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Phase 2 Completed N=28 Randomized Triple-blind Treatment

To Investigate the Effects of Altering the Time of Day of Dosing (Morning or Evening) With Fluticasone Furoate 100 Micrograms Once Daily Administered Via a Dry Powder Inhaler in Subjects With Asthma

Source: ClinicalTrials.gov NCT01808339 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Weighted Mean Forced Expiratory Volume in 1 Second (FEV1) Measured Over 24 Hours at Day 14 of Each Treatment Period — 3.303; 3.332; 3.227 Liters

Summary

This study will investigate the effects of altering the time of day of dosing (morning or evening) with Fluticasone Furoate 100 (FF 100) micrograms (mcg) once daily administered via a dry powder inhaler (DPI) in subjects with persistent bronchial asthma. This is a repeat-dose, double-blind, randomized, placebo-controlled, three-way crossover study to compare the effect of morning (AM) and evening (PM) dosing with FF 100 on lung function. Twenty-four male and female subjects with persistent bronchial asthma will be enrolled to ensure twenty evaluable subjects. The three treatments will be FF 100 AM (with placebo PM), FF 100 PM (with placebo AM) and matching placebo (AM and PM). All treatments will be administered for 14 (+/-2) days with 14 day run-in and 14 to 21 day washout periods. The total duration of the study will be approximately 13 to18 weeks for each subject.

Outcome Measures

OutcomeResultp-value
PRIMARY
Weighted Mean Forced Expiratory Volume in 1 Second (FEV1) Measured Over 24 Hours at Day 14 of Each Treatment Period
3.303; 3.332; 3.227
SECONDARY
Pre-treatment AM and PM Trough FEV1 on Day 14 of Each Treatment Period
3.299; 3.359; 3.286; 3.236; 3.290; 3.177
SECONDARY
Number of Participants With Any Adverse Event (AE)
18; 18; 16
SECONDARY
Peak Expiratory Flow (PEF)

Eligibility Criteria

Inclusion Criteria

  • Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases (pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma).
  • Male or female between 18 and 70 years of age inclusive, at the time of signing the informed consent.
  • A female subject is eligible to participate if she is:
  • Of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use contraception method, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
  • Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at screening and serum or urine hCG test prior to dosing and agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until completion of the follow up visit or has only same-sex partners, when this is her preferred and usual lifestyle.
  • All subjects must either be clinically stable on a low to mid dose inhaled corticosteroid (ICS) (with or without a short acting beta-2 receptor agonist [SABA]) such as Fluticasone Propionate (FP) 100 to250 mcg twice-daily (total daily dose 200 to 500 mcg) or equivalent, for at least 4 weeks preceding the screening visit or be clinically stable on a low dose ICS/ long acting beta-2 receptor agonist (LABA) combination, such as SERETIDE/ADVAIR 100/50 twice- daily or equivalent (administered either in combination or from separate inhalers), for at least 4 weeks preceding the screening visit. Higher ICS/LABA doses (i.e. equivalent to SERETIDE/ADVAIR 250/50 or 500/50) would not be acceptable. Subjects must refrain from using their LABA for at least 24 hour (h) prior to the screening visit
  • Subjects with a screening pre-bronchodilator FEV1 >= 60 percent of predicted. Predicted values will be based upon National Health and Nutrition Examination Survey (NHANES III).
  • During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of >= 12.0 percent over baseline and an absolute change of >= 200 mL within 60 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol solution).
  • All subjects must be able to replace all their current asthma treatments with albuterol/salbutamol aerosol inhaler at screening for use as needed for the run-in period and throughout the duration of the study. Subjects on LABAs must also withhold this for at least 24 h prior to the screening visit. Subjects will therefore be on SABA alone for the duration of the study, and on SABA and FF during the FF treatment periods. Subjects must be able to withhold albuterol/salbutamol for at least 6 h prior to screening and study visits.
  • Subjects who are current non-smokers and who have a pack history of = 50 kilograms (kg) and Body Mass Index (BMI) within the range 19.0 to29.9 kg/meter^2 (inclusive)
  • Based on single or averaged QT duration corrected for heart rate by Fridericia's formula (QTcF
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01808339). 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.

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