A Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian Patients
NCT00971893
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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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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 | 0 | |||
Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | November 2018 |