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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Active (PF-03526299)
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: February 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 (0.5 hours) 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
Experimental: Dose 1 (8 hours) 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
Placebo Comparator: Dose 1 (placebo) Drug: Placebo
Capsules for inhalation, Placebo, twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge
Experimental: Dose 2 (0.5 hr) 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
Experimental: Dose 2 (8 hours) 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
Placebo Comparator: Dose 2 (placebo) Drug: Placebo
Capsules for inhalation, Placebo, twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299467

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01299467     History of Changes
Other Study ID Numbers: A9291006
Study First Received: January 3, 2011
Last Updated: November 30, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Pfizer:
Asthma
duration of action
allergen challenge

ClinicalTrials.gov processed this record on October 16, 2014