| 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. |
| D5252C00002 | A 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. |
| D5252C00006 | An 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-2103 | An 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-004-0768 | Investigation 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. |