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Label indication PULMICORT RESPULES ® is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Maintenance Treatment of Asthma PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years… FDA label
Also known as Pulmicort (budesonide) Respules, Budesonide inhalation suspension
Pulmicort Respules · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Pulmicort (budesonide) Respules | DRUG | - |
Inclusion Criteria: \- 1. Clinical benefit from continued treatment with budesonide inhalation suspension was expected in patients with bronchial asthma participating in study SD-004-0765, as judged by the investigator(s) at the completion of that study (Visit 11, Week 24), and the patient's caregi...
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| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
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| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
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| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Pulmicort Respules is a small molecule respiratory therapy developed by AstraZeneca PLC (ticker AZN) for asthma. It is an inhalation suspension form of budesonide studied in pediatric patients, including Japanese children with bronchial asthma. It is also known as Pulmicort (budesonide) Respules.
Pulmicort Respules is used for asthma, specifically bronchial asthma in children. The clinical development program evaluated it in Japanese children with bronchial asthma, with study participants as young as 13 months of age. It is an inhaled suspension formulation of budesonide.
Pulmicort Respules is made by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the developer of the budesonide inhalation suspension product for asthma.
Pulmicort Respules has been studied in Phase 3 clinical development. The Phase 3 trial in the program is completed, and no active trials are currently listed. It is an investigational-stage asset in the tracked clinical program, not a newly approved product in this dataset.
Pulmicort Respules was evaluated in one completed Phase 3 trial, NCT00232648, titled Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma. The trial enrolled 54 participants in Japan, included both sexes, and had a minimum age of 13 months.
Yes, Pulmicort Respules is also known as Pulmicort (budesonide) Respules. Both names refer to the same budesonide inhalation suspension product developed by AstraZeneca PLC for asthma.