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Trial record 1 of 1 for:    NCT00971893
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A Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian Patients

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ClinicalTrials.gov Identifier: NCT00971893
Recruitment Status : Withdrawn
First Posted : September 4, 2009
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 3, 2009
First Posted Date September 4, 2009
Last Update Posted Date November 29, 2018
Study Start Date October 2009
Estimated Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 3, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00971893 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 3, 2009)
  • Relapse within 20 days of hospital discharge (Relapse is defined as above for Primary Endpoint). [ Time Frame: 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 ]
  • 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 ]
  • Proportion of patients controlled for asthma symptoms in the last 7 days after 10 days of hospital discharge [ Time Frame: 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 ]
  • 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 ]
  • Physician-directed intensification of pharmacologic therapy between discharge from hospital and first follow up visit. [ Time Frame: 8 - 22 days after discharge ]
  • Summary of adverse events in the study [ Time Frame: Baseline to 20 days after discharge ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian Patients
Official Title A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients
Brief Summary The present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients.
Detailed Description Sequential enrollment
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients of Acute Asthma who have been prescribed oral Medrol tablets, will be enrolled
Condition Asthma
Intervention Drug: Oral Methylprednisolone Tablets
Oral Methylprednisolone tablets given as per locally approved prescribing information
Study Groups/Cohorts Methylprednisolone Group
Intervention: Drug: Oral Methylprednisolone Tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: November 27, 2018)
0
Original Estimated Enrollment
 (submitted: September 3, 2009)
100
Estimated Study Completion Date April 2010
Estimated Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00971893
Other Study ID Numbers B0121003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018