Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Symbicort · 2 trials · 2 indications
The annual COPD exacerbation rate was analyzed and compared between two arms. Annual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years. The annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model. Exacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations. Moderate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics. Severe exacerbation: symptoms that require hospitalization (including \>24 hours in ED/urgent care setting).
Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
| Arm | Type | Description |
|---|---|---|
| Symbicort pMDI | ACTIVE_COMPARATOR | Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation |
| Formoterol Turbuhaler | ACTIVE_COMPARATOR | Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation |
| 1 Symbicort/inhaler | ACTIVE_COMPARATOR | Symbicort BA MDI 2x160/4.5 μg twice daily |
| Symbicort/inhaler | ACTIVE_COMPARATOR | Symbicort AC pDMI 2x160/4.5 μg twice daily |
| Budesonide/inhaler | ACTIVE_COMPARATOR | Budesonide AC pMDI 2x160 μg twice daily |
| Name | Type | Description |
|---|---|---|
| Symbicort | DRUG | Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses |
| Formoterol turbohaler | DRUG | Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses |
| Placebo for Symbicort pMDI | OTHER | pMDI, aerosol for oral inhalation, placebo, 120 doses |
| Placebo for Formoterol Turbohaler | OTHER | PLacebo powder for oral inhalation, 60 doses |
| Budesonide | DRUG | Actuation counter pressured metered dose inhaler |
Inclusion Criteria: 3\. A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines. 4\. Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year). 5\. Post-bronc...
Symbicort is used for asthma and in patients with chronic obstructive pulmonary disease (COPD). It is a small molecule respiratory therapy developed by AstraZeneca PLC. Symbicort is administered via a metered dose inhaler and is currently in Phase 3 clinical development for these indications.
Symbicort is a combination inhaler containing budesonide, an inhaled corticosteroid, and formoterol, a long-acting beta2-agonist. It works by reducing airway inflammation and relaxing the muscles around the airways to improve breathing in asthma and COPD patients.
Symbicort is developed by AstraZeneca PLC, a multinational pharmaceutical company. AstraZeneca is listed on the stock exchange under the ticker symbol AZN. The company is conducting Phase 3 clinical trials to evaluate Symbicort for the treatment of asthma and COPD.
Symbicort is in Phase 3 clinical development for asthma and COPD. It is an investigational drug and has not yet been approved by regulatory authorities. Two Phase 3 trials have been completed, one in asthma and one in COPD, with a total enrollment of over 2,000 patients.
Symbicort has been studied in two completed Phase 3 trials. NCT01360021 compared a breath-actuated MDI Symbicort to Symbicort pMDI and budesonide pMDI in 214 asthma patients. NCT02157935 compared Symbicort pMDI to formoterol Turbuhaler in 2,026 COPD patients. Both trials were randomized, double-blind, and active-controlled.
Symbicort is a fixed-dose combination of budesonide and formoterol. Budesonide is an inhaled corticosteroid that reduces inflammation, and formoterol is a long-acting beta2-agonist that relaxes airway muscles. The combination is designed to provide both anti-inflammatory and bronchodilator effects in one inhaler.