Phase 2
Completed N=72
Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects
Source: ClinicalTrials.gov NCT01772368 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Standardized Baseline-Adjusted Area Under the Curve For Forced Expiratory Volume In 1 Second Over 12 Hours Post-dose (FEV1 AUC0-12) — 52.13; 203.84; 248.98; 279.69 mL — p=<0.0001
Summary
The primary objective of this study is to evaluate the dose response, efficacy, and safety of 4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax® Inhalation Powder (FS Spiromax) when administered as a single dose in subjects 12 years of age and older with persistent asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standardized Baseline-Adjusted Area Under the Curve For Forced Expiratory Volume In 1 Second Over 12 Hours Post-dose (FEV1 AUC0-12) |
52.13; 203.84; 248.98; 279.69; 303.43; 245.56 | <0.0001 sig |
| SECONDARY Change From Baseline at 12 Hours Post-Dose in Forced Expiratory Volume in One Second (FEV1) By Treatment |
11.53; 128.49; 170.51; 209.85; 238.30; 170.54 | <0.0001 sig |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) of Salmeterol |
32.8; 69.9; 133.5; 309.3; 173.5 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Salmeterol |
16.0; 35.8; 67.5; 154.5; 42.3 | — |
| SECONDARY Time of Maximum Observed Plasma Concentration (Tmax) of Salmeterol |
0.1; 0.1; 0.1; 0.1; 0.5 | — |
| SECONDARY Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period |
2; 2; 3; 1; 1; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent/assent
- General good health
- Diagnosis of asthma as defined by the National Institutes of Health (NIH)
- A best FEV1 of 40%-85% of the predicted normal value during the screening visit (SV)
- Subjects need to demonstrate a ≥ 15% reversibility of FEV1 within 30 minutes following 4 inhalations of albuterol inhalation aerosol (if required, spacers are permitted for reversibility testing) at the SV.
- Other inclusion criteria apply
Exclusion Criteria
- History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
- Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the SV.
- 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.
- Taking long-acting β-agonists within 2 weeks of the SV
- Other exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT01772368). 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.