Phase 3
Completed N=160
Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics
Source: ClinicalTrials.gov NCT01747629 ↗Enrolled (actual)
160
Serious AEs
1.3%
Results posted
May 2015
Primary outcomePrimary: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period — 0.38; 1.30 L*hr — p=<0.0001
Summary
The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.
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 |
0.38; 1.30 | <0.0001 sig |
| SECONDARY Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1 |
0.58; 1.63 | <0.0001 sig |
| SECONDARY Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8 |
0.37; 1.15 | 0.0004 sig |
| SECONDARY Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85 |
0.20; 1.12 | <0.0001 sig |
| SECONDARY Participants With Adverse Events |
36; 22; 3; 1; 2; 1 | — |
| SECONDARY Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group |
81; 72; 0; 1; 0; 0 | — |
| SECONDARY Participants With Clinically Significant Vital Sign Assessments |
2; 3; 2; 2; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Drug Concentration (Cmax) for Albuterol on Days 1 and 8 |
347.2; 499.1 | — |
| SECONDARY Time to Observed Peak Plasma Concentration (Tmax) for Albuterol on Days 1 and 8 |
0.48; 0.44 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 (Pre-dose) up to 6 Hours Post-dose (AUC0-6) for Albuterol on Days 1 and 8 |
1325; 2163 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t) for Albuterol on Days 1 and 8 |
1747; 2165 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Infinity Post-dose(AUC0-inf) for Albuterol on Day 1 |
2278 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose(AUC0-24) for Albuterol on Day 8 |
3605 | — |
| SECONDARY Terminal Plasma Half-life (t1/2) for Albuterol on Days 1 and 8 |
4.7; 5.7 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent/assent
- At least 12 years of age at screening
- General good health
- Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility
- Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.
- Ability to perform spirometry in an acceptable manner as per protocol guidelines
- Other inclusion criteria apply
Exclusion Criteria
- A known hypersensitivity to albuterol or any of the excipients in the formulations.
- History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).
- 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 SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
- Hospitalization due to asthma exacerbation 2 or more times in the past year
- Initiation of immunotherapy or dose escalation during the study period
- Other exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT01747629). 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. Informational only — not medical advice.