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A Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian Patients

Last updated on November 15, 2019

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Study Location
Contact
1-800-718-1021
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
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- To be eligible for enrollment in this study, patients must be prescribed oral Medrol®
tablets (4mg and 16 mg) for acute asthma as per the locally approved prescribing
information. The prescription of Medrol® will be separated from the decision to
include the patient in the study.

- Medrol® tablets, will be prescribed to the patient by the physician according to
his/her usual practice. The decision to prescribe Medrol® tablet will necessarily
precede and will be independent of the decision to enroll patient into the study. Only
those patients who have been prescribed Medrol® tablets will be evaluated for their
potential eligibility for the study

- Only those patients, who are ready and willing to sign an informed consent, will be
included in the study

- Subject can be contacted through telephone

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

- Based upon history or physical exam in the emergency department (ED) or Clinic,
subjects with known or suspected cause of pulmonary symptoms other than asthma, such
as COPD, CHF, pneumonia, pulmonary embolism, or angioedema

- Any contraindication to Medrol tablet use. Contraindications of Medrol use are
systemic fungal infections and known hypersensitivity to components

NCT00971893
Pfizer
Withdrawn
A Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian Patients

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Descriptive Information
Brief TitleA Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian Patients
Official TitleA Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients
Brief SummaryThe present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients.
Detailed DescriptionSequential enrollment
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients of Acute Asthma who have been prescribed oral Medrol tablets, will be enrolled
ConditionAsthma
InterventionDrug: Oral Methylprednisolone Tablets
Oral Methylprednisolone tablets given as per locally approved prescribing information
Study Groups/CohortsMethylprednisolone Group
Intervention: Drug: Oral Methylprednisolone Tablets
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 StatusWithdrawn
Actual Enrollment
 (submitted: November 27, 2018)
0
Original Estimated Enrollment
 (submitted: September 3, 2009)
100
Estimated Study Completion DateApril 2010
Estimated Primary Completion DateApril 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • To be eligible for enrollment in this study, patients must be prescribed oral Medrol® tablets (4mg and 16 mg) for acute asthma as per the locally approved prescribing information. The prescription of Medrol® will be separated from the decision to include the patient in the study.
  • Medrol® tablets, will be prescribed to the patient by the physician according to his/her usual practice. The decision to prescribe Medrol® tablet will necessarily precede and will be independent of the decision to enroll patient into the study. Only those patients who have been prescribed Medrol® tablets will be evaluated for their potential eligibility for the study
  • Only those patients, who are ready and willing to sign an informed consent, will be included in the study
  • Subject can be contacted through telephone

Exclusion Criteria:

  • Based upon history or physical exam in the emergency department (ED) or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema
  • Any contraindication to Medrol tablet use. Contraindications of Medrol use are systemic fungal infections and known hypersensitivity to components
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00971893
Other Study ID NumbersB0121003
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

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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