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

NCT ID: NCT01299467

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-02-29

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

Conditions

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Asthma

Keywords

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Asthma duration of action allergen challenge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dose 1 (0.5 hours)

Group Type EXPERIMENTAL

Active (PF-03526299)

Intervention Type DRUG

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

Dose 1 (8 hours)

Group Type EXPERIMENTAL

Active (PF-03526299)

Intervention Type DRUG

Capsules for inhalation, 1.396 mg twice a day for up to 12 days. Last dose given 8 hrs before allergen challenge

Dose 1 (placebo)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Dose 2 (0.5 hr)

Group Type EXPERIMENTAL

Active (PF-03526299)

Intervention Type DRUG

Capsules for inhalation, 4.188 mg twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge

Dose 2 (8 hours)

Group Type EXPERIMENTAL

Active (PF-03526299)

Intervention Type DRUG

Capsules for inhalation, 4.188 mg twice a day for up to 12 days. Last dose given 8hrs before allergen challenge

Dose 2 (placebo)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Active (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

Intervention Type DRUG

Active (PF-03526299)

Capsules for inhalation, 1.396 mg twice a day for up to 12 days. Last dose given 8 hrs before allergen challenge

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Active (PF-03526299)

Capsules for inhalation, 4.188 mg twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge

Intervention Type DRUG

Active (PF-03526299)

Capsules for inhalation, 4.188 mg twice a day for up to 12 days. Last dose given 8hrs before allergen challenge

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9291006&StudyName=A%20Study%20To%20Assess%20The%20Duration%20Of%20Action%20Of%20PF-03526299%20In%20Asthmatic%20Subjects%20Following%20Allergen%20Challenge

To obtain contact information for a study center near you, click here.

Other Identifiers

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A9291006

Identifier Type: -

Identifier Source: org_study_id