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

Withdrawn

• Conditions: Asthma
• Interventions: Drug: Oral Methylprednisolone Tablets

• Registration Number: NCT00971893
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Study Start: 2009-10
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Methylprednisolone Group	Oral Methylprednisolone Tablets	-

Primary Outcome Measures

Name	Time	Method
Relapse within 10 days of hospital discharge (Relapse is defined as unscheduled care at a doctor's office, a clinic, or Emergency Department (ED) for symptoms of persistent or worsening asthma after hospital discharge)	10 days after discharge

Secondary Outcome Measures

Name	Time	Method
Relapse within 20 days of hospital discharge (Relapse is defined as above for Primary Endpoint).	20 days after discharge
Change in PEFR (Peak Expiratory Flow Rate measured in Percentage of expected) between start of therapy and first follow up visit.	8 - 22 days after discharge
Proportion of patients controlled for asthma symptoms in the last 7 days after 10 days of hospital discharge	10 days after discharge
Proportion of patients controlled for asthma symptoms in the last 7 days after 20 days of hospital discharge	20 days after discharge
Change in FEV1 (Forced Expiratory Volume in 1 second) between start of therapy and first follow up visit.	8 - 22 days after discharge
Change in frequency in last 24 hours of inhalational Beta 2 agonist therapy between start of therapy and first follow up visit	8 - 22 days after discharge
Summary of adverse events in the study	Baseline to 20 days after discharge
Physician-directed intensification of pharmacologic therapy between discharge from hospital and first follow up visit.	8 - 22 days after discharge