Pulmicort (Budesonide Inhalation) - Summary

PULMICORT SUMMARY

PULMICORT FLEXHALER™ 180 mcg
(budesonide inhalation powder, 180 mcg)

PULMICORT FLEXHALER™ 90 mcg
(budesonide inhalation powder, 90 mcg)
For Oral Inhalation Only

Budesonide, the active component of PULMICORT FLEXHALER is a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde.

PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.

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

See all Pulmicort indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Pulmicort (Budesonide Inhalation)

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 (Budesonide Inhalation)

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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Reports of Suspected Pulmicort (Budesonide Inhalation) Side Effects

Asthma (88),  Dyspnoea (87),  OFF Label USE (83),  Drug Dose Omission (70),  Malaise (62),  Cough (33),  Chronic Obstructive Pulmonary Disease (29),  Drug Ineffective (24),  Pneumonia (23),  Dysphonia (18), more >>