Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01128595
First received: May 20, 2010
Last updated: August 22, 2013
Last verified: June 2013
Results First Received: June 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: FF/GW642444M
Drug: GW642444M
Drug: Fluticasone Furoate
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants meeting all of the inclusion criteria and none of the exclusion criteria during the Screening Visit, conducted 14-42 days prior to the first dose of study medication, entered a 14-day Run-in Period. Participants were then randomized to 4 Treatment Periods, each lasting 21 days and separated by a nominal washout period of 21-35 days.

Reporting Groups
  Description
Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg Participants received Vilanterol (VI) 25 micrograms (µg), placebo, fluticasone furoate (FF) 100 µg, and FF/VI 100/25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg Participants received FF/VI 100/25 µg, FF 100 µg, placebo, and VI 25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg Participants received placebo, FF/VI 100/25 µg, VI 25 µg, and FF 100 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo Participants received FF 100 µg, VI 25 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.

Participant Flow for 7 periods

Period 1:   Treatment Period 1
    Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg     Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg     Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg     Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo  
STARTED     7     6     7     7  
COMPLETED     7     6     7     7  
NOT COMPLETED     0     0     0     0  

Period 2:   Washout Period 1
    Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg     Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg     Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg     Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo  
STARTED     7     6     7     7  
COMPLETED     7     6     7     7  
NOT COMPLETED     0     0     0     0  

Period 3:   Treatment Period 2
    Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg     Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg     Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg     Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo  
STARTED     7     6     7     7  
COMPLETED     7     6     7     7  
NOT COMPLETED     0     0     0     0  

Period 4:   Washout Period 2
    Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg     Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg     Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg     Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo  
STARTED     7     6     7     7  
COMPLETED     7     6     7     7  
NOT COMPLETED     0     0     0     0  

Period 5:   Treatment Period 3
    Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg     Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg     Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg     Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo  
STARTED     7     6     7     7  
COMPLETED     7     5     7     7  
NOT COMPLETED     0     1     0     0  
Withdrawal by Subject                 0                 1                 0                 0  

Period 6:   Washout Period 3
    Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg     Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg     Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg     Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo  
STARTED     7     5     7     7  
COMPLETED     7     5     7     7  
NOT COMPLETED     0     0     0     0  

Period 7:   Treatment Period 4
    Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg     Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg     Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg     Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo  
STARTED     7     5     7     7  
COMPLETED     7     5     7     7  
NOT COMPLETED     0     0     0     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.
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Reporting Groups
  Description
Placebo, FF/VI 100/25 µg OD, FF 100 µg OD, VI 25 µg All participants received one of the following four treatments in one of four treatment periods once daily (OD) from the Dry Powder Inhaler (DPI) for 21 days: Placebo; Fluticasone Furoate /Vilanterol (FF/VI) 100/25 microgram (µg) dry inhalation powder; Fluticasone Furoate (FF) 100 µg dry inhalation powder; and Vilanterol (VI) 25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the four following sequences: (1) VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg; (2) FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg; (3) Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg; (4) FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo. The four treatment periods were separated by a washout period of 21 to 35 days.

Baseline Measures
    Placebo, FF/VI 100/25 µg OD, FF 100 µg OD, VI 25 µg  
Number of Participants  
[units: participants]
  27  
Age  
[units: Years]
Mean ± Standard Deviation
  30.8  ± 7.46  
Gender  
[units: Participants]
 
Female     8  
Male     19  
Race/Ethnicity, Customized  
[units: participants]
 
White/Caucasian/European Heritage     25  
East Asian Heritage     1  
Mixed Race     1  



  Outcome Measures
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1.  Primary:   Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period   [ Time Frame: Day 21 of each treatment period (up to Study Day 197) ]

2.  Primary:   LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period   [ Time Frame: Day 21 of each treatment period (up to Study Day 197) ]

3.  Primary:   Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period   [ Time Frame: Day 21 of each treatment period (up to Study Day 197) ]

4.  Primary:   EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period   [ Time Frame: Day 21 of each treatment period (up to Study Day 197) ]

5.  Secondary:   Maximum Percent Change From Saline in FEV1 Between 0-2 Hrs, Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period   [ Time Frame: Day 21 of each treatment period (up to Study Day 197) ]

6.  Secondary:   Provocative Concentration of Methacholine Estimated to Result in a 20% Reduction in FEV1 (PC20) on Day 22 of Each Treatment Period   [ Time Frame: Day 22 of each treatment period (up to Study Day 198) ]


  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: NCT01128595     History of Changes
Other Study ID Numbers: 113126
Study First Received: May 20, 2010
Results First Received: June 6, 2013
Last Updated: August 22, 2013
Health Authority: New Zealand: Medsafe
United States: Food and Drug Administration
Sweden: Medical Products Agency
Australia: Therapeutic Goods Administration