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

NCT01299467 | Withdrawn Phase 1

• 1 other identifier: A9291006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Asthma

Keywords

Asthma; duration of action; allergen challenge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (6)

Dose 1 (0.5 hours)

EXPERIMENTAL

Drug: Active (PF-03526299)

Dose 1 (8 hours)

EXPERIMENTAL

Drug: Active (PF-03526299)

Dose 1 (placebo)

PLACEBO COMPARATOR

Drug: Placebo

Dose 2 (0.5 hr)

EXPERIMENTAL

Drug: Active (PF-03526299)

Dose 2 (8 hours)

EXPERIMENTAL

Drug: Active (PF-03526299)

Dose 2 (placebo)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Active (PF-03526299) 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 (0.5 hours)

Placebo DRUG

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

Dose 1 (placebo)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Asthma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: February 18, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 2, 2011

Record last verified: 2011-11