Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Inhaled Fluticasone Furoate/Vilanterol Safety and Tolerability, PK and PD Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01453023
First received: October 6, 2011
Last updated: August 15, 2013
Last verified: June 2013
Results First Received: June 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Fluticasone Furoate
Drug: Fluticasone Furoate/Vilanterol

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled into one of two cohorts based upon age; the younger cohort was enrolled after a review of the safety/pharmacokinetic data of at least six participants from the older cohort. Each participant was assigned to treatment randomly; assignment was not to be influenced by whether participants were in Cohort 1 or Cohort 2.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A Baseline assessment was carried out on Day 1 of the first treatment period. Participants were then randomized to one of the two possible treatments fluticasone furoate [FF] 100 µg/Vilanterol [VI] 25 µg.or FF 100 µg, followed by a cross over after a washout period of at least 7 days.

Reporting Groups
  Description
FF 100 µg/VI 25 µg in TP 1 and FF 100 µg in TP 2 Participants received fluticasone furoate (FF) 100 micrograms (µg)/Vilanterol (VI) 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
FF 100 µg in TP 1 and FF 100 µg/VI 25 µg in TP 2 Participants received FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.

Participant Flow for 3 periods

Period 1:   Treatment Period (TP) 1
    FF 100 µg/VI 25 µg in TP 1 and FF 100 µg in TP 2     FF 100 µg in TP 1 and FF 100 µg/VI 25 µg in TP 2  
STARTED     13     13  
COMPLETED     12     12  
NOT COMPLETED     1     1  
Protocol Violation                 1                 0  
Met Protocol-defined Stopping Criteria                 0                 1  

Period 2:   Washout Period
    FF 100 µg/VI 25 µg in TP 1 and FF 100 µg in TP 2     FF 100 µg in TP 1 and FF 100 µg/VI 25 µg in TP 2  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  

Period 3:   Treatment Period 2
    FF 100 µg/VI 25 µg in TP 1 and FF 100 µg in TP 2     FF 100 µg in TP 1 and FF 100 µg/VI 25 µg in TP 2  
STARTED     12     12  
COMPLETED     12     11  
NOT COMPLETED     0     1  
Protocol Violation                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
FF 100 µg/VI 25 µg and FF 100 µg in TPs 1 and 2 All participants who received FF 100 µg/VI 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2 or FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.

Baseline Measures
    FF 100 µg/VI 25 µg and FF 100 µg in TPs 1 and 2  
Number of Participants  
[units: participants]
  26  
Age  
[units: Years]
Mean ± Standard Deviation
  8.1  ± 1.97  
Gender  
[units: Participants]
 
Female     11  
Male     15  
Race/Ethnicity, Customized  
[units: Participants]
 
African American/African Heritage     3  
White - Arabic/North African Heritage     1  
White - White/Caucasian/European Heritage     21  
African American/African Heritage & White     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period   [ Time Frame: From the start of study medication until Week 11 (Visit 9)/Early Withdrawal ]

2.  Primary:   Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

3.  Primary:   Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

4.  Primary:   Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

5.  Primary:   Hematocrit Values at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

6.  Primary:   Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

7.  Primary:   Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

8.  Primary:   Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

9.  Primary:   Albumin and Total Protein Values at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

10.  Primary:   Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

11.  Primary:   Total Bilirubin, Direct Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

12.  Primary:   Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period   [ Time Frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 63) ]

13.  Primary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 14 of the Respective Treatment Period   [ Time Frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 63) ]

14.  Primary:   Change From Baseline in Heart Rate at Day1 and Day 14 of the Respective Treatment Period   [ Time Frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 63) ]

15.  Primary:   Maximum QTcF at Day 1 and Day 14 of the Respective Treatment Period   [ Time Frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 63) ]

16.  Secondary:   AUC(0-t) and AUC(0-4) of FF on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

17.  Secondary:   Cmax of FF on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

18.  Secondary:   Tmax and Tlast of FF on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

19.  Secondary:   AUC(0-t) and AUC(0-4) of VI on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

20.  Secondary:   Cmax of VI on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

21.  Secondary:   Tmax and Tlast of VI on Day 1 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

22.  Secondary:   Blood Glucose and Potassium Values on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

23.  Secondary:   Serum Cortisol (SC) Weighted Mean (0–12 Hours) on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

24.  Secondary:   Average Oropharyngeal Cross-sectional Area on Day 1 and Day 14 of the Respective Treatment Period   [ Time Frame: Day 1 and Day 14 of the respective treatment period (up to Study Day X) ]

25.  Secondary:   Distance of Assessment on Day 1 and Day 14 of the Respective Treatment Period   [ Time Frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 63) ]

26.  Secondary:   Oropharyngeal Volume on Day 1 and Day 14 of the Respective Treatment Period   [ Time Frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 63) ]

27.  Secondary:   Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Day 1 and Day 14 of the Respective Treatment Period   [ Time Frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 63) ]

28.  Secondary:   Inhalation Time on Days 1 and 14 of of the Respective Treatment Period   [ Time Frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 63) ]

29.  Secondary:   Inhaled Volume on Days 1 and 14 of the Respective Treatment Period   [ Time Frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 63) ]

30.  Secondary:   Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period   [ Time Frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 63) ]

31.  Secondary:   Total Emitted Dose (TED) on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]

32.  Secondary:   Ex-throat Dose (ETD) and ETD <2 Microns on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 63) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01453023     History of Changes
Other Study ID Numbers: 112777
Study First Received: October 6, 2011
Results First Received: June 6, 2013
Last Updated: August 15, 2013
Health Authority: United States: Food and Drug Administration