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Trial record 16 of 58 for:    "Aspergillosis" | "Cytochrome P-450 CYP3A Inhibitors"

Six Months Versus 12 Months of Oral Itraconazole Therapy for Management of Treatment naïve Subjects With CPA

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ClinicalTrials.gov Identifier: NCT03920527
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Inderpaul singh, Postgraduate Institute of Medical Education and Research

Brief Summary:
The treatment options majorly consist of medical management with at least 6-month long treatment with antifungal drugs - most significantly the azole groups. Itraconazole is the preferred azole for the treatment of CPA. The duration of treatment with oral itraconazole remains uncertain. In a previous study the use of oral itraconazole for 6-months a favorable overall response was seen in 76% of the subjects. Moreover, about 30%-50% of the subjects have disease relapse that requires prolonged therapy. It is likely that a longer duration of itraconazole would have a higher response rate and thus, lower risk of relapse after discontinuation of therapy. In this randomized controlled trial, we compare the clinical outcomes of six months versus twelve months of itraconazole therapy in treatment naïve subjects with chronic pulmonary aspergillosis

Condition or disease Intervention/treatment Phase
Chronic Pulmonary Aspergillosis Drug: Itraconazole 400 mg Phase 3

Detailed Description:

Aspergillus is a saprophytic fungus which is present normally in our surroundings and causes a large number of pulmonary diseases spreading through inhalational route. The spectrum of disease caused by aspergillus spp. is wide with the manifestations of the disease being governed primarily by the status of the underlying host immunity, which then determines the nature of the host-aspergillus interaction. Patients with an intact immunity have a more stable and indolent form of disease like aspergilloma whereas with a worsening immune status, the risk of invasive disease increases. Chronic pulmonary aspergillosis (CPA) and allergic bronchopulmonary aspergillosis (ABPA) are two of the commonest pulmonary manifestations seen in non-immunocompromised patients whereas invasive pulmonary aspergillosis being more common in the immunocompromised patients.

Estimates suggest that CPA affects around 3 million people across the globe, which may still be an under estimated number as the disease co exists with other pulmonary co-morbidities which make accurate diagnosis a pitfall. In India the annual incidence of CPA was estimated in 2011 and varied between 27,000-0.17 million cases, with different estimates. Based on the mortality rate for CPA which was estimated to be 15% annually, the 5-year prevalence of CPA was placed at 290,147 cases with 5-year prevalence rate being 24 per 100,000 in the same year. The disease confers significant morbidity and mortality, making it a significant burden for the society as well as the healthcare. Apart from the respiratory symptoms, CPA causes significant constitutional symptoms as well which adds to the misery of the patient. The diagnosis of CPA is based on presence of chronic symptoms, consistent radiology and demonstration of Aspergillus by direct (culture) or indirect (serological) methods. Even though CPA is more of a disease spectrum but overall it is characterized by slowly progressive lung cavitation which may or may not show presence of mycetoma /fungal ball in patients with pre-existing structural lung diseases, even though other patterns have also been identified.

The treatment options majorly consist of medical management with at least 6-month long treatment with antifungal drugs - most significantly the azole groups. Itraconazole is the preferred azole for the treatment of CPA. The duration of treatment with oral itraconazole remains uncertain. In a previous study the use of oral itraconazole for 6-months a favorable overall response was seen in 76% of the subjects. Moreover, about 30%-50% of the subjects have disease relapse that requires prolonged therapy. It is likely that a longer duration of itraconazole would have a higher response rate and thus, lower risk of relapse after discontinuation of therapy. In this randomized controlled trial, we compare the clinical outcomes of six months versus twelve months of itraconazole therapy in treatment naïve subjects with chronic pulmonary aspergillosis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Compare the Clinical Outcomes of Six Months Versus 12 Months of Oral Itraconazole Therapy for Management of Treatment naïve Subjects With Chronic Pulmonary Aspergillosis
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Active Comparator: Six months
Six months of itraconazole
Drug: Itraconazole 400 mg
Duration of itraconazole
Other Name: sporanox

Experimental: 12 months
12-months of itraconazole
Drug: Itraconazole 400 mg
Duration of itraconazole
Other Name: sporanox




Primary Outcome Measures :
  1. Relapse rate [ Time Frame: 1 year after treatment completion ]
    number of relapses at 1 year after completion of therapy


Secondary Outcome Measures :
  1. Response [ Time Frame: at 6 to 12 months ]
    Proportion of subjects with an overall favourable response at the end of oral itraconazole therapy

  2. Adverse events [ Time Frame: 1 year ]
    adverse events due to itraconazole



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: includes presence of all the following:

  • one or more clinical symptoms (persistent cough, recurrent hemoptysis, weight loss, malaise, fever and dyspnea) for ≥3 months
  • slowly progressive or persistent radiological findings (one or more cavities and surrounding fibrosis, infiltrates, consolidation, with or without fungal ball or progressive pleural thickening) on computed tomography (CT) of the thorax
  • immunological (A.fumigatus-specific IgG >27 mgA/L or positive Aspergillus precipitins) or microbiological evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions or serum galactomannan index >0.5 or BALF galactomannan index >1) and,
  • exclusion of other pulmonary disorders with similar presentation.

Exclusion Criteria:

  • failure to provide informed consent
  • patients on immunosuppressive drugs, intake of prednisolone (or equivalent) >10 mg for at least 3 weeks or a diagnosis of human immunodeficiency virus syndrome
  • intake antifungal azoles for >3 weeks in the preceding six months
  • subjects with active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis (MOTT)
  • subjects with others forms of pulmonary aspergillosis (allergic bronchopulmonary aspergillosis, chronic necrotizing aspergillosis and angio-invasive aspergillosis)
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920527


Contacts
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Contact: Inderpaul S Sehgal, MD,DM +91-172275 ext 6823 inderpgi@outlook.com
Contact: Ritesg Agarwal +91-172275 ext 6825 agarwal.ritesh@outlook.in

Locations
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India
Inderpaul Singh Recruiting
Chandigarh, India, 160012
Contact: Inderpaul S Sehgal, MD,DM    +91-172275 ext 6823    inderpgi@outlook.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

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Responsible Party: Inderpaul singh, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03920527     History of Changes
Other Study ID Numbers: NK/4947/Res/986
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inderpaul singh, Postgraduate Institute of Medical Education and Research:
CPA
Aspergillosis
CCPA
CFPA
Additional relevant MeSH terms:
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Aspergillosis
Pulmonary Aspergillosis
Cytochrome P-450 CYP3A Inhibitors
Mycoses
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs