Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients
Public ClinicalTrials.gov record NCT01899144. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Single-Dose, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Period Crossover, Dose-Ranging Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® HFA in Pediatric Patients With Persistent Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01899144
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 4 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2013
- Primary completion
- Sep 30, 2013
- Completion
- Sep 30, 2013
- Last update posted
- Jan 25, 2022
2013
United States locations
- U.S. sites
- 22
- U.S. states
- 12
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 10598 | Birmingham | Alabama | — | — |
| Teva Investigational Site 10593 | Little Rock | Alaska | — | — |
| Teva Investigational Site 10610 | Costa Mesa | California | — | — |
| Teva Investigational Site 10582 | Huntington Beach | California | — | — |
| Teva Investigational Site 10606 | Orange | California | — | — |
| Teva Investigational Site 10597 | San Jose | California | — | — |
| Teva Investigational Site 10596 | Jacksonville | Florida | — | — |
| Teva Investigational Site 10599 | Lawrenceville | Georgia | — | — |
| Teva Investigational Site 10580 | Savannah | Georgia | — | — |
| Teva Investigational Site 10592 | Normal | Illinois | — | — |
| Teva Investigational Site 10602 | Missoula | Montana | — | — |
| Teva Investigational Site 10578 | Raleigh | North Carolina | — | — |
| Teva Investigational Site 10577 | Oklahoma City | Oklahoma | — | — |
| Teva Investigational Site 10589 | Medford | Oregon | — | — |
| Teva Investigational Site 10604 | Portland | Oregon | — | — |
| Teva Investigational Site 10591 | Charleston | South Carolina | — | — |
| Teva Investigational Site 10609 | Orangeburg | South Carolina | — | — |
| Teva Investigational Site 10579 | Spartanburg | South Carolina | — | — |
| Teva Investigational Site 10588 | Boerne | Texas | — | — |
| Teva Investigational Site 10605 | New Braunfels | Texas | — | — |
| Teva Investigational Site 10583 | San Antonio | Texas | — | — |
| Teva Investigational Site 10576 | Waco | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01899144, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 25, 2022 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01899144 live on ClinicalTrials.gov.