A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications
Source: ClinicalTrials.gov NCT01576718 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period |
0.059; 0.101; 0.109; 0.125; 0.053 | 0.0604 |
| SECONDARY Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period |
10.48; 9.34; 10.03; 9.61; 2.24 | 0.1512 |
| SECONDARY Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period |
3.81; 6.41; 7.45; 10.97; 3.42 | 0.2879 |
| SECONDARY The Kaplan-Meier Estimate Of The Probability Of Remaining In The Study At Week 12 |
0.6872; 0.6330; 0.5852; 0.6109; 0.4722; 0.5657 | 0.0341 sig |
| SECONDARY Change From Baseline In The Percentage Of Rescue-Free 24-Hour Periods |
22.78; 26.41; 16.18; 28.05; 27.15; 15.87 | 0.88116 |
| SECONDARY Area Under The Plasma Concentration-Time Curve From Time Zero To The Time Of The Last Measurable Concentration (AUC0-t) |
117.6; 126.8; 292.0; 462.8; 162.3 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
19.1; 26.5; 55.2; 83.0; 32.5 | — |
| SECONDARY Time Of Maximum Observed Plasma Concentration (Tmax) |
1.0; 1.2; 2.2; 1.4; 1.8 | — |
| SECONDARY Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period |
31; 27; 34; 41; 33; 27 | — |
| SECONDARY Patients With Positive Swab Test Results for Oral Candidiasis |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 24-Hour Urinary Cortisol Excretion at Baseline, Week 12 and Endpoint |
65.3; 63.8; 66.6; 57.4; 74.3; 66.2 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent/assent signed and dated by the subject and/or parent /legal guardian before conducting any study related procedure.
- Male or female 12 years and older, as of the Screening Visit. Male or female 18 years and older, as of the Screening Visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adults only.
- General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study.
- Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH).
- Severity of Disease:
- A best forced expiratory volume in one second (FEV1) of 40%-85% of the predicted normal value during the Screening Visit. NHANES III predicted values will be used for subjects aged ≥12 years and adjustments to predicted values will be made for African American subjects. ATS/ERS 2005 criteria for acceptability, reproducibility, and end of test must be met for spirometry
- Reversibility of Disease: Demonstrated a ≥12% reversibility of FEV1 within 30 minutes following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 ≥12% then the subject is not eligible for the study and will not be allowed to re-screen. Reversibility values of 11.50 - 11.99 will be rounded to 12. Documented historical reversibility of ≥ 12 % within 3 months of the Screening Visit will be accepted.
- Current Asthma Therapy: Subjects will be required to be on a short acting β2 agonist and inhaled corticosteroid for a minimum of 8 weeks before the Screening Visit and have been maintained on a stable dose of inhaled corticosteroids for four weeks prior to the Screening Visit at one of the following doses:
- Fluticasone propionate HFA MDI ≥ 880 mcg/day
- Fluticasone propionate DPI≥ 1000 mcg/day
- Beclomethasone dipropionate DPI ≥ 2000 mcg/day
- Beclomethasone dipropionate HFA (QVAR)≥ 640 mcg/day
- Beclomethasone dipropionate HFA (Clenil Modulite)≥ 2000 mcg/day
- Budesonide DPI ≥ 1600 mcg/day
- Budesonide MDI ≥ 1600 mcg/day
- Flunisolide ≥ 2000 mcg/day
- Triamcinolone acetonide ≥ 2000 mcg /day
- Mometasone furoate DPI ≥ 880 mcg/day
- Ciclesonide HFA MDI ≥ 640 mcg/day
Exception 1: Based upon the investigator's judgment that there is no inherent harm in changing the subject's current ICS/LABA therapy and the subject provides consent, subjects on inhaled Fluticasone propionate/salmeterol DPI ≥ 1000 mcg/day, or Fluticasone propionate/salmeterol HFA ≥ 880 mcg/day, or Fluticasone propionate/Formoterol ≥ 1000 mcg/day,or Beclomethasone dipropionate/Formoterol ≥ 400 mcg/day, or Budesonide/formoterol HFA ≥ 640 mcg/day, or Budesonide/formoterol DPI ≥ 800 mcg/day, or Mometasone furoate/formoterol MDI ≥ 800 mcg/day or subjects on a qualifying ICS dose plus a long-acting β2-agonists (LABA) administered via separate inhalers, may be switched to a qualifying dose of fluticasone propionate provided the subjects will not participate in the PK portion of the study.
Exception 2: Subjects on a qualifying dose of fluticasone propionate who wish to participate in the PK portion of the study and who provide consent may have their fluticasone propionate switched to a different qualifying ICS (non-fluticasone propionate) at a pre-screening visit. The subject will be required to return to the clinic to complete the Screening Visit following a 1-week washout period.
- Short-Acting β2-Agonists: All subjects must be able to replace their current short-acting β2-agonists with albuterol/salbutamol inhalation aerosol at the Screening Visit for use as needed for the duration of the study. The use of spacer devices with the metered dose inhaler (MDI) will not be allowed during the study with exception of it's
Data sourced from ClinicalTrials.gov (NCT01576718). 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.