budesonide inhalation suspension / Generic mfg. - LARVOL DELTA

Navigation-assisted endoscopic U-flap technique and steroid-eluting stent for choanal atresia repair. (PubMed, Int J Pediatr Otorhinolaryngol) - "Navigation-assisted endoscopic endonasal resection of the atretic plate with two U-shaped mucoperiosteal flaps, a steroid-eluting stent, and post-operative transnasal glucocorticoid nebulization is a minimally invasive, precise and safe technique that is more effective in maintaining the patency of the neo-choana and is less recurrent in patients with CCA."

Journal • Retrospective data

Daewon Pharmaceutical to distribute AstraZeneca Korea’s asthma treatments (Korea Biomedical Review) - "AstraZeneca Korea and Daewon Pharmaceutical said that they have signed a partnership agreement for the distribution and sales of asthma treatments...Under the agreement, Daewon will take charge of distributing and marketing AstraZeneca’s asthma medications, Symbicort and Pulmicort Respules, in Korea...Symbicort is an inhaled respiratory treatment used for asthma and chronic obstructive pulmonary disease (COPD)...Pulmicort Respules is an ICS medication used to treat bronchial asthma and acute laryngotracheobronchitis in infants and children....Through this partnership, Daewon will be responsible for the distribution, marketing, and sales of these two drugs, while AstraZeneca will continue to manufacture them."

Commercial • Asthma • Chronic Obstructive Pulmonary Disease

Budesonide nasal irrigation for chronic rhinosinusitis: a meta-analysis of therapeutic outcomes and safety profile. (PubMed, Rhinology) - "BNI demonstrated improved SNOT-22 and LKES scores, with normal post-treatment IOP and cortisol levels, indicating a beneficial impact on CRS while maintaining safety."

Journal • Retrospective data • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy of Pulmicort Respules Combined with Azithromycin in the Treatment of Children with Recurrent Respiratory Tract Infection Caused by Mycoplasmal Pneumonia. (PubMed, Br J Hosp Med (Lond)) - "This study revealed that the incidence of complications in the observation group was 16.00%, which was significantly lower than the 37.50% in the reference group (p < 0.05). Conclusion In the short-term clinical treatment, the combination application of pulmicort respules and azithromycin can effectively improve the immune function of children with recurrent respiratory tract infection caused by MP and relieve their clinical symptoms."

Journal • Retrospective data • Cough • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • IL2 • IL6 • TNFA

The Budesonide in Babies (BiB) Trial (clinicaltrials.gov) - P3 | N=1160 | Active, not recruiting | Sponsor: NICHD Neonatal Research Network | Trial completion date: Sep 2027 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2024

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Pulmonary Disease • Respiratory Diseases

The Budesonide in Babies (BiB) Trial (clinicaltrials.gov) - P3 | N=1160 | Active, not recruiting | Sponsor: NICHD Neonatal Research Network | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Pulmonary Disease • Respiratory Diseases

Clinical features of plastic bronchitis in children after congenital heart surgery. (PubMed, Ital J Pediatr) - "Children with airway abnormalities or right ventricular dysfunction after CHS should be alerted to the development of PB. Pharmacological treatment such as anti-infection, corticosteroids, or improvement of right ventricular function is the basis of PB treatment, while fiberoptic bronchoscopy is an essential tool for the diagnosis and treatment of PB. ECMO assistance is a vital salvage treatment for recurrent critically ill PB patients."

Journal • Surgery • Cardiovascular • Critical care • Heart Failure • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Comparison of clinical outcomes following delivery of budesonide by both vibrating mesh nebulizer and jet nebulizer in premature infants with bronchopulmonary dysplasia. (PubMed, Front Pediatr) - "However, after 2 weeks of treatment, the oxygenation index (p = 0.012) and arterial partial pressure of carbon dioxide (p = 0.006) were more favorable in the VMN group compared to the JN group. Among premature infants with BPD on HFOV, for administration of budesonide inhalation suspension resulted in an improved oxygenation index and reduced arterial partial pressure of carbon dioxide when compared to a jet nebulizer, indicating superior therapeutic efficacy."

Clinical data • Journal • Bronchopulmonary Dysplasia • Critical care • Pulmonary Disease • Respiratory Diseases

Evaluating the affordability of asthma, chronic obstructive pulmonary disease, and cystic fibrosis medicines in a middle-income country. (PubMed, BMC Pulm Med) - "Results showed that the existing insurance coverage does not protect households from hardship, so more considerations are needed such as different insurance schedules and patient support programs."

