Trial Profile
Phase 3 Study to Evaluate the Chronic-dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 13 Nov 2021
Price :
$35
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At a glance
- Drugs Salbutamol (Primary)
- Indications Asthma
- Focus Registrational; Therapeutic Use
- Sponsors Teva Branded Pharmaceutical Products R&D; 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.
- 05 Aug 2008 The expected study completion date has changed from May 2008 to Jul 2008 as reported by ClinicalTrials.gov.
- 05 Aug 2008 Patient number amended from 100 to 104, as reported by ClinicalTrials.gov.