Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Budesonide, budesonide
Budesonide/formoterol · 51 trials · 9 indications
The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbation risk over the 24 to 52 week treatment period.
Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment
An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.
Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.
Rate of exacerbations per subject-year
Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.
AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.
The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
FEV1
To determine and compare the systemic availability (Cmax) of budesonide and formoterol after single doses of Symbicort Aerosphere and Symbicort pMDI in participants 4 to less than 12 years of age with asthma.
To determine and compare the systemic availability (AUC0-6) of budesonide and formoterol after single doses of Symbicort Aerosphere and Symbicort pMDI in participants 4 to less than 12 years of age with asthma.
To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration
To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration
To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration
To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration
To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration
To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration
To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration
To characterize the PK of budesonide and albuterol delivered from BDA MDI after single dose administration
| Arm | Type | Description |
|---|---|---|
| BDA MDI | EXPERIMENTAL | BDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 μg) |
| AS MDI | ACTIVE_COMPARATOR | AS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg) |
| A/B - Treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg followed by treatment with Placebo | EXPERIMENTAL | Subjects randomized to receive a single dose of PT027 160/180 μg in treatment Period 1, and a single dose of Placebo in treatment Period 2. |
| B/A - Treatment with Placebo followed by treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg | EXPERIMENTAL | Subjects randomized to receive a single dose of Placebo in treatment Period 1, and a single dose of PT027 160/180 in treatment Period 2. |
| 1 | EXPERIMENTAL | Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily |
| 2 | ACTIVE_COMPARATOR | Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily |
| With Spacer | EXPERIMENTAL | Budesonide/formoterol pMDI 40/2.25ug + spacer |
| Without Spacer | EXPERIMENTAL | Budesonide/formoterol pMDI 40/2.25 ug |
| Symbicort | EXPERIMENTAL | Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID) |
| Budesonide | EXPERIMENTAL | Budesonide HFA pMDI 160 ug x 2 actuations BID |
| BUD - Budesonide | EXPERIMENTAL | Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily |
| CONV - Conventional Asthma Therapy | ACTIVE_COMPARATOR | Conventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. |
| 3 | EXPERIMENTAL | Bricasol® + Symbicort® |
| A | ACTIVE_COMPARATOR | budesonide 400yg + terbutaline 0.4 mg as-needed |
| B | ACTIVE_COMPARATOR | placebo + terbutaline 0.4 mg as-needed |
| C | ACTIVE_COMPARATOR | placebo + budesonide/formoterol 160/4.5 yg as-needed |
| Sequence AB | EXPERIMENTAL | In study period 1, participants will receive a single dose of treatment A (test formulation) and in study period 2, participants will receive a single dose of treatment B (reference formulation). |
| Sequence BA | EXPERIMENTAL | In study period 1, participants will receive a single dose of treatment B (reference formulation) and in study period 2, participants will receive a single dose of treatment A (test formulation). |
| Name | Type | Description |
|---|---|---|
| Budesonide/Albuterol metered dose inhaler, MDI | COMBINATION_PRODUCT | Combination Product (Drug + Device) |
| Albuterol sulfate metered dose inhaler, MDI | COMBINATION_PRODUCT | Combination Product (Drug + Device) |
| Budesonide/albuterol metered-dose inhaler 160/180 μg | DRUG | Budesonide/albuterol combination aerosol for inhalation, single dose (given as 2 actuations of 80/90 μg) |
| Placebo metered-dose inhaler | DRUG | Placebo aerosol for inhalation, single dose (given as 2 actuations) |
| Budesonide/formoterol (Symbicort Turbuhaler) | DRUG | 2x160/4.5 microgram, inhalation, twice daily, 12 weeks |
| Formoterol (Oxis Turbuhaler) | DRUG | 2 X 4.5 microgram, inhalation, twice daily, 12 weeks |
| Budesonide | DRUG | Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks |
| Pulmicort Turbuhaler | DRUG | Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler |
| Budesonide/formoterol pMDI 40/2.25ug + spacer | DRUG | - |
| Budesonide/formoterol pMDI 40/2.25 ug | DRUG | - |
| Budesonide/formoterol pMDI | DRUG | - |
| Budesonide HFA pMDI | DRUG | - |
| Budesonide/formoterol (SYMBICORT) pMDI | DRUG | Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID) |
| Formoterol Turbuhaler | DRUG | - |
| Conventional Asthma Therapy | DRUG | According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. |
| fluticasone | DRUG | - |
| budesonide/formoterol (Symbicort) | DRUG | inhalation therapy |
| budesonide (Pulmicort) | DRUG | inhalation |
| terbutaline sulfate (Bricasol) | DRUG | inhalation therapy |
| Budesonide/formoterol | DRUG | - |
| Theophylline | DRUG | - |
| Symbicort® Turbohaler® | DEVICE | - |
| Prednisolone | DRUG | - |
| Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy | DRUG | - |
| Budesonide/formoterol Turbuhaler | DRUG | - |
| Salmeterol/fluticasone Diskus | DRUG | - |
| Budesonide Turbuhaler (Pulmicort) | DRUG | - |
| Terbutaline Turbuhaler | DRUG | - |
| Budesonide pMDI | DRUG | - |
| Formoterol | DRUG | - |
| Terbutaline | DRUG | - |
| fluticasone/salmeterol (Advair) | DRUG | - |
| Symbicort pMDI + budesonide HFA pMDI | DRUG | Symbicort 2 X 160/4.5mcg \& budesonide HFA pMDI 4 X 160mcg |
| fluticasone/salmeterol (Advair Diskus) | DRUG | - |
| albuterol (Ventolin) | DRUG | - |
| budesonide and placebo | DRUG | - |
| Fluticasone propionate | DRUG | - |
| Placebo | DRUG | - |
| fluticasone/salmeterol | DRUG | - |
| albuterol | DRUG | - |
| budesonide/formoterol, 2x 200/6 microgram. 4 times daily | DRUG | - |
| prednisolone, 30 mg once daily and placebo | DRUG | - |
| Budesonide/formoterol fumarate Aerosphere | COMBINATION_PRODUCT | Participants will receive budesonide/formoterol fumarate aerosphere as oral inhalations. |
| Budesonide/formoterol fumarate pMDI | COMBINATION_PRODUCT | Participants will receive budesonide/formoterol fumarate pMDI as oral inhalations. |
| budesonide/albuterol sulfate metered dose inhaleor (BDA MDI) | COMBINATION_PRODUCT | BDA MDI 160 μg/180 μg (single dose administered as 2 actuations of 80 μg/90 μg) |
Inclusion Criteria: 1. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1 2. Receiving 1 of the scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1 3. Pre-bronchodilator FEV1 of ≥ 40% to \< 90% predicted norm...