Journal • Asthma • Chronic Obstructive Pulmonary Disease • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

BOREAS: Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics (clinicaltrials.gov) - P1/2 | N=23 | Completed | Sponsor: Aquilon Pharmaceuticals S.A. | Recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

The Budesonide in Babies (BiB) Trial (clinicaltrials.gov) - P3 | N=1160 | Recruiting | Sponsor: NICHD Neonatal Research Network | Trial completion date: Sep 2025 ➔ Sep 2027 | Trial primary completion date: Mar 2023 ➔ Sep 2025

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Pulmonary Disease • Respiratory Diseases

BOREAS: Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Aquilon Pharmaceuticals S.A. | Trial completion date: May 2022 ➔ Jan 2023 | Trial primary completion date: May 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

ARrest RESpiraTory Failure From PNEUMONIA (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Stanford University | Enrolling by invitation ➔ Recruiting | Trial primary completion date: Aug 2024 ➔ Jul 2025

Enrollment status • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

ARrest RESpiraTory Failure From PNEUMONIA (clinicaltrials.gov) - P3 | N=600 | Enrolling by invitation | Sponsor: Stanford University | Trial completion date: Jun 2024 ➔ Aug 2025 | Trial primary completion date: Apr 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Comparison of Nebulized Budesonide and Intranasal Budesonide Spray in Children With Adenotonsillar Hypertrophy (clinicaltrials.gov) - P3 | N=100 | Not yet recruiting | Sponsor: Second Xiangya Hospital of Central South University

New P3 trial

BORA: Single-dose AQ001S PK Study in Healthy Volunteers (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Aquilon Pharmaceuticals S.A. | Recruiting ➔ Completed | N=20 ➔ 29

Enrollment change • Trial completion

BOREAS: Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Aquilon Pharmaceuticals S.A. | Trial completion date: Nov 2021 ➔ May 2022 | Trial primary completion date: Nov 2021 ➔ May 2022

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome (clinicaltrials.gov) - P2; N=2; Terminated; Sponsor: The University of Texas Health Science Center, Houston; N=60 ➔ 2; Recruiting ➔ Terminated; Enrollment difficulties after the start of the COVID-19 pandemic.

Enrollment change • Trial termination • Acute Respiratory Distress Syndrome • Pediatrics • Pulmonary Disease • Respiratory Diseases • CXCL8 • IL6 • MMP9 • TNFA

BORA: Single-dose AQ001S PK Study in Healthy Volunteers (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Aquilon Pharmaceuticals S.A.

Clinical • New P1 trial

Treatment of pediatric mild persistent asthma with low-dose budesonide inhalation suspension vs. montelukast in China. (PubMed, World J Pediatr) - "Both treatments provided acceptable overall asthma control in children with mild persistent asthma; however, more reliever medication and more medical expenditures attributable to asthma were needed for BIS vs. montelukast in real-world settings, where factors such as compliance were also taken into account."

Clinical • Journal • Allergic Rhinitis • Asthma • Immunology • Pediatrics • Pulmonary Disease • Respiratory Diseases

BLANC: This is a Phase 1 Study to Compare Pharmacokinetics of BDA/MDI Compared to Pulmicort Respules in Children With Asthma Aged 4 to 8 Years (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Bond Avillion 2 Development LP; Recruiting ➔ Completed

Clinical • Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

BOREAS: Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics (clinicaltrials.gov) - P1/2; N=24; Recruiting; Sponsor: Aquilon Pharmaceuticals S.A.; Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

BOREAS: Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics (clinicaltrials.gov) - P1/2; N=24; Not yet recruiting; Sponsor: Aquilon Pharmaceuticals S.A.

Clinical • New P1/2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Sino Biopharmaceutical 2021 First Quarterly Profit attributable (Bloomberg.com) - "In the field of respiratory, the Group's first generic drug for allergic asthma, Tianqingsuchang (Budesonide Suspension for Inhalation), was launched, helping enrich the Group's respiratory product line and providing local patients with a new option for the first time other than imported products."

Generic launch • Asthma • Respiratory Diseases

[VIRTUAL] Physicochemical Stability and Compatibility of Long-Acting Muscarinic Antagonist Revefenacin Inhalation Solution and Inhaled Corticosteroid Budesonide Inhalation Suspension (ATS 2021) - "CONCLUSIONS Our results demonstrate the physicochemical compatibility and stability of the admixture of revefenacin inhalation solution and budesonide inhalation suspension for up to 24 hours at room temperature. Further study is required to evaluate the clinical safety and efficacy of these medicines in admixture."

Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases