In short
Terbutaline sulfate is a bronchodilator medicine that relaxes and opens the airways, making it easier to breathe. It is an authorised medicine in Spain, sold as Terbasmin Turbuhaler, and is classified as a beta agonist (ATC code R03AC03). In one Phase 3 clinical trial with 410 participants, it is used as an auxiliary medicine to manage asthma symptoms in people with allergic rhinoconjunctivitis caused by house dust mites.
Key points
- Terbutaline sulfate is a bronchodilator classified as a beta agonist (ATC code R03AC03).
- It appears in one Phase 3 clinical trial as an auxiliary medicine, not as the main treatment being tested.
- The trial includes 410 participants with allergic rhinoconjunctivitis with or without controlled asthma.
- Terbutaline is given as an inhalation powder in the trial, under the name Terbasmin Turbuhaler.
- The trial compares two concentrations of house dust mite immunotherapy against placebo.
How does terbutaline sulfate work?
Terbutaline works by relaxing and opening the airways in the lungs, which makes it easier to breathe. It does this by acting on beta receptors in the airways, which are part of the body's system for controlling how wide or narrow the air passages are. This action helps relieve wheezing, shortness of breath, and chest tightness. The Devon Formulary lists terbutaline under adrenoceptor agonists, which are medicines that stimulate these beta receptors.
Which conditions is terbutaline sulfate used or studied for?
- Asthma — Terbutaline is used to prevent and treat wheezing, shortness of breath, and chest tightness caused by asthma.
- Chronic bronchitis — It is also used to manage breathing difficulties in people with chronic bronchitis.
- Emphysema — Terbutaline helps relieve symptoms in people with emphysema, a long-term lung condition.
- Allergic rhinoconjunctivitis with or without controlled asthma — In the Phase 3 trial, terbutaline is used as an auxiliary medicine to manage asthma symptoms while the main treatment being tested is house dust mite immunotherapy.
How is terbutaline sulfate given?
In the clinical trial, terbutaline sulfate is provided as an inhalation powder, taken by inhalation using the Terbasmin Turbuhaler device. The product information in the registry lists the route of administration as inhalation. Beyond the trial, terbutaline sulfate is available in several forms. The NHS dm+d browser lists terbutaline tablets, oral solutions, nebuliser liquids, injection solutions, and dry powder inhalers. MedlinePlus describes terbutaline as a tablet taken by mouth, usually three times a day.
What do the clinical trials show?
Terbutaline sulfate appears in one clinical trial in the EU Clinical Trials Information System. The trial is a Phase 3 study with 410 participants who have moderate to severe persistent allergic rhinoconjunctivitis caused by house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), with or without controlled asthma. In this trial, terbutaline is not the main treatment being investigated. It is listed as an auxiliary medicine, meaning it is used to support participants by managing asthma symptoms while the study evaluates two concentrations of subcutaneous immunotherapy (SCIT) against placebo.
The main treatment being tested is a mixture of allergenic extracts from two house dust mite species. The primary outcome measures the change in a combined symptom and medication score (cSMS) from the start of the trial to after 12 doses of immunotherapy have been given. Participants record their symptoms daily in an electronic diary on a mobile device. The trial is currently authorised, meaning it has received approval to proceed.
What side effects are known?
MedlinePlus carries an important warning that terbutaline should not be used to stop or prevent premature labour in pregnant women, especially outside a hospital. Serious side effects, including death, have occurred in pregnant women who took terbutaline for this purpose, and serious side effects have also been reported in newborns whose mothers took it to stop or prevent labour. The sources provided do not list other specific side effects of terbutaline sulfate.