Salmeterol
| Evidence Level: L5 | Predicted Indications: 3 |
Table of Contents
Salmeterol: Respiratory malformation
One-Sentence Summary
Salmeterol is a long-acting beta2-adrenergic agonist bronchodilator used in airway disease. The TxGNN model predicts it may be effective for respiratory malformation (score 0.9991), but the evidence is weak: 2 registered clinical trials and 8 publications were retrieved, and none 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 |
| 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 is not available in the data compiled for this report. Based on general pharmacology, salmeterol is a long-acting beta2-agonist. It relaxes airway smooth muscle and may increase ciliary beat frequency and mucociliary clearance.
The link to the predicted condition is indirect. Respiratory malformation is a structural category, and a beta2-agonist is not expected to correct a structural defect. At most, salmeterol might ease symptoms of related airway problems such as impaired mucus clearance. The retrieved evidence concerns COPD, asthma, cystic fibrosis and ciliary function, not malformation itself. The prediction is therefore a computational signal without direct clinical support.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00005110 | Not applicable | Suspended | Not reported | Long-term salmeterol vs albuterol or placebo, inhaled twice daily for 6 months, in cystic fibrosis. A related airway condition, not a malformation; no results available. |
| NCT01681979 | Not applicable | Completed | 1 | Asthma treatment in pregnancy and adverse pregnancy outcomes. Does not address respiratory malformation as a treatment target. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 34902004 | 2022 | Randomized trial (classified as systematic review) | JAMA Pediatrics | Inhaled corticosteroids alone or with long-acting beta2-agonists for reduced lung function in preterm-born children. |
| 20528601 | 2010 | Review | J Asthma | Budesonide/formoterol inhaler in persistent asthma; a different drug combination. |
| 26229457 | 2015 | Review | Int J COPD | Dual bronchodilation with indacaterol-glycopyrronium in COPD; a different drug. |
| 15293609 | 2004 | Clinical physiology study | Eur Respir J | Salmeterol reduced lung hyperinflation and improved exercise ventilatory response in COPD. |
| 22608352 | 2012 | Laboratory study | Respir Med | Nasal ciliary beating is depressed in COPD. |
| 30021361 | 2018 | Laboratory study | Biomed Pharmacother | Thyme extract increased mucociliary beat frequency in COPD patient cells. |
| 20703071 | 2010 | Case report | Arerugi | Primary ciliary dyskinesia in a patient previously treated as asthma. |
| 37327273 | 2023 | Case report | Medicine | Pulmonary aspergillosis treated with omalizumab. |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 38723 | Combitide 50mcg/100mcg Octacap (Sun Pharmaceutical) | Box of 30 capsules | Not listed |
| 4192 | Airtec SF 500 Instacap (Glenmark) | Bottle of 30 instacaps | Not listed |
| 183159 | Quikhale SF 50 mcg/500 mcg Capsule (Intas) | Strip of 30 capsules | Not listed |
| 200302 | Seroflo 125 Synchrobreathe (Cipla) | Packet of 120 MDI inhaler | Not listed |
| 72466 | Esiflo 250 Transhaler (Lupin) | Packet of 120 MDI transhaler | Not listed |
The data list 20 valid licences, and the records may be partial.
Safety Considerations
Package insert warnings and contraindications are not available in the data compiled for this report; please refer to the package insert.
Drug Interactions: 598 interactions were recorded. Examples include:
- Major: clarithromycin
- Moderate: epinephrine, isometheptene, famotidine, acarbose, canagliflozin, dapagliflozin, empagliflozin, dolasetron
- Minor: hydrocortisone, dexamethasone, budesonide, beclomethasone dipropionate
Conclusion and Next Steps
Decision: Hold
Rationale: No retrieved trial or publication directly studies respiratory malformation, so evidence is limited to a model prediction (L5). A beta2-agonist is also not expected to correct a structural defect.
To proceed, the following is needed:
- A clear biological rationale for how salmeterol would act on the specific malformation
- Direct clinical or preclinical studies in this condition
- Mechanism of action data
- Package insert warnings and contraindications for a safety review
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.