Formoterol
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Formoterol: Respiratory malformation
One-Sentence Summary
Formoterol is a long-acting beta2-agonist that relaxes airway smooth muscle. The TxGNN model predicts it may be relevant for respiratory malformation, but no clinical trials and no publications directly studying this condition were found, so the prediction rests on the model 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 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Formoterol belongs to the long-acting beta2-agonist class, which relaxes airway smooth muscle and widens the airways.
No credible mechanistic link to respiratory malformation was identified. Structural congenital malformations are not something a bronchodilator can be expected to correct. The literature retrieved concerns asthma and COPD rather than malformations, and the match appears to be driven by loose ontological proximity between respiratory conditions rather than a biological rationale. The prediction should therefore be treated as a weak, hypothesis-level signal.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
None of the publications retrieved directly studies respiratory malformation. They concern formoterol in other conditions (asthma, COPD) or unrelated topics, and are listed only for transparency.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 40840693 | 2026 | RCT (meta-analysis) | J Am Pharm Assoc | Budesonide/glycopyrrolate/formoterol compared with glycopyrrolate/formoterol in COPD |
| 35115339 | 2022 | RCT | Eur Respir J | Repeated-dose budesonide/formoterol vs salbutamol in stable 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 protected 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 (not related to formoterol use) |
| 35034195 | 2022 | Cohort | Eur J Appl Physiol | Compensatory responses to increased mechanical abnormalities in COPD during sleep |
| 37691104 | 2023 | Cohort | J Med Case Rep | Small airway disease in post-acute COVID-19 syndrome (single-patient follow-up) |
| 41686546 | 2026 | Case report | Medicine | Schizophyllum commune-associated allergic bronchopulmonary mycosis in a postoperative lung cancer patient |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 14419X | Foradile | Capsule containing powder for oral inhalation, formoterol fumarate dihydrate 12 micrograms (for use in Foradile Aerolizer) | Not stated in the data compiled for this report |
Safety Considerations
- Drug Interactions: 100 interacting drugs were recorded. Examples at moderate level include acarbose, famotidine, albiglutide, alogliptin, canagliflozin, dapagliflozin, empagliflozin, dulaglutide, chlorpropamide, cisapride, clarithromycin, dolasetron, ephedrine, diethylpropion and isometheptene. Corticosteroids (beclomethasone, betamethasone, budesonide, dexamethasone) are recorded at minor level.
Please refer to the TGA-approved Product Information (PI) for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high (0.9992), but there are no clinical trials, no publications directly studying respiratory malformation, and no plausible mechanistic link for a bronchodilator in structural congenital conditions. The evidence level is L5.
To proceed, the following is needed:
- A plausible mechanistic rationale linking beta2-agonism to the predicted condition
- Any direct preclinical or clinical study in respiratory malformation
- Mechanism of action data and the TGA Product Information safety sections (warnings and contraindications)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.