Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations

NCT06160713 | Unknown Phase 3 DMC

• 1 other identifier: Study 1291
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

There is an intricate link between bronchiectasis and fungi. Patients with cystic fibrosis frequently manifest fungal sensitization and fungal colonization with Aspergillus fumigatus.6 Aspergillus species also has a cause-and-effect relationship with non-CF (cystic fibrosis) bronchiectasis.7, 8 In allergic bronchopulmonary aspergillosis (ABPA), Aspergillus is the cause of bronchiectasis. In contrast, in other causes of bronchiectasis, A fumigatus can theoretically promote allergic response, which may result in poor lung function, increase the risk of exacerbations, and even cause ABPA over time.9, 10 In a recent study, we found an overall prevalence of Aspergillus sensitization of 29.5% and the prevalence of chronic aspergillus infection was 76%.11 The prevalence of chronic aspergillus colonization in non-(tuberculosis) TB-non-CF fibrosis was 47.5% (49/103).11 By mechanism similar to chronic bacterial colonization, chronic aspergillus infection or aspergillus sensitization can increase the risk of bronchiectasis exacerbation. Therefore, eradication of A. fumigatus from the airways of patients with bronchiectasis would decrease the future risk of a bronchiectasis exacerbation. Notably, in ABPA, use of itraconazole and voriconazole reduce the exacerbations by reducing the fungal burden in the airways.12, 13 In this randomized trial, we will investigate whether treatment with oral itraconazole for six months would reduce the future risk of bronchiectasis exacerbation in patients with non-CF-non-ABPA bronchiectasis.

Conditions

Bronchiectasis; Bronchiectasis Adult

Outcome Measures

Primary Outcomes (1)

• frequency of bronchiectasis exacerbations during the study period

  An exacerbation will be defined as clinical deterioration for at least 48 hours and the presence of three or more of the following six features: (1) increase in cough; (2) sputum volume/consistency; (3) sputum purulence; (4) breathlessness or exercise intolerance; (5) fatigue, malaise, or fever; (6) hemoptysis; and change of bronchiectasis treatment by a physician

  (12 months [6 months each of intervention and observation])

Secondary Outcomes (6)

• time to first exacerbation

  12 months

• change in the spirometric lung function (FVC)

  12 months

• change in the spirometric lung function ( FEV1)

  12 months

• Change in 6 minute walk distance

  6 months

• Adverse events

  6 months

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Standard care of bronchiectasis

Other: Standard care

Itraconazole arm

EXPERIMENTAL

Supra-bioavailable- Itraconazole capsule 65 mg

Drug: Itraconazole 65 MG; Other: Standard care

Interventions

Itraconazole 65 MG DRUG

Two capsules of suba-itraconazole 65 mg twice daily for 6 months

Itraconazole arm

Standard care OTHER

Standard care for bronchiectasis

Itraconazole arm; Standard care

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic aspergillus infection defined by the presence of A.fumigatus-specific IgG ≥40 mgA/L

You may not qualify if:

• We will exclude subjects with any of the following:
• allergic bronchopulmonary aspergillosis as the cause of underlying bronchiectasis
• cystic fibrosis
• post-tuberculosis bronchiectasis
• severe asthma
• current smokers
• active bacterial, mycobacterial (atypical or typical), or fungal (aspergillosis or mucormycosis) infections
• use of systemic antifungal drugs in past 3 months
• previous documented intolerance to itraconazole
• pregnancy
• failure to provide informed consent

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Chest clinic

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Interventions

Itraconazole; Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized trial

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

IN (1)