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An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma

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NCT02219048

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Clinical Research Center of Alabama
Birmingham, Alabama, 35209 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
18-65 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
(according to GINA, 2014 definition of asthma),

- Pre bronchodilator FEV1 of greater than or equal to 50 and less that 80% of predicted.

- Subjects defined as GINA Step 4 on a stable dose of either fluticasone/salmeterol
combination therapy, or budesonide/formoterol combination therapy or
mometasone/formoterol combination therapy.

- Subjects who are defined as uncontrolled as evidenced by; Juniper Asthma Control
Questionnaire (5 item version, ACQ) score greater than or equal to 1.5 and less than
or equal to 3.0)

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

- Subjects diagnosed with chronic pulmonary disease (COPD) and/or other chronic
pulmonary diseases (eg, Occupational asthma, pulmonary fibrosis, bronchiectasis,
Allergic bronchopulmonary aspergillosis (ABPA), pneumoconiosis, sarcoidosis,
tuberculosis).

- Subjects who are current smokers.

NCT02219048
Pfizer
Terminated
An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma

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An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study To Assess The Efficacy, Safety, And Tolerability Of Pf-03715455 Administered Twice Daily By Inhalation For 12 Weeks In Subjects With Persistent Moderate To Severe Asthma Who Remain Uncontrolled Despite Treatment With Inhaled Corticosteroids (Ics) And Long-acting Beta2 Agonists (Laba)
The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe asthma when added to standard of care and during staged withdrawal of background therapy.
Study terminated on 7th April 2015. The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Placebo
    680 micrograms BID, Orally inhaled placebo for 12 weeks
  • Drug: PF-03715455
    680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks
  • Placebo Comparator: Placebo
    Matched blinded placebo
    Intervention: Drug: Placebo
  • Experimental: PF-03715455
    PF-03715455
    Intervention: Drug: PF-03715455
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
51
May 2015
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with a physician documented history or diagnosis of persistent asthma (according to GINA, 2014 definition of asthma),
  • Pre bronchodilator FEV1 of greater than or equal to 50 and less that 80% of predicted.
  • Subjects defined as GINA Step 4 on a stable dose of either fluticasone/salmeterol combination therapy, or budesonide/formoterol combination therapy or mometasone/formoterol combination therapy.
  • Subjects who are defined as uncontrolled as evidenced by; Juniper Asthma Control Questionnaire (5 item version, ACQ) score greater than or equal to 1.5 and less than or equal to 3.0)

Exclusion Criteria:

  • Subjects diagnosed with chronic pulmonary disease (COPD) and/or other chronic pulmonary diseases (eg, Occupational asthma, pulmonary fibrosis, bronchiectasis, Allergic bronchopulmonary aspergillosis (ABPA), pneumoconiosis, sarcoidosis, tuberculosis).
  • Subjects who are current smokers.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02219048
A9111007
INHALED P38I ASTHMA ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

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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