Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00577655 | Albuterol HFA MDI in Pediatric Participants With Asthma | PHASE3 | COMPLETED | 103 | — | — | Aug 1, 2007 | Jul 1, 2008 | Nov 12, 2021 | 13 | United States |
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...