Skip to content
Home - Clinical trials - Pulmicort™ (budesonide)    
Pulmicort™ (budesonide) Clinical Trial report summaries

Pulmicort™ (budesonide) is an inhaled anti-inflammatory glucocorticosteroid, primarily for once- or twice-daily maintenance treatment of asthma. Pulmicort™ is also indicated for the treatment of chronic obstructive pulmonary disease in some countries.

The following inhaled formulations are available: PulmicortTurbuhaler, PulmicortpMDI, and Pulmicort suspension (Pulmicort Respules) for nebulisation. 
  

Please consult the prescribing information for the country concerned for guidance on the approved use of Pulmicort™ (budesonide).

Study Number Completed Clinical Trial Report Summaries

D5252C00001

A pharmacokinetic comparison of orally inhaled budesonidedelivered via SkyePharma HFA metered dose inhaler and marketed CFC metered dose inhaler (Pulmicort® , AstraZeneca) in healthy male and female volunteers.
D5252C00002A Randomized, Double-Blind, Active-Controlled, Parallel Group, Stratified, Multicenter, 12-Week Study to Evaluate the Safety and Efficacy after Multiple Dosing of Investigational Budesonide HFA Metered Dose Inhalers Compared with Conventional Budesonide CFC Metered Dose Inhalers (Pulmicort®) in Patients with Asthma.

D5252C00003

A Randomized, Double Blind, Parallel Group, Stratified, Multicenter, 12-Week Safety and Efficacy Study of an Investigational Budesonide HFA Metered Dose Inhaler and a Conventional Budesonide CFC Metered Dose Inhaler (Pulmicort®) in Pediatric Patients with Asthma.

D5252C00004

A Randomised, Open-Label, Active-Controlled, Parallel Group, Single-Centre, 4-Week Study to Evaluate the Safety of High Dose Budesonide after Multiple Dosing with Investigational HFA Metered Dose Inhaler and Conventional CFC Metered Dose Inhaler (Pulmicort®) in Healthy Subjects.
D5252C00006An open-label, randomised crossover study of budesonide pharmacokinetics and the effect of budesonide on 24-hour plasma/urine cortisol concentrations when administered via HFA pMDI, CFC pMDI and Turbuhaler® for 6.5 days in healthy volunteers.
DX-RES-2103An evaluation of the effectiveness of Pulmicort Respules® (budesonide inhalation suspension) versus Singulairâ (montelukast sodium) in children 2 to 8 years old with asthma requiring controller therapy.

SD-004-0111

START - Inhaled Steroid Treatment As Regular Therapy in early asthma

A study of the effect of early intervention with long-term inhaledbudesonide (Pulmicort Turbuhaler ®) in newly diagnosed asthma. 

SD-004-0210

Efficacy and safety of Pulmicort (budesonide) via Turbuhaler® , new version, in corticosteroid-using adult asthmatic patients.

SD-004-0216

Oxis Turbuhaler ® (formoterol), Accolate ® (zafirlukast) or placebo as add on treatment to Pulmicort Turbuhaler ® (budesonide) in asthmatic patients on inhaled steroids.

SD-004-0299 

Prevention of asthma in infants/young children - PAC.

SD-004-0377

Once daily administration of 200 µg budesonide Turbuhaler® and 200 µg fluticasone propionate via Diskus® inhaler in stable asthmatics.

SD-004-0378

The effects of budesonide (Pulmicort Turbuhaler® 400 µg once daily or montelukast sodium (Singulair® 10 mg once daily on inflammation in mild steroid-free asthmatics following Low Dose Allergen Challenge.

SD-004-0601

A comparison of the relative systemic availability of budesonide in asthmatic patients afterinhalation from the current US version of Pulmicort Turbuhaler® and from two strengths of the new version of Pulmicort Turbuhaler.

SD-004-0620

A Placebo-Controlled Comparison of the Efficacy and Safety of the Current US Version of Pulmicort (Budesonide) Turbuhaler® and the New Version of Pulmicort Turbuhaler® in Asthmatic Adults Currently Treated with Inhaled Steroids

SD-004-0726

A Placebo-Controlled Comparison of the Efficacy, Safety, and Pharmacokinetics of the Current US Version of Pulmicort (Budesonide) Turbuhaler® and the New Version of Pulmicort Turbuhaler® in Asthmatic Children and Adolescents

SD-004-0732

A Safety and Efficacy Study of Two Dosage Levels of Pulmicort® Respules™ (budesonideinhalation suspension, 0.5 or 1.0 mg/day) versus Placebo in Infants Between the Ages of Six and TwelveMonths with Mild to Moderate Asthma.

SD-004-0758

Rates of Seroconversion Following Varicella Vaccination of Asthmatic Children Between the Ages of 1 and 8 Years Treated with PULMICORT RESPULES® Versus Non-steroidal Conventional Asthma Therapy

D5254C00763

An open single centre study to assess the concentration of budesonide in breast milk from asthmatic women on maintenance treatment with Pulmicort Turbuhaler® at the dose levels 200 or 400 µg bid.

 

SD-004-0764

 

A Randomized, Partly Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules® (budesonide inhalation suspension) at 0.5 mg qd, 1.0 mg qd, 1.0 mg bid, 2.0 mg bid and Pulmicort Turbuhaler® (budesonide) at 400 mcg bid in Adolescents (12 Years of Age and Older) and Adults with Moderate to Severe Asthma

SD-004-0765

A randomised, open, parallel-group, 24-week treatment, multicentre, Phase III study to investigate the efficacy and safety of 0.5-1.0 mg daily dose of budesonide inhalation suspension in Japanese children with bronchial asthma aged 6 months-4 years
SD-004-0768Investigation of safety and efficacy of budesonide inhalation suspension in the long-term use in Japanese children with bronchial asthma(open long-term extension study following study SD-004-0765)

SD-004-3064B

One year open follow-up to study; Effect of one year treatment with budesonide Turbuhaler® and nedocromil pMDI with spacer on bone mineral density, physical activity, and lung function in newly diagnosed asthmatic children.

SD-004-3066

Early intervention with anti-inflammatory treatment of childhood bronchial asthma. A comparison between budesonide and disodium cromoglycate.

AstraZeneca websites
Search
Corporate Responsibility
Quick links - Products
Page tools
>
>
>
>