ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Effect of GW870086X on Allergen Challenge in Mild Asthmatics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00857857
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : February 20, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: GW870086X
Drug: FP
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Total 24 participants were enrolled from February-2009 to November-2009. ROTADISK™, DISKHALER™ and DISKUS™ were registered trademark product of GlaxoSmithKline.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with pre-bronchodilator forced expiratory volume in 1 second (FEV1) >65% predicted at Screening, positive wheal and flare reaction (>=3 millimeter) on skin prick testing, early asthmatic response (EAR) and late asthmatic response (LAR) had to include a fall in FEV1 of >=20%, >=15%, respectively from the post saline value were included.

Reporting Groups
  Description
Overall Study Participants were assigned to take 3 out of the 5 possible treatments for 13 days in a double-blind double dummy design: GW870086 0.25 milligram (mg), 1 mg, 3 mg once daily (OD), active control (fluticasone propionate 0.25 mg bi-daily [BID]) or placebo in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK, while fluticasone propionate as multi-dose powder inhaler (MDPI). GW870086 was administered via DISKHALER, while fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.

Participant Flow:   Overall Study
    Overall Study
STARTED   24 
COMPLETED   24 
NOT COMPLETED   0 



  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
Overall Study Participants were assigned to take 3 out of the 5 possible treatments for 13 days in a double-blind double dummy design: GW870086 0.25 mg, 1 mg, 3 mg OD, active control (fluticasone propionate 0.25mg BID) or placebo in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK, while fluticasone propionate as MDPI. GW870086 was administered via DISKHALER, while fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.

Baseline Measures
   Overall Study 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.4  (11.25) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      24 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      24 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period   [ Time Frame: 4-10 hours after allergen challenge on Day 13 of each treatment period ]

2.  Secondary:   LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period.   [ Time Frame: 4-10 hours after allergen challenge on Day 13 of each treatment period ]

3.  Secondary:   EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period.   [ Time Frame: 0-2 hours after challenge on Day 13 of each treatment period (approximately 17 weeks) ]

4.  Secondary:   Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period   [ Time Frame: Day 13 of each treatment period (approximately 17 weeks) ]

5.  Secondary:   Concentration of Exhaled NO Post-dose on Day 13 of Each Treatment Period   [ Time Frame: Day 13 of each treatment period (approximately 17 weeks) ]

6.  Secondary:   Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)   [ Time Frame: Up to 17 weeks ]

7.  Secondary:   Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

8.  Secondary:   Mean Values for Heart Rate   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

9.  Secondary:   Number of Participants With Electrocardiogram (ECG) Findings   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

10.  Secondary:   Change From Baseline in FEV1-allergen Challenge at Each Time Point   [ Time Frame: Up to Day 13 of each treatment period (approximately 17 weeks) ]

11.  Secondary:   Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

12.  Secondary:   Change From Baseline in FEV1-non Allergen Challenge   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

13.  Secondary:   Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

14.  Secondary:   Mean Laboratory Values for Hematocrit   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

15.  Secondary:   Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH)   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

16.  Secondary:   Mean Laboratory Values for Mean Corpuscle Volume (MCV)   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

17.  Secondary:   Mean Laboratory Values for Reticulocytes   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

18.  Secondary:   Mean Laboratory Values for Albumin and Total Protein   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

19.  Secondary:   Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

20.  Secondary:   Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

21.  Secondary:   Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium   [ Time Frame: Up to Day 14 of each treatment period (approximately 17 weeks) ]

22.  Secondary:   Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period.   [ Time Frame: Day 14 of each treatment period (approximately 17 weeks) ]

23.  Secondary:   Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-cell Counts of Eosinophils and Neutrophils   [ Time Frame: Day 14 of each treatment period (approximately 17 weeks) ]

24.  Secondary:   Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO)   [ Time Frame: Day 14 of each treatment period (approximately 17 weeks) ]

25.  Secondary:   Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8)   [ Time Frame: Day 14 of each treatment period (approximately 17 weeks) ]

26.  Secondary:   Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein   [ Time Frame: Day 14 of each treatment period (approximately 17 weeks) ]

27.  Secondary:   Number of Participants With Established Markers of Anti-inflammatory Activity in Sputum on Day 14-messenger Ribonucleic Acid (mRNA)   [ Time Frame: Day 14 of each treatment period (approximately 17 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  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

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


Publications:
Bareille P, Allen A, Hardes K, Donald A. Effect of repeat inhaled doses of GW870086 on the allergen-induced early and late asthmatic response in subjects with mild asthma. Curr Drug Ther. 2013;8(2)


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00857857     History of Changes
Other Study ID Numbers: 110762
First Submitted: March 5, 2009
First Posted: March 9, 2009
Results First Submitted: April 20, 2017
Results First Posted: February 20, 2018
Last Update Posted: February 20, 2018