A Study To Assess The Duration Of Action Of PF-03526299 In Asthmatic Subjects Following Allergen Challenge

Study Overview
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Brief Summary
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The purpose of this study is to find out how long the effect of PF-03526299 last after it is inhaled by assessing the lung function of mild asthma patients after they have been exposed to allergen

Detailed Description
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To assess duration of action of the compound in suppressing the early and late allergen response in asthma patients

Official Title
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A Randomized, Double-Blind, Third Party Open, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study To Determine The Duration Of Action Of Inhaled Doses Of PF-03526299 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects

Conditions
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Asthma

Intervention / Treatment
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* Drug: Active (PF-03526299)
* Drug: Active (PF-03526299)
* Drug: Placebo
* Drug: Active (PF-03526299)
* Drug: Active (PF-03526299)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and/or female subjects between the ages of 18 and 60 years, inclusive. A history or diagnosis of asthma that requires the use of beta 2 agonist bronchodilators (eg Salbutamol). Women who could become pregnant must use appropriate birth control throughout the study and pregnancy tests must be negative on entering the study and prior to dosing in the clinic. Exclusion Criteria: Subjects who have been hospitalized for the treatment of asthma within three months prior to study entry, or have been hospitalized more than twice in last 12 months. Subjects who have experienced a lower respiratory tract infection (eg bronchitis or pneumonia) or significant asthma instability in the 4 weeks prior to study entry. Severe additional disease other than asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 (0.5 hours)<br> | Drug: Active (PF-03526299)<br>* Capsules for inhalation, 1.396 mg twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge<br>|
| Experimental: Dose 1 (8 hours)<br> | Drug: Active (PF-03526299)<br>* Capsules for inhalation, 1.396 mg twice a day for up to 12 days. Last dose given 8 hrs before allergen challenge<br>|
| Placebo Comparator: Dose 1 (placebo)<br> | Drug: Placebo<br>* Capsules for inhalation, Placebo, twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge<br>|
| Experimental: Dose 2 (0.5 hr)<br> | Drug: Active (PF-03526299)<br>* Capsules for inhalation, 4.188 mg twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge<br>|
| Experimental: Dose 2 (8 hours)<br> | Drug: Active (PF-03526299)<br>* Capsules for inhalation, 4.188 mg twice a day for up to 12 days. Last dose given 8hrs before allergen challenge<br>|
| Placebo Comparator: Dose 2 (placebo)<br> | Drug: Placebo<br>* Capsules for inhalation, Placebo, twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether inhaled PF-03526299 has a sustained duration of action, using allergen-induced EAR in mild allergic asthmatics as a biomarker of response. |  | Up to 13 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of inhaled PF-03526299 after multiple dosing on allergen-induced EAR in mild allergic asthmatics. |  | Up to 13 days | 
| To determine whether inhaled PF-03526299 has a sustained duration of action, using allergen-induced LAR in mild allergic asthmatics as a biomarker of response. |  | Up to 13 days | 
| To investigate the safety, toleration and pharmacokinetics of an inhaled dose of PF-03526299 |  | Up ro 13 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, duration of action, allergen challenge