Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ProAir HFA · 3 trials · 1 indication
Percent predicted FEV1: measured FEV1 as a percent of the "predicted values" for the patients of similar characteristics. Predicted FEV1 values were computed and adjusted for age, height, and gender for patients aged 4-5 years (Eigen et al 2001) and for patients aged 6-11 years (Quanjer et al 1995) using ATS/European Thoracic Society (ERS) criteria applicable to pediatric patients (ATS/ERS 2007). The percent predicted FEV1 (PPFEV1) area under the curve (AUC)0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose PPFEV1 values from each post-dose PPFEV1 determination.
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day. The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing.
Blood samples for plasma albuterol concentration determination will be drawn 5 (±2) minutes prior to dosing and at 30 (±2), 60 (±5), 120 (±10), 360 (±10), and 600 (±10) minutes after the completion of dosing.
Blood samples for plasma albuterol concentration determination will be drawn 5 (±2) minutes prior to dosing and at 30 (±2), 60 (±5), 120 (±10), 360 (±10), and 600 (±10) minutes after the completion of dosing.
| Arm | Type | Description |
|---|---|---|
| Albuterol Spiromax 90 mcg | EXPERIMENTAL | At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo. |
| Albuterol Spiromax 180 mcg | EXPERIMENTAL | At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo. |
| ProAir HFA 90 mcg | ACTIVE_COMPARATOR | At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo. |
| ProAir HFA 180 mcg | ACTIVE_COMPARATOR | At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo. |
| Placebo | PLACEBO_COMPARATOR | At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo. |
| Albuterol Spiromax® 90 mcg | EXPERIMENTAL | A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind. |
| Albuterol Spiromax® 180 mcg | EXPERIMENTAL | A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind. |
| ProAir® HFA 90 mcg | ACTIVE_COMPARATOR | A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind. |
| ProAir® HFA 180 mcg | ACTIVE_COMPARATOR | A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind. |
| Placebo Inhaler | PLACEBO_COMPARATOR | Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind. |
| Spiromax/ProAir | EXPERIMENTAL | Single dose of Albuterol Spiromax® 180 mcg followed by a 4 to 14 day washout period then a single dose of ProAir® HFA 180 mcg |
| ProAir/Spiromax | EXPERIMENTAL | Single dose of ProAir® HFA 180 mcg followed by a 4 to 14 day washout period then a single dose of Albuterol Spiromax® 180 mcg |
| Name | Type | Description |
|---|---|---|
| Albuterol Spiromax | DRUG | Albuterol Spiromax® Inhalation Aerosol contains 90 mcg albuterol per actuation orally inhaled in a single dose dry powder inhaler (DPI). Participants took doses at either the 90 or 180 mcg levels. If the higher level, two DPIs filled with Albuterol Spiromax® were used. |
| ProAir HFA | DRUG | ProAir® HFA Inhalation Aerosol contains 90 mcg albuterol per actuation orally inhaled in a single dose metered dose inhaler (MDI). Participants took doses at either the 90 or 180 mcg levels. If the higher level, two MDIs filled with ProAir HFA were used. |
| Placebo | DRUG | Single dose MDIs and DPIs containing placebo taken as a single orally-inhaled actuation each. |
| Albuterol Spiromax® | DRUG | Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg. |
| ProAir® HFA | DRUG | ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg. |
| Placebo Inhaler | OTHER | Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm. |
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 pre-menarchal female 4-11 years of age, inclusive, as of the screening visit 3. Has a documented ph...
ProAir HFA is an investigational small molecule being studied for the treatment of asthma. It is a hydrofluoroalkane formulation of albuterol, a bronchodilator. Clinical trials have evaluated its use in patients with persistent asthma, including pediatric patients aged 4 years and older.
ProAir HFA is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker TEVA. Teva has conducted clinical trials of ProAir HFA in the United States for the treatment of asthma.
ProAir HFA is in Phase 2 clinical development. It has completed three clinical trials, including two Phase 2 studies and one Phase 1 study. The drug is investigational and has not been approved for use. All completed trials were randomized, double-blind, and controlled.
ProAir HFA has been studied in three completed clinical trials. NCT01058863 was a Phase 2 dose-ranging study in patients aged 12 and older with persistent asthma. NCT01844401 was a Phase 1 pharmacokinetic and pharmacodynamic study in pediatric patients. NCT01899144 was a Phase 2 efficacy and safety comparison in pediatric patients.
ProAir HFA is a hydrofluoroalkane (HFA) formulation of albuterol. The clinical trials evaluated ProAir HFA alongside albuterol Spiromax, comparing their pharmacokinetic, pharmacodynamic, efficacy, and safety profiles in patients with asthma. ProAir HFA delivers albuterol as the active ingredient.