Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis

Phase 4

Completed

• Conditions: Chronic Cavitary Pulmonary Aspergillosis
• Interventions: Drug: Itraconazole; Drug: treatment in cavitary pulmonary aspergillosis

• Registration Number: NCT01259336
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis

Detailed Description

The role of itraconazole is still not clear in the treatment of chronic cavitary pulmonary aspergillosis(CCPA). Some studies have shown a beneficial role of itraconazole in reducing hemoptysis. So the present study is aimed at analyzing the role of itraconazole in CCPA.

Study Timeline

• Study Start: 2010-07
• Status Verified: 2010-11
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Last Update Submitted: 2012-02-18
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting ≥ six weeks. 2. Radiological findings:

   • Evidence of slowly progressive pulmonary lesions over weeks-months including cavities with surrounding inflammation.
   • presence of intracavitary mass with a surrounding crescent of air,and presence of pleural thickening in peripheral lesions.
   3. Microbiological/Immunological findings: Positive results in the aspergillus precipitin test, demonstration of aspergillus hyphae in sputum or BAL fluid or cultures of BAL/sputum growing aspergillus species.

2. The diagnosis of CCPA will be made if

   1. Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria.
   2. FNAC from the cavity wall will be considered in atypical cases

Exclusion Criteria

1. Invasive aspergillosis 2. Allergic broncho-pulmonary aspergillosis (ABPA) 3. Active tuberculosis or malignancy 4. Pregnant females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Itraconazole	Itraconazole	Role of itraconazole in CCPA
Itraconazole	treatment in cavitary pulmonary aspergillosis	Role of itraconazole in CCPA
treatment in cavitary pulmonary aspergillosis	treatment in cavitary pulmonary aspergillosis	Patients in this arm are given conservative management with antitussives, brochial artery embolisation.

Primary Outcome Measures

Name	Time	Method
clinical improvement in cough and hemoptysis	6 months	Clinical response- assessed by a decrease in frequency \& intensity of hemoptysis \& cough. Significant clinical response will be considered if there is no recurrence of episodes of moderate-massive hemoptysis. Number of interventions required to control hemoptysis will also be taken as a measure of clinical response

Secondary Outcome Measures

Name	Time	Method
Radiological response of CCPA to itraconazole	6 months	1. Complete response- It is defined as complete disappearance of the aspergilloma.; 2. Partial response- It is defined as 30% decrease in the sum of the longest diameters of all the lesions.; 3. Progressive disease- It is defined as appearance of any new lesions or \>20% increase in the sum of the longest diameters of all measurable lesions.; 4. Stable disease- Shrinkage or growth of CCPA that does not meet any of these criteria

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, Punjab, India