Theophylline Etofylline Combination in Large Indian DRWE Study Presented at NAPCON 2025: Top 5 Takeaways

The NAPCON 2025 Jaipur and Patna session on real-world respiratory management focused on the clinical value of oral bronchodilator therapy in India, particularly the combination of etofylline plus theophylline as an add-on option in obstructive airway diseases. With a rising COPD burden and persistent symptom control challenges, the session highlighted the importance of patient-centric, evidence-driven decision-making, especially in settings where inhaler technique, adherence, and affordability could limit optimal outcomes.

Findings from the Latest DRWE Real World Evidence Study

During the session at Patna, Dr. Agam Vora presented the complete findings of the multicentre real-world study titled “Evaluating the Safety and Effectiveness of the combination of etofylline plus theophylline in Respiratory Disorders,” conducted across 400 sites and involving nearly 4,000 patients in India. The study included patients with asthma, COPD, bronchitis, cough, post-tuberculosis obstructive airway disease, and other respiratory indications, with clinically meaningful improvements observed within six weeks.

A major improvement in breathlessness was noted, with a 93% improvement in modified Medical Research Council (mMRC) grade from baseline to the end of six weeks. Among COPD patients, COPD Assessment Test (CAT) scores reduced from 30 to 9.32, indicating marked symptom relief and improvement in quality of life. In asthma patients, Asthma Control Test (ACT) scores improved from 12.5 to 20.9, reflecting better symptom control. Patient satisfaction and clinician evaluation were high, with 98.5% patients and 95.04% physicians rating the treatment between excellent to good.

Importantly, safety findings were reassuring, as ECG monitoring showed normal sinus rhythm with no arrhythmias or conduction disturbances across multiple time points, and no major side effects were reported. Etofylline plus theophylline combination was well tolerated.

Top 5 Key Takeaways

1.Obstructive Airway Diseases Remain Symptom-driven, Requiring Oral Add-on Treatment

Asthma COPD often overlaps, and is challenging to manage in the real world. COPD continues to be a high-burden, breathlessness-driven disease, and many patients remain symptomatic despite inhaled therapy—making individualized escalation strategies important.

2. Real World Barriers: Inhaler technique and adherence

The session reinforced that outcomes in asthma and COPD are strongly influenced by practical challenges such as inhaler technique, adherence, and access—factors that often determine whether patients benefit fully from prescribed inhaler-based therapy.

3. Theophylline Etophylline Combination: Large an RWE

The multicentre data showed early and significant improvement in breathlessness and validated symptom scores (CAT and ACT), reinforcing the real-world effectiveness of the combination of etofylline plus theophylline within six weeks in Indian patient population.

4. Reaffirmed Cardiac safety with Theophylline Etophylline Combination

The latest DRWE study reported reassuring cardiac safety signals, supported by ECG monitoring showing normal sinus rhythm and no arrhythmias or conduction abnormalities.

5. Theophylline Etophylline Combination: Practical Considerations

The session highlighted a clear place for oral bronchodilator add-on therapy in selected patients, including those with persistent symptoms, chronic bronchitis phenotypes, mild frequent exacerbations, affordability constraints, poor inhaler technique, severe COPD requiring stronger symptom control, and at hospital discharge alongside inhalers.

Expert Pulmonologists’ Insights from Panel Discussion at NAPCON-Patna

Building on the study findings, the panel discussion reflected how these outcomes translate into real-world practice. Dr. Agam Vora (MD, FCCP; Medical Director at Brahma Kumari's Global Hospital & Research Centre and Vora Clinic, Mumbai) emphasized that inhaled therapy remains central to COPD care, but acknowledged that patients who remain more symptomatic may need an early add-on, stating that “Dual bronchodilators are the mainstay, but whenever they are more symptomatic or breathless, a preparation like this (theophylline etophylline combination) could be the first add-on before you actually consider anything else.”

Supporting this approach, Dr. P. Sukumaran (MBBS, MD TB & Respiratory diseases- Emeritus Professor, Respiratory Medicine, Pushpagiri Medical College Hospital, Thiruvalla, Kerala) the added clinical benefit observed in routine practice, noting that “when a small dose of the combination of etofylline plus theophylline is added, patients actually do better than with inhaler alone and that certain groups, especially the chronic bronchitis type, may clearly require it”.

