Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Gail Gauvreau, McMaster University
ClinicalTrials.gov Identifier:
NCT00716963
First received: July 14, 2008
Last updated: April 30, 2015
Last verified: April 2015
Results First Received: April 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Mild Asthma
Interventions: Drug: Fluticasone propionate (Flovent Diskus) 250 mcg
Drug: budesonide 400 mcg
Other: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Fluticasone/Budesonide/Placebo Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
Fluticasone/Placebo/Budesonide Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
Budesonide/Fluticasone/Placebo Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
Budesonide/Placebo/Fluticasone Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
Placebo/Fluticasone/Budesonide Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
Placebo/Budesonide/Fluticasone Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.

Participant Flow:   Overall Study
    Fluticasone/Budesonide/Placebo     Fluticasone/Placebo/Budesonide     Budesonide/Fluticasone/Placebo     Budesonide/Placebo/Fluticasone     Placebo/Fluticasone/Budesonide     Placebo/Budesonide/Fluticasone  
STARTED     2     1     1     1     1     1  
COMPLETED     1     1     1     1     1     1  
NOT COMPLETED     1     0     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
Screening/Baseline Participants No text entered.

Baseline Measures
    Screening/Baseline Participants  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     0  
Gender  
[units: participants]
 
Female     4  
Male     3  



  Outcome Measures
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1.  Primary:   The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Fall in FEV1.   [ Time Frame: Before inhalation 3 hours ]

2.  Primary:   The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Fall in FEV1.   [ Time Frame: 7 hours after challenge ]

3.  Secondary:   The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).   [ Time Frame: Before inhalation both evaluations (0 hours) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)   [ Time Frame: sputum @ 7 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)   [ Time Frame: 24 hours methacholine and sputum ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Gail Gauvreau
Organization: McMaster University
phone: 905-525-9140 ext 22791
e-mail: gauvreau@mcmaster.ca


Publications:
Gauvreau GM, Boulet LP, Hessel EM, Watson RM, Milot J, Coffman RL, et al. A phase 2, randomized, observer-blind, placebo-controlled study of the efficacy, safety and tolerability of inhaled 1018 ISS immunostimulatory oligonucleotide in subjects with mild to moderate asthma. Am.J.Respir.Crit Care Med. 171, A81. 2005. Ref Type: Abstract


Responsible Party: Gail Gauvreau, McMaster University
ClinicalTrials.gov Identifier: NCT00716963     History of Changes
Other Study ID Numbers: AZ2008lr
Study First Received: July 14, 2008
Results First Received: April 14, 2015
Last Updated: April 30, 2015
Health Authority: Canada: Health Canada