Phase 3
N=158
A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01424813 ↗Enrolled (actual)
158
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period — 0.28; 1.11 L*hr — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo MDPI (Drug); Albuterol MDPI (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period |
0.28; 1.11 | <0.0001 sig |
| SECONDARY Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1 |
0.52; 1.58 | <0.0001 sig |
| SECONDARY Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8 |
0.26; 0.99 | <0.0001 sig |
| SECONDARY Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85 |
0.06; 0.74 | <0.0001 sig |
| SECONDARY Participants With Adverse Events |
25; 22; 1; 1; 1; 1 | — |
| SECONDARY Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group |
76; 76; 0; 0; 1; 1 | — |
| SECONDARY Participants With Clinically Significant Vital Sign Assessments |
3; 0; 3; 1; 0; 1 | — |
Summary
The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.
Eligibility Criteria
Inclusion Criteria
- Written informed consent/assent
- General good health
- Persistent asthma, with an FEV1 50-80% predicted.
- Ability to perform spirometry in an acceptable manner as per protocol guidelines.
- Ability to perform PEFR with a handheld peak flow meter.
- Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.
- Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.
- Non-smokers.
- Capable of understanding the requirements, risks, and benefits of study participation.
- Other inclusion criteria apply.
Exclusion Criteria
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).
- A known hypersensitivity to albuterol or any of the excipients in the formulations.
- History of severe milk protein allergy.
- History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).
- Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.
- History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
- Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).
- Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
- Other exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT01424813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.