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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00971893
• Other study ID #: B0121003
• Status: Withdrawn
• Start date: October 2009
• Est. completion date: April 2010

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Sequential enrollment

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Oral Methylprednisolone Tablets
Oral Methylprednisolone tablets given as per locally approved prescribing information

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

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

External Links

•   To obtain contact information for a study center near you, click here.