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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02126839 | A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics | PHASE3 | COMPLETED | 186 | — | — | May 1, 2014 | Feb 1, 2015 | Nov 9, 2021 | 52 | United States, Thailand |
Following measurement of the baseline FEV1 and dose administration on Days 1 and 22, FEV1 values (highest of 3 acceptable maneuvers) will be obtained at 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±10), 120 (±10), 240 (±10), and 360 (±10) minutes after the completion of dosing. Predicted FEV1 values were computed and adjusted for age, height, and gender according to Eigen et al (Eigen et al 2001) for participants 4 to 5 years of age and to Quanjer et al (Quanjer et al 1995) for participants aged 6 to 11 years using ATS criteria (American Thoracic Society/European Respiratory Society Statement 2007).
| Arm | Type | Description |
|---|---|---|
| Placebo MDPI QID | PLACEBO_COMPARATOR | Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks. |
| Albuterol MDPI 180 mcg QID | EXPERIMENTAL | Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks. |
| Name | Type | Description |
|---|---|---|
| Albuterol MDPI | DRUG | 90 mcg/actuation of the multidose dry powder inhaler (MDPI). |
| Placebo | DRUG | Matching Placebo delivered via a multidose dry powder inhaler (MDPI). |
| ProAir HFA inhaler | DRUG | Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed. |
Inclusion Criteria: 1. Written informed consent/assent signed and dated by the patient and/or parent/caregiver/legal guardian (as appropriate) before conducting any study related procedure 2. Male or premenarchal female 4-11 years of age, inclusive, as of the screening visit (SV) 3. Has a documente...