Terbutaline
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Terbutaline: Respiratory malformation
One-Sentence Summary
Terbutaline is a short-acting beta-2 adrenergic agonist (bronchodilator). The TxGNN model predicts it may be relevant to respiratory malformation, but the evidence is thin: 1 registered clinical trial (a broad paediatric pharmacokinetic study, not specific to this condition) and 13 publications, none of which directly study respiratory malformation as a treatment target.
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 |
| 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. Terbutaline is generally understood to be a beta-2 adrenergic agonist, which relaxes airway smooth muscle and produces bronchodilation.
This mechanism could, in principle, relieve secondary airway obstruction or airway hyperreactivity in a patient who has a respiratory malformation. It would not correct the structural abnormality itself. The supporting literature is mostly about asthma, differential diagnosis of airway stenosis, or unrelated topics, so the link between terbutaline and this prediction is indirect and should be read as a hypothesis only.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT04278404 | N/A | Recruiting | 5000 | Broad observational study of the pharmacokinetics and safety of understudied drugs given to children; not specific to respiratory malformation |
Literature Evidence
| 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 | Clinical study (randomised) | J Allergy Clin Immunol | Inhaled budesonide vs terbutaline on airway inflammation in 14 adults with newly diagnosed asthma |
| 12061354 | 2002 | Cohort | Acta Paediatr | Central airway stenosis (including vascular ring anomalies) in 14 school-aged children, and its differentiation from asthma |
| 11813927 | 2001 | Case series | Cardiol Young | Oral terbutaline in fetal complete heart block; heart rate initially rose in 6 of 7 fetuses |
| 1620986 | 1992 | Clinical study | Respiration | Inhaled terbutaline reversed abnormal respiratory impedance in chronic bronchitis |
| 19254906 | 2009 | Clinical study | Arch Dis Child | Budesonide improved airway conductance in infants with respiratory symptoms |
| 42303000 | 2026 | Cohort | Respir Med | Multidimensional evaluation of long-term treatment in infants with post-infectious bronchiolitis obliterans |
| 8327281 | 1993 | Methodology | Pediatr Pulmonol | Flow-volume curve analysis in intubated premature infants before and after terbutaline |
| 9628312 | 1998 | Case report | Acta Paediatr | Follow-up of a patient with multiple anomalies and hypokalaemic paralysis, with partial symptom relief from terbutaline |
| 2876923 | 1986 | Comparative study | J Int Med Res | Tulobuterol vs terbutaline in childhood asthma |
None of these publications tests terbutaline in respiratory malformation.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 1034K | Bricanyl | Injection containing terbutaline sulfate 500 micrograms in 1 mL | Not stated in the data compiled for this report |
At least one valid single-ingredient licence is on record (1 valid, 0 cancelled).
Safety Considerations
Label-based warnings and contraindications are not available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for safety information.
Drug interactions: 100 interactions were recorded. Examples at Moderate level include acarbose, epinephrine, famotidine, pioglitazone, canagliflozin, clarithromycin, alogliptin, albiglutide and chlorpropamide. Corticosteroids such as hydrocortisone, dexamethasone, budesonide and beclomethasone are recorded at Minor level.
Conditions flagged for caution (not label text): hypertension, epilepsy, hyperglycaemia, diabetes mellitus, diabetic ketoacidosis, hypokalaemia (potassium deficiency), hyperthyroidism, cardiac arrest, heart conduction disease, respiratory failure, pulmonary oedema, myocardial ischaemia and coronary artery disease, and placental abruption.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high, but no study examines terbutaline in respiratory malformation, and the only registered trial is a general paediatric pharmacokinetic study. Beta-2 agonism could at most ease secondary airway symptoms, not treat the malformation. The evidence level is therefore L5.
To proceed, the following is needed:
- Mechanism of action data and a clearer rationale for how bronchodilation would benefit this condition
- Clinical or observational studies that directly examine terbutaline in respiratory malformation
- Review of the TGA Product Information for warnings and contraindications, especially for the injectable form in paediatric patients
- Confirmation of the approved indication text for the Australian licence
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.