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

NCT00971893 | Withdrawn

• 1 other identifier: B0121003
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Asthma

Keywords

Acute Exacerbation of Bronchial Asthma Acute Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

Methylprednisolone Group

Drug: Oral Methylprednisolone Tablets

Interventions

Oral Methylprednisolone Tablets DRUG

Oral Methylprednisolone tablets given as per locally approved prescribing information

Methylprednisolone Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Asthma

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: November 29, 2018

Record last verified: 2018-11