
Contacts
Public ContactPrachi Sharma
Outcome results
None listed