Pharmacokinetics and Pharacodynamics of GW642444 in Paedetric Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01453296
First received: September 1, 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: GW642444
Drug: Placebo

  Participant Flow
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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 treatment sequences (Vilanterol [VI] 25 micrograms [µg] followed by matching Placebo; matching placebo followed by VI 25 µg) in a 1:1 ratio in an AB or BA sequence.

Reporting Groups
  Description
Sequence 1: VI 25 µg Followed by Placebo Participants received vilanterol (VI) 25 micrograms (µg) and matching placebo in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via ae Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
Sequence 2: Placebo Followed by VI 25 µg Participants received placebo and VI 25 µg in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.

Participant Flow for 3 periods

Period 1:   Treatment Period 1
    Sequence 1: VI 25 µg Followed by Placebo     Sequence 2: Placebo Followed by VI 25 µg  
STARTED     14     14  
COMPLETED     13     13  
NOT COMPLETED     1     1  
Adverse Event                 0                 1  
Met Protocol-Defined Stopping Criteria                 1                 0  

Period 2:   Washout Period
    Sequence 1: VI 25 µg Followed by Placebo     Sequence 2: Placebo Followed by VI 25 µg  
STARTED     13     13  
COMPLETED     13     13  
NOT COMPLETED     0     0  

Period 3:   Treatment Period 2
    Sequence 1: VI 25 µg Followed by Placebo     Sequence 2: Placebo Followed by VI 25 µg  
STARTED     13     13  
COMPLETED     11     13  
NOT COMPLETED     2     0  
Adverse Event                 1                 0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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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
VI 25 µg/Placebo or Placebo/VI 25 µg Participants received either vilanterol (VI) 25 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by a repeat dose of the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled VI 25 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.

Baseline Measures
    VI 25 µg/Placebo or Placebo/VI 25 µg  
Number of Participants  
[units: participants]
  28  
Age  
[units: Years]
Mean ± Standard Deviation
  8.0  ± 1.90  
Gender  
[units: Participants]
 
Female     10  
Male     18  
Race/Ethnicity, Customized  
[units: Participants]
 
African American/African Heritage     5  
White - White/Caucasian/European Heritage     22  
Mixed Race     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 8)/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 49) ]

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 49) ]

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 49) ]

5.  Primary:   Hematocrit Value at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 49) ]

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 49) ]

7.  Primary:   Mean Corpuscle Hemoglobin (MCH) Value at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 49) ]

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 49) ]

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 49) ]

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 49) ]

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 49) ]

12.  Primary:   Peak Expiratory Flow on Day 1, Day 8, and Day 14 of the Respective Treatment Period   [ Time Frame: Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49) ]

13.  Primary:   Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, Day 8, and Day 14 of the Respective Treatment Period   [ Time Frame: Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49) ]

14.  Primary:   Maximum Heart Rate 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 49) ]

15.  Primary:   Weighted Mean Heart Rate 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 49) ]

16.  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 49) ]

17.  Primary:   Weighted Mean 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 49) ]

18.  Secondary:   AUC(0-t) and AUC(0-8) on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 49) ]

19.  Secondary:   Cmax on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 49) ]

20.  Secondary:   Tmax, t1/2, and t at Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 49) ]

21.  Secondary:   Blood Glucose and Potassium on Day 14 of the Respective Treatment Period   [ Time Frame: Day 14 of the respective treatment period (up to Study Day 49) ]

22.  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 49) ]

23.  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 49) ]

24.  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 49) ]

25.  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 49) ]

26.  Secondary:   Inhalation Time 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 49) ]

27.  Secondary:   Inhaled 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 49) ]

28.  Secondary:   Peak Pressure Drop 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 49) ]

29.  Secondary:   Total Emitted Dose (TED) 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 49) ]

30.  Secondary:   Ex-throat Dose (ETD) and ETD <2 Microns 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 49) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: NCT01453296     History of Changes
Other Study ID Numbers: 112776
Study First Received: September 1, 2011
Results First Received: June 6, 2013
Last Updated: August 15, 2013
Health Authority: United States: Food and Drug Administration