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

NCT00971893

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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

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Advanced Information
Descriptive Information
Brief Title A Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian Patients
Official Title A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients
Brief Summary The present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients.
Detailed Description Sequential enrollment
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients of Acute Asthma who have been prescribed oral Medrol tablets, will be enrolled
Condition Asthma
Intervention Drug: Oral Methylprednisolone Tablets
Oral Methylprednisolone tablets given as per locally approved prescribing information
Study Groups/Cohorts Methylprednisolone 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 Status Withdrawn
Actual Enrollment
 (submitted: November 27, 2018)
0
Original Estimated Enrollment
 (submitted: September 3, 2009)
100
Estimated Study Completion Date April 2010
Estimated Primary Completion Date April 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
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00971893
Other Study ID Numbers B0121003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018