Salmeterol
| Evidence Level: L5 | Predicted Indications: 3 |
Table of Contents
Salmeterol: Respiratory malformation
One-Sentence Summary
Salmeterol is a long-acting beta2-adrenergic agonist (LABA) delivered by inhalation. The TxGNN model predicts it may be relevant to respiratory malformation, with a score of 0.9991. Evidence is very limited: 2 registered clinical trials and 8 publications were compiled, and none of them directly studies this condition.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Respiratory malformation |
| TxGNN Prediction Score | 0.9991 |
| 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 currently available in the data compiled for this report. Based on general pharmacology, salmeterol is a long-acting beta2-agonist that relaxes airway smooth muscle and can increase ciliary beat frequency.
The prediction is probably driven by an association with cystic fibrosis, primary ciliary dyskinesia or impaired ciliary function, rather than with structural disease. Improved ciliary beating is a symptomatic effect and does not treat congenital structural malformations of the airway or lung. No direct evidence supports using salmeterol in congenital respiratory malformation. The high model score should therefore be treated as a hypothesis only.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT00005110 | Not applicable | Suspended | Not reported | Six-month comparison of inhaled salmeterol with albuterol or placebo in cystic fibrosis. A different disease, and the study was not completed. |
| NCT01681979 | Not stated | Completed | 1 | Asthma treatment in pregnancy and adverse pregnancy outcomes. Not relevant to respiratory malformation. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 34902004 | 2022 | Randomised clinical trial | JAMA Pediatrics | Inhaled corticosteroids alone or with a LABA for reduced lung function in preterm-born children. Related to lung function, not malformation. |
| 15293609 | 2004 | Randomised crossover study | European Respiratory Journal | Salmeterol and the ventilatory response to exercise in COPD (23 patients). |
| 20528601 | 2010 | Review | Journal of Asthma | Budesonide/formoterol inhaler in persistent asthma. |
| 26229457 | 2015 | Review | Int J Chron Obstruct Pulmon Dis | Dual bronchodilation (indacaterol-glycopyrronium) in COPD. |
| 22608352 | 2012 | Laboratory study | Respiratory Medicine | Ciliary beating is depressed in nasal cilia from COPD patients. |
| 30021361 | 2018 | Laboratory study | Biomedicine & Pharmacotherapy | Thyme extract increases ciliary beating in COPD cell lines. |
| 37327273 | 2023 | Case report | Medicine | Pulmonary aspergillosis treated with omalizumab. |
| 20703071 | 2010 | Case report | Arerugi | Primary ciliary dyskinesia in a patient previously treated as asthma. |
None of these publications directly studies salmeterol in respiratory malformation.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 14328D | Serevent Accuhaler | Powder for oral inhalation in breath actuated device, 50 micrograms (as xinafoate) per dose, 60 doses | Not available in the data compiled for this report |
Safety Considerations
Please refer to the TGA-approved Product Information (PI) for safety information.
Drug Interactions (100 interactions were identified in the interaction database; main examples):
- Major: clarithromycin
- Moderate: epinephrine, famotidine, acarbose, canagliflozin, dapagliflozin, empagliflozin, alogliptin, dulaglutide, albiglutide, chlorpropamide, dolasetron, diethylpropion, isometheptene
- Minor: corticosteroids such as hydrocortisone, dexamethasone, budesonide, beclomethasone and triamcinolone
Interactions with antidiabetic agents are worth noting, as beta2-agonists can raise blood glucose.
Conclusion and Next Steps
Decision: Hold
Rationale: The TxGNN score is high (0.9991), but no trial or publication studies salmeterol in respiratory malformation. The only link is indirect, through ciliary function, and does not apply to structural defects. The evidence level is L5.
To proceed, the following is needed:
- Direct preclinical or clinical evidence in respiratory malformation
- Mechanism of action data and a clear rationale for how a symptomatic bronchodilator could apply to structural disease
- Review of the TGA-approved Product Information for safety, contraindications and warnings
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.