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 bronchial smooth muscle and is marketed in Canada. The TxGNN model predicts it may be relevant to respiratory malformation, but no clinical trials and no publications that directly study this condition support the prediction, so it rests on the model score alone.
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 |
| Canada Market Status | Marketed (marketed DINs: 8 of 8) |
| Number of DINs | 8 (marketed: 8) |
| 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 generally known as a long-acting beta2-adrenergic agonist, which relaxes bronchial smooth muscle and widens the airways.
That mechanism is symptomatic. It offers no plausible route for correcting structural congenital malformations of the respiratory tract. The high score of 0.9992 most likely reflects the model linking the drug to the broader category of respiratory disease rather than a real biological connection to this condition.
The publications retrieved for this prediction cover asthma, COPD, Down syndrome cognition and long COVID sequelae. None addresses respiratory malformation, so the literature match appears to be driven by keywords.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
None of the publications below studies respiratory malformation directly. They are listed to show what was retrieved.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 40840693 | 2026 | Systematic review / meta-analysis | J Am Pharm Assoc | Compares budesonide/glycopyrrolate/formoterol with glycopyrrolate/formoterol for COPD safety and efficacy |
| 35115339 | 2022 | RCT | Eur Respir J | Repeated-dose budesonide/formoterol vs salbutamol in adult asthma: bronchodilator, systemic and cardiovascular effects |
| 22541245 | 2012 | RCT | J Allergy Clin Immunol | Long-term safety of budesonide/formoterol pMDI in African American patients with asthma |
| 14738234 | 2004 | RCT | Eur Respir J | Formoterol protects against platelet-activating factor-induced effects in asthma |
| 20528601 | 2010 | Review | J Asthma | Review of budesonide/formoterol pMDI in persistent asthma |
| 24842803 | 2014 | Review | Prog Neuropsychopharmacol Biol Psychiatry | Neurotransmitter-based strategies for cognitive dysfunction in Down syndrome |
| 35034195 | 2022 | Cohort | Eur J Appl Physiol | Compensatory responses to increased mechanical loading in COPD during sleep |
| 37691104 | 2023 | Case report | J Med Case Rep | Small airway disease in a long COVID patient followed for three years |
| 41686546 | 2026 | Case report | Medicine | Schizophyllum commune-associated allergic bronchopulmonary mycosis after lung cancer surgery |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02237224 | OXEZE TURBUHALER | Not listed | Not listed |
| 02237225 | OXEZE TURBUHALER | Not listed | Not listed |
| 02245386 | SYMBICORT 200 TURBUHALER | Not listed | Not listed |
| 02245385 | SYMBICORT 100 TURBUHALER | Not listed | Not listed |
| 02361760 | ZENHALE | Not listed | Not listed |
All 8 licences on record are valid; the five above are the first five listed.
Safety Considerations
- Drug Interactions: 100 interactions were found in the interaction screening. Moderate-level examples include acarbose, famotidine, clarithromycin, cisapride, dolasetron, ephedrine, and several diabetes drugs (alogliptin, canagliflozin, dapagliflozin, empagliflozin, chlorpropamide, albiglutide, dulaglutide). Minor-level examples include the corticosteroids budesonide, beclomethasone, betamethasone and dexamethasone.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a model score. There are no clinical trials, no publications on respiratory malformation, and no plausible mechanism by which a bronchodilator would correct a structural congenital defect.
To proceed, the following is needed:
- Mechanism-of-action data for formoterol
- Package insert warnings and contraindications from Health Canada
- Any direct preclinical or clinical evidence in respiratory malformation
- A clear biological rationale linking beta2-adrenergic agonism to this condition
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.