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

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NCT01299467

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01299467
Pfizer
Withdrawn
A Study To Assess The Duration Of Action Of PF-03526299 In Asthmatic Subjects Following Allergen Challenge

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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
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
To assess duration of action of the compound in suppressing the early and late allergen response in asthma patients
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Asthma
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2012
February 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01299467
A9291006
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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