Chronic-Dose Safety and Efficacy Study of a Bronchodilator Inhaler in Pediatric Asthmatics
Phase of Trial: Phase III
Latest Information Update: 29 Apr 2016
At a glance
- Drugs Salbutamol (Primary)
- Indications Asthma
- Focus Registrational; Therapeutic Use
- Sponsors Teva Pharmaceutical Industries
- 29 Apr 2016 The US FDA has approved ProAir RespiClick (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
- 30 Oct 2014 According to Teva Pharmaceutical Industries pipeline, company plans to submit an NDA to the FDA in 2015, based on the results of this study.
- 16 Aug 2012 Actual end date (1 Jul 2008) added as reported by ClinicalTrials.gov.