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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00971893
First received: September 3, 2009
Last updated: October 29, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Oral Methylprednisolone Tablets
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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) [ Time Frame: 10 days after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse within 20 days of hospital discharge (Relapse is defined as above for Primary Endpoint). [ Time Frame: 20 days after discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of patients controlled for asthma symptoms in the last 7 days after 10 days of hospital discharge [ Time Frame: 10 days after discharge ] [ Designated as safety issue: No ]
  • Proportion of patients controlled for asthma symptoms in the last 7 days after 20 days of hospital discharge [ Time Frame: 20 days after discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Physician-directed intensification of pharmacologic therapy between discharge from hospital and first follow up visit. [ Time Frame: 8 - 22 days after discharge ] [ Designated as safety issue: No ]
  • Summary of adverse events in the study [ Time Frame: Baseline to 20 days after discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Methylprednisolone Group Drug: Oral Methylprednisolone Tablets
Oral Methylprednisolone tablets given as per locally approved prescribing information

Detailed Description:

Sequential enrollment

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971893

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00971893     History of Changes
Other Study ID Numbers: B0121003
Study First Received: September 3, 2009
Last Updated: October 29, 2009
Health Authority: India: Ministry of Health

Keywords provided by Pfizer:
Acute Exacerbation of Bronchial Asthma Acute Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on October 01, 2014