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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01899144 | Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients | PHASE2 | COMPLETED | 61 | — | — | Jul 1, 2013 | Oct 1, 2013 | Jan 26, 2022 | 22 | United States |
| NCT01058863 | A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma | PHASE2 | COMPLETED | 72 | — | — | Feb 1, 2010 | Jun 1, 2010 | Nov 9, 2021 | 13 | United States |
| NCT01844401 | Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma | PHASE1 | COMPLETED | 15 | — | — | Apr 1, 2013 | Oct 1, 2013 | Nov 14, 2013 | 1 | United States |
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...