Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ProAir HFA inhaler · 1 trial · 1 indication
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...
ProAir HFA inhaler is used for the treatment of asthma. It is a small molecule medication being developed by Teva Pharmaceutical Industries Limited (TEVA) for the respiratory therapeutic area. The drug is currently in Phase 3 clinical development for this indication.
ProAir HFA inhaler is a small molecule medication. The specific molecular target or target class for this drug has not been disclosed in the available information, so its exact mechanism of action is not detailed here.
ProAir HFA inhaler is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker symbol TEVA. The drug is currently in Phase 3 clinical development for the treatment of asthma.
ProAir HFA inhaler is in Phase 3 clinical development. It is an investigational drug for the treatment of asthma and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 3 trial.
ProAir HFA inhaler has one completed Phase 3 clinical trial, identified as NCT02126839. This was a chronic-dose safety and efficacy study of albuterol multi-dose dry powder inhaler in pediatric asthmatics, enrolling 186 participants in the United States and Thailand.
ProAir HFA inhaler is a formulation of albuterol, as indicated by the clinical trial title for the drug. The trial studied albuterol multi-dose dry powder inhaler in pediatric asthmatics, suggesting that ProAir HFA inhaler contains albuterol as its active ingredient.