PULMICORT SUMMARY
PULMICORT TURBUHALER 200 mcg
(budesonide inhalation powder)
For Oral Inhalation Only.
Budesonide, the active component of PULMICORT TURBUHALER 200 mcg, 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 TURBUHALER 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 TURBUHALER is NOT indicated for the relief of acute bronchospasm.
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PULMICORT NEWS HIGHLIGHTS
Published Studies Related to Pulmicort (Budesonide Inhalation)
Budesonide for maintenance of remission in Crohn's disease. [2009.01.21]
CONCLUSIONS: Budesonide is not more effective than placebo or weaning prednisolone for maintenance of remission in Crohn's disease. Some modest benefits are noted in patients receiving budesonide compared with placebo in terms of lower CDAI scores and longer time to relapse of disease. However, these benefits are offset by higher treatment-related adverse event rates and more frequent adrenocorticoid suppression in patients receiving budesonide. Therefore, budesonide is not recommended for maintenance of remission in Crohn's disease.
Pharmacokinetics of a novel submicron budesonide dispersion for nebulized delivery in asthma. [2009.01.05]
The objective of this study was to evaluate the safety and pharmacokinetics of unit dose budesonide (UDB), an aqueous dispersion of submicron-sized budesonide particles, and a commercially available budesonide suspension formulation. This was a randomized, double-blind, active-controlled, 4-period, 4-way crossover trial in 16 healthy, adult volunteers...
Long-term budesonide treatment of collagenous colitis: a randomised, double-blind, placebo-controlled trial. [2009.01]
OBJECTIVE: To evaluate the efficacy and safety of long-term budesonide therapy for the maintenance of clinical remission in patients with collagenous colitis... CONCLUSIONS: Long-term maintenance therapy with oral budesonide is efficacious and well tolerated for preventing relapse in patients with collagenous colitis. The risk of relapse after 24 weeks' maintenance treatment is similar to that observed after 6 weeks' induction therapy.
Presystemic elimination of budesonide in man when administered locally at different levels in the gut, with and without local inhibition by ketoconazole. [2008.11.15]
The CYP3A4 substrate budesonide was used to investigate gut wall first-pass metabolism in jejunum, ileum and colon of eight healthy men. Three milligram budesonide in solution was installed at each location by intubation, with or without immediate prior local administration of 16mg ketoconazole...
Patient-reported outcomes in adults with moderate to severe asthma after use of budesonide and formoterol administered via 1 pressurized metered-dose inhaler. [2008.11]
BACKGROUND: Patient-reported outcomes (PROs) are important for evaluating asthma therapy. OBJECTIVE: To evaluate PROs in adults with moderate to severe persistent asthma receiving budesonide and formoterol administered via 1 pressurized metered-dose inhaler (pMDI)... CONCLUSION: Significantly greater improvements in health-related quality of life and asthma control and greater treatment satisfaction were observed with budesonide/formoterol pMDI vs placebo.
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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