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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01299467

First received: January 3, 2011

Last updated: November 30, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 3, 2011

Last Updated Date

November 30, 2011

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: Up to 13 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01299467 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine the effect of inhaled PF-03526299 after multiple dosing on allergen-induced EAR in mild allergic asthmatics. [ Time Frame: Up to 13 days ] [ Designated as safety issue: No ]
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. [ Time Frame: Up to 13 days ] [ Designated as safety issue: No ]
To investigate the safety, toleration and pharmacokinetics of an inhaled dose of PF-03526299 [ Time Frame: Up ro 13 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Dose 1 (0.5 hours)
Intervention: Drug: Active (PF-03526299)
Experimental: Dose 1 (8 hours)
Intervention: Drug: Active (PF-03526299)
Placebo Comparator: Dose 1 (placebo)
Intervention: Drug: Placebo
Experimental: Dose 2 (0.5 hr)
Intervention: Drug: Active (PF-03526299)
Experimental: Dose 2 (8 hours)
Intervention: Drug: Active (PF-03526299)
Placebo Comparator: Dose 2 (placebo)
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

February 2012

Estimated Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01299467

Other Study ID Numbers ^ICMJE

A9291006

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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