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Pulmicort Respules (Budesonide) - Summary

 
 



SUMMARY

Pulmicort Respules®
(budesonide inhalation suspension)
0.25 mg and 0.5 mg

Budesonide, the active component of PULMICORT RESPULES®, is a corticosteroid.

PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.

PULMICORT RESPULES is NOT indicated for the relief of acute bronchospasm.


See all Pulmicort Respules indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Pulmicort Respules (Budesonide)

EC's CHMP Recommends Combo Inhalers for COPD, Asthma
Source: Medscape Medical News Headlines [2014.09.26]
The committee has endorsed the combination of aclidinium bromide/formoterol fumarate for COPD, and a budesonide/formoterol combination for COPD and asthma.
International Approvals

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Published Studies Related to Pulmicort Respules (Budesonide)

Safety and Tolerability of High-Dose Budesonide/Formoterol via Turbuhaler(R) in Japanese Patients with Asthma: A Randomized, Double-Blind, Crossover, Active Comparator-Controlled, Phase III Study. [2012.01.01]
Background: The use of budesonide/formoterol as both maintenance and reliever therapy in asthma is recommended in many countries; however, there are limited data available for the Asian patient population. Objective: This study aimed to evaluate the short-term safety and tolerability of a fixed high-dose combination of the inhaled corticosteroid budesonide and the long-acting beta(2)-adrenoceptor agonist formoterol with that of the beta(2)-agonist terbutaline for acute symptom relief in Japanese adults with persistent asthma who were already receiving a combination of budesonide/formoterol maintenance therapy...

Abatacept for Crohn's disease and ulcerative colitis. [2012]
modulator, in Crohn's disease (CD) and ulcerative colitis (UC) is unknown... CONCLUSIONS: The studies showed that abatacept is not efficacious for the

AZD9668, a neutrophil elastase inhibitor, plus ongoing budesonide/formoterol in patients with COPD. [2012]
well tolerated at doses of 60 mg bid during Phase I/IIa development... CONCLUSIONS: Three months' treatment with AZD9668 did not improve lung function,

Budesonide/Formoterol Pressurized Metered-Dose Inhaler versus Budesonide: A Randomized Controlled Trial in Black Patients with Asthma. [2011.12.01]
Objective.In this population of black asthma patients, BUD/FM pMDI resulted in greater improvements in pulmonary function and asthma control versus BUD DPI, with similar safety profiles.

A comparison of budesonide/formoterol maintenance and reliever therapy versus conventional best practice in asthma management in Spain. [2011.10]
OBJECTIVE: To study the effectiveness and safety in a real-life setting of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy(R) (Symbicort SMART(R)), a simplified management approach with one inhaler, compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma... CONCLUSIONS: A simplified regimen using budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and lower drug costs.

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Clinical Trials Related to Pulmicort Respules (Budesonide)

Adults With Moderate to Severe Asthma [Completed]
A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

Assess the Efficacy and Safety of Rhinocort Aqua [Completed]
The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.

New Version Pulmicort Turbuhaler USA Children [Completed]
A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.

New Version Pulmicort Turbuhaler USA Adults [Completed]
A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have asthma and are currently being treated with inhaled steroids. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.

Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children [Completed]
A one year study comparing the safety and effectiveness of Pulmicort (0. 5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.

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Page last updated: 2014-09-26

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