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

Sponsor

Pfizer (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00971893

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Oral Methylprednisolone Tablets

Detailed Description

Sequential enrollment

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients

Study Start Date :

Oct 1, 2009

Anticipated Primary Completion Date :

Apr 1, 2010

Anticipated Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Methylprednisolone Group	Drug: Oral Methylprednisolone Tablets Oral Methylprednisolone tablets given as per locally approved prescribing information

Arm

Intervention/Treatment

Methylprednisolone Group

Drug: Oral Methylprednisolone Tablets

Oral Methylprednisolone tablets given as per locally approved prescribing information

Outcome Measures

Primary Outcome Measures

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

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]
Change in FEV1 (Forced Expiratory Volume in 1 second) 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 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]
Physician-directed intensification of pharmacologic therapy between discharge from hospital and first follow up visit. [8 - 22 days after discharge]
Summary of adverse events in the study [Baseline to 20 days after discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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