Terbutaline
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Terbutaline: Respiratory malformation
One-Sentence Summary
Terbutaline is a β2-adrenergic agonist bronchodilator marketed in Canada. The TxGNN model predicts it may be relevant to respiratory malformation, with a score of 0.9952. Support is weak: 1 registered clinical trial (a general pharmacokinetic study, not specific to this condition) and several publications that mostly address other conditions.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Respiratory malformation |
| TxGNN Prediction Score | 0.9952 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 1 of 1) |
| Number of DINs | 1 (marketed: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the data compiled for this report. Terbutaline belongs to the β2-adrenergic agonist class, which relaxes airway smooth muscle and relieves reversible bronchospasm.
Structural airway anomalies are often accompanied by bronchospasm or airway hyperreactivity, so a β2 agonist could ease those symptoms. It would not correct the malformation itself. The high score most likely reflects the model’s association with airway disease in general rather than disease-specific efficacy. Some of the retrieved literature concerns the differential diagnosis of airway stenosis in children, which is a diagnostic question and not a treatment indication.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT04278404 | N/A | Recruiting | 5000 | Broad pharmacokinetics and safety study of understudied drugs in children; not specific to respiratory malformation |
Literature Evidence
None of the publications below studies terbutaline in respiratory malformation itself.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 3281307 | 1988 | RCT | Thorax | Double-blind comparison of subcutaneous adrenaline and terbutaline in 20 patients with acute severe asthma |
| 1629507 | 1992 | RCT | J Allergy Clin Immunol | Budesonide vs terbutaline on airway inflammation in 14 adults with newly diagnosed asthma |
| 12061354 | 2002 | Cohort | Acta Paediatr | Spirometry and chest X-ray for diagnosing central airway stenosis in children, differentiated from asthma |
| 11813927 | 2001 | Case series | Cardiol Young | Oral terbutaline raised the heart rate in some fetuses with complete heart block |
| 1620986 | 1992 | Observational | Respiration | Inhaled terbutaline reversed abnormal respiratory impedance in chronic bronchitis |
| 8327281 | 1993 | Methodological | Pediatr Pulmonol | Flow-volume curve analysis in intubated premature infants after terbutaline |
| 19793774 | 2009 | Hypothesis/Review | Toxicol Ind Health | Hypothesis on terbutaline, mould exposure and autism-related brain and lung impairment |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 00786616 | BRICANYL TURBUHALER | Not specified | Not specified |
Safety Considerations
- Conditions listed as contraindications in reference data (not label text): hypertension, epilepsy, hyperglycemia, diabetes mellitus and diabetic ketoacidosis, potassium deficiency, hyperthyroidism and thyrotoxicosis, heart conduction disease, sudden cardiac arrest, myocardial ischemia and coronary artery disease, respiratory failure, pulmonary edema, and placental abruption.
- Drug Interactions: 100 interactions were identified. Moderate-level examples include epinephrine, famotidine, clarithromycin, and several antidiabetic drugs (acarbose, alogliptin, pioglitazone, canagliflozin, chlorpropamide, albiglutide). Minor-level examples include corticosteroids such as hydrocortisone, dexamethasone, budesonide, and beclomethasone.
Please also refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by a model score. No trial or publication directly studies terbutaline in respiratory malformation, so the evidence level is L5. A β2 agonist could at most relieve accompanying bronchospasm and would not treat the malformation.
To proceed, the following is needed:
- Studies that directly evaluate terbutaline in respiratory malformation, or a clearly defined symptomatic target such as airway hyperreactivity in affected patients
- Mechanism-of-action data and the Health Canada package insert warnings and contraindications
- A paediatric safety review, given the cardiovascular and metabolic cautions above
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.