Dr. Sudhir Kumar (MBBS MD DM Pulmonology, PGI Chandigarh, leading Consultant Pulmonologist Patna) further refined this patient selection by pointing out that he would prefer adding it in patients with severe COPD, where maintaining good symptom control is particularly important. Reinforcing these practical considerations, Dr. S.K. Jindal (Former HOD Respiratory medicine- PGI Chandigarh, Director, Jindal Clinics, Chandigarh) noted that COPD patients are symptomatic throughout the day and especially at night. Preparation like the combination of etofylline plus theophylline would certainly help these patients at night.

Dr N. T. Awad (Head, Pulmonary Medicine, Sion Hospital, Mumbai), noted, “We use this combination of etofylline plus theophylline in acute exacerbation cases. Toxicity is very rare, which can be monitored”.

Expert Pulmonologists’ Insights from Panel Discussion at NAPCON-Jaipur

While presenting the interim findings of DRWE study at Jaipur session, Dr. Mohan Kumar (MD, DSc, DPPR, AB, Senior Consultant in Pulmonary, Critical Care & Sleep Medicine at OneCare Medical Center, Coimbatore), “We’re talking about a molecule that has been used for over 70 years and is still relevant today because it works well as an add-on therapy. It continues to be used because it is affordable, effective, and offers benefits like central and diaphragmatic action”.

Adding a clinical perspective, Dr. Pralhad Prabhudesai (MD, DNB, FCCP (USA), Consulting Chest Physician at Lilavati Hospital, Mumbai) stated, “The combination of etofylline plus theophylline definitely has a role in our clinical practice, and in my experience, it’s very safe for long term usage. Its anti-inflammatory properties potentiate action of inhalers.”

Further elaborating on the etophylline plus theophylline combination’s HDAC activity, Dr. Rajiv Garg (MD, Professor, King George's Medical University, Lucknow) explained, "HDAC, or histone deacetylase, improves corticosteroid sensitivity. In patients who are steroid-resistant, increasing HDAC activity can help enhance the response to corticosteroid therapy.”

Sharing insights from routine practice, Dr. Sandeep Nayar (MD, Principal Director and HOD – Chest and Respiratory Disease, BLK-Max Superspeciality Hospital, Delhi) added, “Once-daily oral theophylline really improves patient compliance and lung function. Patients comply better, and they themselves start feeling noticeably better.”

Along similar lines, Dr. Ajit Bhaskar (MD, DipNB, DTCD, Consultant, PVS Sunrise Hospital, Kozhikode) noted, “In real-world practice, many patients do well on oral bronchodilators—even at higher doses—and our tolerance levels may differ from global standards. It’s a good old, affordable drug, and after 35 years of using it, I still see patients benefiting from it.”

Dr S.K. Luhadia (MBBS, MD, Tuberculosis & Respiratory Medicine Consultant) highlighted, that " The choice of theray always depends on the clinical scenario and the patient's profile. If bronchodilator therapy is required, a combination of etophylline plus theophylline may be considered. "

Take Home Message

Overall, this NAPCON 2025 Patna and Jaipur session reiterated the value of large-scale Indian real-world evidence with theophylline plus etophylline in guiding respiratory practice. The study findings and expert discussion supported the combination of etofylline plus theophylline as a safe, effective, and practical first add-on option in selected obstructive airway disease patients, particularly those who remain symptomatic despite inhaled therapy or face inhaler-related barriers.

The session’s key message was clear: evidence-based respiratory care must also be patient-centric, adaptable, and grounded in real-world clinical realities.

Reference:

1. Live Streaming. (2025, November 15). Theophylline Etofylline Combination-NAPCON Nov 15 2025 [Video]. YouTube. https://www.youtube.com/live/6Ko83WWlqEc

2. Live Streaming. (2025, December 12). Theophylline Etofylline Combination-NAPCON Dec 12 2025 [Video]. YouTube. https://www.youtube.com/watch?v=D9uZWjyilN8

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