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The present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients.
Sequential enrollment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Methylprednisolone Tablets | Drug | Oral Methylprednisolone tablets given as per locally approved prescribing information |
|
| Measure | Description | 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) | 10 days after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of Acute Asthma who have been prescribed oral Medrol tablets, will be enrolled
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| 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 |
| 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 |
| Physician-directed intensification of pharmacologic therapy between discharge from hospital and first follow up visit. | 8 - 22 days after discharge |
| Summary of adverse events in the study | Baseline to 20 days after discharge |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |