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Proventil HFA · 1 trial · 1 indication
The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs). The maximum percent change from baseline in FEV1 observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values. The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age.
The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs). The maximum percent change from baseline in the PEF observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline PEF was defined as the average of the test-day pre-dose baseline PEF values. The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age.
| Arm | Type | Description |
|---|---|---|
| Albuterol | EXPERIMENTAL | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. HFA-MDI refers to a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. |
| Placebo | PLACEBO_COMPARATOR | A placebo of a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Placebo-HFA-MDI.") |
| Name | Type | Description |
|---|---|---|
| Albuterol | DRUG | Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days. |
| Placebo | DRUG | Placebo HFA MDI four times a day (q.i.d) for 21 days. |
| Proventil® HFA | DRUG | Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance. |
Inclusion Criteria: * Male and female child aged 4-11 years, inclusive Asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening. Exclusion Criteria: * Hospitalization for acute asthma exacerbation greater than two years in 12 months prior to scree...
Proventil HFA is used for the treatment of asthma. It is a small molecule respiratory medication being developed by Teva Pharmaceutical Industries Limited (TEVA). The drug is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved for commercial use.
Proventil HFA is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma.
Proventil HFA is in Phase 3 clinical development. It is an investigational drug for asthma and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is not yet available for commercial use.
Proventil HFA has one completed Phase 3 clinical trial, identified as NCT00577655, titled "Albuterol HFA MDI in Pediatric Participants With Asthma." This randomized, double-blind, placebo-controlled trial enrolled 103 participants aged 4 years and older in the United States.
Proventil HFA contains albuterol, as indicated by the clinical trial title referencing "Albuterol HFA MDI." The drug is a hydrofluoroalkane (HFA) metered-dose inhaler formulation of albuterol, which is a bronchodilator used to treat asthma symptoms.