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Terbutaline (Terbutaline Sulfate) - Summary

 



TERBUTALINE SUMMARY

Terbutaline sulfate USP is a beta-adrenergic agonist bronchodilator available as tablets of 2.5 mg (2.05 mg of the free base) and 5 mg (4.1 mg of the free base) for oral administration.

Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.


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NEWS HIGHLIGHTS

Published Studies Related to Terbutaline

A randomized, controlled trial of nebulized terbutaline for the first acute bronchiolitis in infants less than 12-months-old. [2009.03]
BACKGROUND: Despite the common clinical practice, the available evidence on the efficacy of bronchodilators therapy for bronchiolitis is conflicting. The aim of this study is to evaluate the efficacy of nebulized terbutaline in bronchiolitis as measured by improvement in clinical score, oxygen saturation or reduction in duration of hospitalization... CONCLUSION: Nebulized terbutaline therapy does not appear effective in treating moderately ill infants with the first acute bronchiolitis.

Terbutaline in myasthenia gravis: A pilot study. [2009.02.15]
The objective of this study was to assess the short-term efficacy and safety of terbutaline, a beta2-adrenergic agonist, in patients with myasthenia gravis (MG) in a randomized, double-blind, placebo-controlled, crossover study. The primary endpoint for efficacy was a reduction of at least 3 points in the quantitative MG score (QMGS)...

Oral nifepidine versus subcutaneous terbutaline tocolysis for external cephalic version: a double-blind randomised trial. [2009.01]
OBJECTIVE: To evaluate oral nifedipine versus subcutaneous terbutaline tocolysis for external cephalic version (ECV). DESIGN: A double-blind randomised trial. SETTING: A university hospital in Malaysia. POPULATION: Non-labouring women with a term singleton fetus in breech presentation or transverse lie suitable for elective ECV... CONCLUSIONS: Bolus subcutaneous terbutaline tocolysis for ECV compared with oral nifedipine resulted in less caesarean deliveries. ECV success rate was not significantly higher. Larger studies are indicated.

Terbutaline and the prevention of nocturnal hypoglycemia in type 1 diabetes. [2008.12]
CONCLUSIONS: Terbutaline may be shown to be effective and safe in the prevention of nocturnal hypoglycemia in type 1 diabetes in a suitably powered randomized controlled trial.

Nifedipine versus terbutaline for tocolysis in external cephalic version. [2008.09]
OBJECTIVE: To study the efficacy of nifedipine compared with terbutaline as a tocolytic agent in external cephalic version (ECV)... CONCLUSION: Nifedipine can be used as an alternative for tocolysis in ECV when there are maternal contraindications to beta-sympathomimetics.

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Clinical Trials Related to Terbutaline

Terbutaline Concentrations in Blood and Urine [Not yet recruiting]
The purpose of this study is to assess the blood and urine concentrations of terbutaline and to evaluate the difference between inhaled and oral terbutaline in order to distinguish treatment with terbutaline from doping with terbutaline in a doping control.

Comparing Symbicort As-Needed or Bricanyl As-Needed or Pulmicort Once Daily + Bricanyl As-Needed in Asthma Patients [Not yet recruiting]
1. The primary objective of this study is:

- To evaluate the magnitude of the protective effect of the combination of

budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma

2. The secondary objectives of this study are:

- To evaluate the magnitude of the protective effect of the combination of

budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma

- To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and

regular use of budesonide + terbutaline as-needed as terms of adverse event

Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma [Recruiting]
Study No. 001 about Budesonide/Formoterol use in ASthMA sponsored by Agenzia Italiana del FArmaco (Italian Drug Agency) (AIFA-ASMA-BF-001) The aim of the study is to verify whether asthma not controlled by low doses inhaled corticosteroids, thus in need for step up therapy, can be equally controlled by guidelines recommended regular bid treatment with long acting beta agonist/inhaled corticosteroid (ICS/LABA) combination or the symptom driven use of an ICS/LABA combination in the absence of maintenance therapy. The study is designed to be able to evaluate the non inferiority of regular placebo plus prn inhaled budesonide/formoterol (experimental treatment) versus regular, twice daily 160/4. 5 mcg inhaled budesonide/formoterol combination plus prn inhaled terbutaline (guidelines recommended treatment).

Study to Investigate the Efficacy of Symbicort SMART. [Recruiting]
The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4. 5μg, one inhalation bid plus as needed) with Symbicort Turbuhaler 160/4. 5μg, one inhalation bid plus terbutaline Turbuhaler 0. 4 mg as needed, as asthma therapy

Effects of Advair® in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation [Not yet recruiting]
Short course of steroids in COPD exacerbation improves FEV1 and decreases the relapse rate. However, some concerns remain about using systemic steroids for all patients with acute exacerbation. Their short-term advantages may be outweighed by the occurrence of adverse side effects such as hyperglycemia, which is difficult to manage on an outpatient basis. In this context, the possibility of treating patients with COPD exacerbation with inhaled steroids having less systemic adverse effects is interesting. The objectives are to compare relapse rate, lung function, the severity of dyspnea and, systemic and sputum inflammatory markers in outpatients with acute COPD exacerbations treated with fluticasone/salmeterol (Advair®) or oral prednisone for 10 days. The hypothesis is that Advair® is as effective as prednisone in treatment of outpatients with COPD exacerbation. The primary endpoint is to determine if the relapse rate at one month is equivalent for both treatments. The secondary endpoints are to compare lung function and dyspnea score and, systemic and sputum inflammatory markers modulation after 10 days of both treatments. We will recruit 30 outpatients in each group from our COPD clinic. Patients will receive prednisone (40mg/day) with placebo diskus or Advair® 50/500ug 2 inhalations bid (twice the regular dose) with placebo pills for 10 days. All patients will receive antibiotics and short-acting bronchodilators as needed. We expect to demonstrate that the improvement of lung function, dyspnea, inflammatory markers and relapse rate are equivalent in both treatments suggesting that Advair® could be a good alternative to prednisone for patients with steroid-induced hyperglycemia.

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Page last updated: 2009-10-20

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