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A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects (A7881006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00830427
Recruitment Status : Withdrawn
First Posted : January 27, 2009
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma, Bronchial Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases Drug: PF-00610355 Drug: PF - 00610355 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : April 15, 2009
Estimated Primary Completion Date : December 31, 2009
Estimated Study Completion Date : December 31, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: PF-00610355 Drug: PF-00610355
100 mcg, QD, dry powder inhaler
Experimental: PF - 00610355 Drug: PF - 00610355
600 mcg, QD, dry powder inhaler

Drug: PF - 00610355
300 mcg, QD, dry powder inhaler
Placebo Comparator: Placebo Other: Placebo
QD, dry powder inhaler


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline trough (24 hours post-dose) FEV1. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in heart rate. [ Time Frame: week 0, week 4 ]
  2. Change from baseline in trough FEV1. [ Time Frame: week 4 ]
  3. Maximum change from baseline in FEV1 from 0 to 6 hours post-dose. [ Time Frame: week 0,week 4 ]
  4. Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score. [ Time Frame: week 2, week 4 ]
  5. Pharmacokinetics of PF-00610355. [ Time Frame: week 0, week 4 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830427


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

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00830427    
Other Study ID Numbers: A7881006
2008-007183-42 ( EudraCT Number )
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
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/data_requests
Keywords provided by Pfizer:
asthma bronchial diseases
Additional relevant MeSH terms:
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Asthma
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bronchial Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases