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

Phase 1

Withdrawn

• Conditions: Asthma
• Interventions: Drug: Active (PF-03526299); Drug: Placebo

• Registration Number: NCT01299467
• Lead Sponsor: Pfizer

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2011-01-03
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-30
• Last Update Posted: 2011-12-02
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dose 1 (0.5 hours)	Active (PF-03526299)	-
Dose 1 (8 hours)	Active (PF-03526299)	-
Dose 1 (placebo)	Placebo	-
Dose 2 (0.5 hr)	Active (PF-03526299)	-
Dose 2 (8 hours)	Active (PF-03526299)	-
Dose 2 (placebo)	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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