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

Last updated on November 21, 2019

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Withdrawn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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Descriptive Information
Brief Title  ICMJE A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects
Official Title  ICMJE A Phase Iib Randomised Double Blind, Placebo Controlled Parallel Group Study To Investigate The Efficacy And Safety Of Pf-00610355 Over 4 Weeks In Moderate Asthmatic Subjects.
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma, Bronchial
  • Lung Diseases, Obstructive
  • Respiratory Tract Diseases
  • Bronchial Diseases
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: PF-00610355
    Intervention: Drug: PF-00610355
  • Experimental: PF - 00610355
    Interventions:
    • Drug: PF - 00610355
    • Drug: PF - 00610355
  • Placebo Comparator: Placebo
    Intervention: Other: 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
Actual Enrollment  ICMJE
 (submitted: January 29, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2009)
350
Estimated Study Completion Date  ICMJE December 31, 2009
Estimated Primary Completion DateDecember 31, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00830427
Other Study ID Numbers  ICMJE A7881006
2008-007183-42 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2019

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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