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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01299467

Enrollment

Registered

2011-02-18

Start date

2011-02-28

Completion date

2012-02-29

Last updated

2011-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, duration of action, allergen challenge

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

Interventions

DRUGActive (PF-03526299)

Capsules for inhalation, 1.396 mg twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge

DRUGPlacebo

Capsules for inhalation, Placebo, twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026