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

November 27, 2018 updated by: Pfizer

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Sequential enrollment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of Acute Asthma who have been prescribed oral Medrol tablets, will be enrolled

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 10 days after discharge
10 days after discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Relapse within 20 days of hospital discharge (Relapse is defined as above for Primary Endpoint).
Time Frame: 20 days after discharge
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.
Time Frame: 8 - 22 days after discharge
8 - 22 days after discharge
Change in FEV1 (Forced Expiratory Volume in 1 second) between start of therapy and first follow up visit.
Time Frame: 8 - 22 days after discharge
8 - 22 days after discharge
Proportion of patients controlled for asthma symptoms in the last 7 days after 10 days of hospital discharge
Time Frame: 10 days after discharge
10 days after discharge
Proportion of patients controlled for asthma symptoms in the last 7 days after 20 days of hospital discharge
Time Frame: 20 days after 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
Time Frame: 8 - 22 days after discharge
8 - 22 days after discharge
Physician-directed intensification of pharmacologic therapy between discharge from hospital and first follow up visit.
Time Frame: 8 - 22 days after discharge
8 - 22 days after discharge
Summary of adverse events in the study
Time Frame: Baseline to 20 days after discharge
Baseline to 20 days after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

September 3, 2009

First Submitted That Met QC Criteria

September 3, 2009

First Posted (Estimate)

September 4, 2009

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0121003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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