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NCT03133299

A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma

Completed Phase 2, PHASE3 Last updated 23 August 2018
What this trial tests

Phase 2, PHASE3 trial testing Glucocorticoids in Allergic Bronchopulmonary Aspergilloses in 30 participants. Completed in 30 June 2018.

Timeline
1 December 2016
Primary endpoint
30 June 2018
30 June 2018

Quick facts

Lead sponsorPost Graduate Institute of Medical Education and Research, Chandigarh
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 December 2016
Primary completion30 June 2018
Estimated completion30 June 2018
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Who can join

Adults 18 to 65, any sex, with Allergic Bronchopulmonary Aspergilloses. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Allergic bronchopulmonary aspergillosis (ABPA) is a immunological pulmonary disorder caused by hypersensitive reaction to spores of Aspergillus fumigatus. The prevalence of disease is about 1-2% in asthmatics and 2-15% in patients with cystic fibrosis. The interest in ABPA stems from the fact that the disease is glucocorticoid-sensitive and early treatment can prevent progression to end-stage lung disease. Recently anti-Th2 therapies have been suggested as treatment for ABPA. Vitamin D has been shown to suppress the Th2 responses and decrease the levels of Th2 interleukins. Hence, the investigators propose to assess the role of vitamin D in treating ABPA.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A randomised trial of vitamin D in acute-stage allergic bronchopulmonary aspergillosis complicating asthma.
    Dodamani MH, Muthu V, Thakur R, Pal A, et al · · 2019 · cited 22× · PMID 30561849 · DOI 10.1111/myc.12879

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Other trials of Glucocorticoids

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