Formoterol
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Formoterol: Respiratory malformation
One-Sentence Summary
Formoterol is a long-acting beta2-adrenergic agonist that relaxes airway smooth muscle and is marketed in India as inhaled and capsule products. The TxGNN model predicts it may be relevant to respiratory malformation, but no clinical trials and no publications directly studying this condition were found. The prediction rests on model output alone and is not supported by a plausible mechanism.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Respiratory malformation |
| TxGNN Prediction Score | 0.9992 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the data compiled for this report. Formoterol is known as a long-acting beta2-adrenergic agonist, which causes bronchodilation by relaxing airway smooth muscle.
Respiratory malformation is a structural, developmental defect of the airways or lungs. Bronchodilation could at most ease secondary airflow symptoms; it cannot correct or treat the malformation itself. No plausible mechanistic link is supported.
The high score appears to reflect the drug’s closeness to respiratory disease in the model’s network rather than a true therapeutic relationship. The prediction should be treated as a weak hypothesis only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
None of the retrieved publications directly studies respiratory malformation. They concern COPD, asthma and other conditions, and are listed only as background on formoterol in airway disease.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 35115339 | 2022 | RCT (crossover) | Eur Respir J | Repeated-dose budesonide/formoterol compared with salbutamol in stable adult asthma (bronchodilator, systemic and cardiovascular effects) |
| 22541245 | 2012 | RCT | J Allergy Clin Immunol | Long-term safety and asthma control of budesonide/formoterol pMDI in African American patients |
| 40840693 | 2026 | Systematic review / meta-analysis | J Am Pharm Assoc | Safety and efficacy of budesonide/glycopyrrolate/formoterol versus glycopyrrolate/formoterol in COPD |
| 20528601 | 2010 | Review | J Asthma | Budesonide/formoterol pMDI in persistent asthma |
| 14738234 | 2004 | Mechanistic clinical study | Eur Respir J | Formoterol protects against platelet-activating factor-induced effects in asthma |
| 35034195 | 2022 | Physiological study | Eur J Appl Physiol | Compensatory responses to increased mechanical abnormalities in COPD during sleep |
| 37691104 | 2023 | Case report | J Med Case Rep | Small airway disease in post-acute COVID-19 syndrome |
India Market Information
At least 20 valid single-ingredient licences were found, and the list may be partial. A selection of five:
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| Registration No. 176746 | Pulmofor B 200 Inhaler | Bottle of 120 MDI inhaler | AXA Parenterals Ltd |
| Registration No. 3183 | Airwin-BF 200 Capsule | Bottle of 30 capsules | Ultimate Healthcare |
| Registration No. 199689 | Symbicort 160mcg/4.5mcg Turbuhaler | Packet of 60 MDI inhaler | AstraZeneca |
| Registration No. 61813 | Duova Rotacap | Packet of 20 rotacaps | Cipla Ltd |
| Registration No. 84129 | Formoflo 250 Transhaler | Packet of 120 MDI Transhaler | Lupin Ltd |
Safety Considerations
- Drug Interactions: 462 interactions are recorded. Examples at moderate level include acarbose, famotidine, clarithromycin, cisapride, dolasetron, ephedrine, isometheptene, diethylpropion, and several antidiabetic agents (alogliptin, canagliflozin, dapagliflozin, empagliflozin, albiglutide, dulaglutide, chlorpropamide). Minor interactions include corticosteroids such as beclomethasone, betamethasone, budesonide and dexamethasone.
Please refer to the package insert for warnings and contraindications; this information was not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by a model score. No clinical trial or publication studies respiratory malformation, and bronchodilation cannot plausibly treat a structural developmental defect.
To proceed, the following is needed:
- Mechanism-of-action data and a credible biological rationale linking beta2-agonism to the target condition
- Package insert warnings and contraindications
- Any direct preclinical or clinical study in respiratory malformation, or a clearly defined symptom-relief use case with a defined patient group
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.