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A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bronchial Asthma, Obstructive Lung Diseases, Respiratory Tract Diseases, Bronchial Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with a physician documented history or diagnosis of persistent asthma for at
least 6 months prior to Screening Visit 1.

- Trough FEV1 must be 50-100% of predicted at Screening Visit 1.

- Subjects who have been maintained on a stable dose of ICS over the previous month
prior to screening.

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

- Subjects who have had a severe asthma exacerbation in the 2 months prior to screening.

- Subjects meeting any of the criteria of 'very poorly controlled' according to the NIH
EPR 3 guidelines.

- Subjects with evidence or history of cardiovascular disease including angina,
myocardial, infarction, clinically significant cardiac arrhythmia (eg, atrial
fibrillation, atrial flutter,supraventricular tachycardia, ventricular tachycardia),
systemic hypertension (SBP > 160 mmHg or DBP >100mmHg), pulmonary hypertension or
cerebrovascular disease (including transient ischaemic attacks).

NCT00830427
Pfizer
Withdrawn
A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects

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A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects
A Phase IIb Randomised, Double Blind, Placebo Controlled Parallel Group Study To Investigate The Efficacy And Safety Of PF-00610355 Over 4 Weeks In Moderately Asthmatic Subjects.
This study (A7881006) is the first multiple dose study in moderate asthmatic subjects and aims to determine the safety and efficacy of PF-00610355 when subjects take PF-00610355 on a daily basis for 4 weeks in subjects maintained on inhaled corticosteroid.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Asthma, Bronchial
  • Lung Diseases, Obstructive
  • Respiratory Tract Diseases
  • Bronchial Diseases
  • Drug: PF-00610355
    100 mcg, QD, dry powder inhaler
  • Drug: PF - 00610355
    600 mcg, QD, dry powder inhaler
  • Other: Placebo
    QD, dry powder inhaler
  • Drug: PF - 00610355
    300 mcg, QD, dry powder inhaler
  • Experimental: PF-00610355
    Intervention: Drug: PF-00610355
  • Experimental: PF - 00610355
    Interventions:
    • Drug: PF - 00610355
    • Drug: PF - 00610355
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
350
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with a physician documented history or diagnosis of persistent asthma for at least 6 months prior to Screening Visit 1.
  • Trough FEV1 must be 50-100% of predicted at Screening Visit 1.
  • Subjects who have been maintained on a stable dose of ICS over the previous month prior to screening.

Exclusion Criteria:

  • Subjects who have had a severe asthma exacerbation in the 2 months prior to screening.
  • Subjects meeting any of the criteria of 'very poorly controlled' according to the NIH EPR 3 guidelines.
  • Subjects with evidence or history of cardiovascular disease including angina, myocardial, infarction, clinically significant cardiac arrhythmia (eg, atrial fibrillation, atrial flutter,supraventricular tachycardia, ventricular tachycardia), systemic hypertension (SBP > 160 mmHg or DBP >100mmHg), pulmonary hypertension or cerebrovascular disease (including transient ischaemic attacks).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00830427
A7881006
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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