Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01857323 · ClinicalTrials.gov registry record · Phase 3
Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)
A Phase 3 study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 317
- Enrollment target
- 20
- Study locations
NCT01857323: Completed Phase 3 study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01857323 is a Phase 3 study of Asthma and Chronic Obstructive Pulmonary Disease (COPD) that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 317 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01857323, a Phase 3 study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 317 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The purpose of this study is to evaluate the functionality, reliability, and accuracy of the Albuterol Spiromax inhaler integrated dose counter in a clinical setting.
Primary Outcome
The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures how often the dose cycle was not counted: the participant completes a full dose cycle (opens the mouthpiece cap, inhales the medication, and closes the mouthpiece cap) but the counter display does not
Conditions Studied
Interventions
- DRUG Albuterol Spiromax®
Study Locations (20)
California
- Teva Investigational Site 10637 - Costa Mesa
- Teva Investigational Site 10635 - Huntington Beach
- Teva Investigational Site 10647 - Rolling Hills Estates
- Teva Investigational Site 10643 - San Diego
- Teva Investigational Site 10644 - San Jose
Colorado
- Teva Investigational Site 10622 - Centennial
- Teva Investigational Site 10634 - Denver
- Teva Investigational Site 10645 - Wheat Ridge
Florida
- Teva Investigational Site 10633 - Miami
- Teva Investigational Site 10640 - Ormond Beach
North Carolina
- Teva Investigational Site 10613 - High Point
- Teva Investigational Site 10616 - Raleigh
Arizona
- Teva Investigational Site 10620 - Phoenix
Kansas
- Teva Investigational Site 10641 - Overland Park
Maryland
- Teva Investigational Site 10636 - Bethesda
Massachusetts
- Teva Investigational Site 10631 - North Dartmouth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
What the finished NCT01857323 record still lists
NCT01857323 is an interventional study that assigns participants to a tested intervention. The registered 317 participants enrollment target is mid-sized for trials with a published cap, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which Albuterol Spiromax® is the first listed.
NCT01857323 names 20 study sites across 12 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT01857323 about?
NCT01857323 is a clinical study titled "Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)". This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The purpose of this study is to evaluate the functionality, reliability, and accuracy of the Albuterol Spiromax inhaler i...
What is the current status of trial NCT01857323?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 317 participants. The study started on 2013-05. Estimated completion is 2013-09.
What conditions does trial NCT01857323 study?
This clinical trial studies the following conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD).
What interventions are being tested in trial NCT01857323?
The interventions under investigation include: Albuterol Spiromax® (DRUG).
Who is sponsoring clinical trial NCT01857323?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01857323 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01857323's enrollment target sits among peer trials
317 118th of 374 higher than 256 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
RECRUITING · Phase 3
-
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
RECRUITING · Phase 3
-
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
RECRUITING · Phase 3
-
A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
RECRUITING · Phase 3
-
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
RECRUITING · Phase 3
-
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04594642 · 317 participants · Phase 1
A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma
- NCT04977453 · 317 participants · Phase 1
GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
- NCT05137054 · 317 participants · Phase 1
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
- NCT05382754 · 317 participants · NA
Home Apnea Testing in CHildren Trial
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia