A Phase 2 interventional study of Albuterol Spiromax and ProAir HFA in Asthma, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 22 sites in United States. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 2, Interventional, and Treatment
This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with persistent asthma. The primary purpose of this study is to compare the efficacy and safety of Albuterol Spiromax with that of ProAir HFA in pediatric asthma patients at 2 delivered dose levels equivalent to 90 mcg and 180 mcg of albuterol base.
The study consists of a screening visit (SV) followed by up to 16 days by a treatment period comprising 5 visits (TV1-TV5). The treatment period visits will each be separated by a washout period lasting 2-7 days. During each treatment period visit, the forced expiratory volume in 1 second (FEV1) will be determined at 30 minutes and again immediately prior to the commencement of study medication administration, and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes after completion of study medication administration.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 61 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Has forced expiratory volume in 1 second (FEV1) 60-90% predicted for age, height, and gender at the screening visit based on the pediatric population standards as per protocol.
Notes: (1) Predicted values of 59.50-59.99% may be rounded up to 60% and 90.01-90.49% rounded down to 90%. (2) Patients who at the screening visit fail to meet the predicted spirometry values for study entry may be allowed a single attempt to re-qualify on another day, but they must re-qualify no later than 16 days following the first attempt.
Has the ability to demonstrate acceptable and reproducible inhalation technique with the Spiromax and metered dose inhaler (MDI) devices
Exclusion Criteria:
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.
Drug: Albuterol Spiromax · Drug: Placebo
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.
Drug: Albuterol Spiromax · Drug: Placebo
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.
Drug: ProAir HFA · Drug: Placebo
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.
Drug: ProAir HFA · Drug: Placebo
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.
Drug: Placebo
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.
Also known as: Spiromax®, albuterol
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.
Also known as: ProAir®
Single dose MDIs and DPIs containing placebo taken as a single orally-inhaled actuation each.
Baseline-Adjusted Area-Under-The-Percent-Predicted Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose
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.
Time frame: Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati
Baseline-Adjusted Area-Under-The- Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose (FEV1 AUC0-6)
FEV1 AUC0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose FEV1 values from each post-dose FEV1 determination.
Time frame: Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati
Participants With Treatment-Emergent Adverse Events
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual activities). Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time frame: Day 1 up to Day 35
Of the 102 patients screened, 61 patients at 14 centers in the US met entry criteria and were considered to be eligible for enrollment into the study. 41 patients were not enrolled: 33 were excluded due to inclusion criteria, 1 patient withdrew consent, 3 patients were lost to follow-up before the baseline visit, and 4 patients for other reasons.
| Milestone | All Participants |
|---|---|
| Started | 61 |
| Completed | 61 |
| Not completed | 0 |
| Milestone | All Participants |
|---|---|
| Started | 61 |
| Completed | 60 |
| Not completed | 1 |
| Withdrew: Other | 1 |
| Milestone | All Participants |
|---|---|
| Started | 60 |
| Completed | 58 |
| Not completed | 2 |
| Withdrew: Other | 2 |
| Milestone | All Participants |
|---|---|
| Started | 58 |
| Completed | 58 |
| Not completed | 0 |
| Milestone | All Participants |
|---|---|
| Started | 58 |
| Completed | 57 |
| Not completed | 1 |
| Withdrew: Other | 1 |
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.
| %predicted FEV1*hour | Albuterol Spiromax 90 mcg | Albuterol Spiromax 180 mcg | ProAir HFA 90 mcg | ProAir HFA 180 mcg | Placebo |
|---|---|---|---|---|---|
| Baseline-Adjusted Area-Under-The-Percent-Predicted Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose | 46.6 ± 6.27 | 48.0 ± 6.24 | 37.9 ± 6.25 | 49.1 ± 6.26 | 25.4 ± 6.25 |
FEV1 AUC0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose FEV1 values from each post-dose FEV1 determination.
| L*hour | Albuterol Spiromax 90 mcg | Albuterol Spiromax 180 mcg | ProAir HFA 90 mcg | ProAir HFA 180 mcg | Placebo |
|---|---|---|---|---|---|
| Baseline-Adjusted Area-Under-The- Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose (FEV1 AUC0-6) | 0.88 ± 0.14 | 0.93 ± 0.14 | 0.74 ± 0.14 | 0.93 ± 0.14 | 0.48 ± 0.14 |
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual activities). Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
| participants | Albuterol Spiromax 90 mcg | Albuterol Spiromax 180 mcg | ProAir HFA 90 mcg | ProAir HFA 180 mcg | Placebo |
|---|---|---|---|---|---|
| Treatment-related AE | 0 | 2 | 5 | 1 | 1 |
| Severe TEAE | 0 | 0 | 0 | 0 | 0 |
| Related TEAE | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 | 0 |
| Serious AE | 0 | 0 | 0 | 0 | 0 |
| TEAE leading to withdrawal | 0 | 0 | 0 | 0 | 0 |
Collected over Day 1 up to Day 35. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Albuterol Spiromax 90 mcg | — | 0/61 (0%) | 0/61 (0%) |
| Albuterol Spiromax 180 mcg | — | 0/61 (0%) | 0/61 (0%) |
| ProAir HFA 90 mcg | — | 0/61 (0%) | 3/61 (4.9%) |
| ProAir HFA 180 mcg | — | 0/61 (0%) | 0/61 (0%) |
| Placebo | — | 0/61 (0%) | 0/61 (0%) |
| Event | Albuterol Spiromax 90 mcg | Albuterol Spiromax 180 mcg | ProAir HFA 90 mcg | ProAir HFA 180 mcg | Placebo |
|---|---|---|---|---|---|
| HeadacheNervous system disorders | 0/61 | 0/61 | 3/61 | 0/61 | 0/61 |
Randomized participants
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 9.0 ± 1.6 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 23 |
| Male | 38 |
| Race/Ethnicity, Customized(participants) | All Participants |
|---|---|
| White | 28 |
| Black | 29 |
| Other | 4 |
| Weight(kg) | All Participants |
|---|---|
| Mean | 38.2 ± 12.8 |
| Height(cm) | All Participants |
|---|---|
| Mean | 138.7 ± 10.2 |
| Body Mass Index(kg/m^2) | All Participants |
|---|---|
| Mean | 19.5 ± 4.35 |
| Duration of Asthma(participants) | All Participants |
|---|---|
| None | 0 |
| <3 months | 0 |
| 3 to <6 months | 0 |
| 6 months to <1 year | 1 |
| 1 to <5 years | 22 |
| 5 to <10 years | 30 |
| 10 to <15 years | 8 |
| Duration of Previous Dry-Powder Inhaler (DPI) Experience(participants) | All Participants |
|---|---|
| None | 46 |
| <3 months | 2 |
| 3 to <6 months | 1 |
| 6 months to <1 year | 3 |
| 1 to <5 years | 9 |
| 5 to <10 years | 0 |
| 10 to <15 years | 0 |
1 further baseline measures are reported on the registry.
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Teva Branded Pharmaceutical Products R&D, Inc.