Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation
Conditions
Interventions
Intervention1: Prednisolone: Group 1: 48 hours after admission, participants (patients with cystic fibrosis with pulmonary exacerbation) will receive oral prednisolone at a dose of 1mg/kg day in two
Sponsors
Post Graduate Institute of Medical Education and Research Chandigardh
Eligibility
Inclusion criteria
Inclusion criteria: 1)Confirmed diagnosis of cystic fibrosis based on: Newborn screening or at least one clinical feature of CF, AND either (a) or (b) as follows: a) Documented sweat chloride = 60 mEq/L by quantitative pilocarpine iontophoresis b)Genotype with two identifiable CF-causing mutations. 2)Age > 6 years old. 3)Acute pulmonary exacerbation as per Fuchs criteria
Exclusion criteria
Exclusion criteria: 1)Active allergic bronchopulmonary aspergillosis (ABPA) at the time of enrollment as determined by the treating physician. 2)Uncontrolled hypertension with suspected end organ damage 3)Physical findings that could potentially compromise the safety of the participant or the quality of the study data as determined by site investigator. 4)Children enrolled in the study within the preceding twelve months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical outcome variables will be a ) Change in FEV1 from day 1 of admission, to day 14 of admission, and at 12 weeks. b ) The proportion of participants who achieve >90% of their baseline FEV1 % in 12 weeks. c ) Time to subsequent pulmonary exacerbation within 1 year follow up time d ) Number of exacerbations within one year. Timepoint: The time period will be different for each participant | — |
Secondary
| Measure | Time frame |
|---|---|
| 1a) Number of adverse events per participant during hospitalization. 1b) Number of participants with any adverse event 1c) Number of participants with hypertension at 1 and 3 months follow-up 1d) Number of participants with abnormal blood sugar and/or HbA1c at 1 and 3 months follow-up 1e) Number of participants with cataract at 3 and 12 months follow-up. 2a) Proportion of children with change in sputum/throat swab microbiology in form of eradication of organism on day 1 and day 12. 2b ) Proportion of children with change in sputum/throat swab microbiology in form of decrease or increase in colony count. 2c ) Proportion of children with decrease in serum inflammatory markers at day 1 and day 14. 3a) Proportion of children with decrease in CF related symptoms, assessed by CF symptom questionnaire on day 14 and at 12 week compared to day 1. 4a ) Mean duration of hospital stay.Timepoint: Time point will be different for each participant | — |
Countries
India
Contacts
Public ContactJoseph L Mathew
Post Graduate Institute of Medical Education and Research Chandigardh
Outcome results
None listed