Effects of integrated environmental intervention on prevention of worsening of allergic bronchopulmonary aspergillosis

Not Applicable

Recruiting

• Conditions: Allergic bronchopulmonary aspergillosis

• Registration Number: JPRN-UMIN000048857
• Lead Sponsor: Japan Agency for Medical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-11
• Last Update Posted: 17 October 2023
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with Aspergillus-related lung disease other than ABPM (chronic pulmonary aspergillosis, etc.) 2. Patients with with cystic fibrosis 3. Those who plan to move from their current residence within one year of the scheduled start date of the research 4. Persons whose current residence is less than 1 year old from the scheduled start date of research 5. Those who do not have an air conditioner installed in the living room or the bedroom in their current residence. 6. The air conditioner in the living room and the bedroom in the current residence has been purchased or cleaned by a professional within one year of the scheduled start date of research. 7. Complete remission in the past 3 years; no treatment with oral steroids, antifungal drugs, or antibody drugs, no clinical symptoms or no abnormalities in the laboratory and radiographic tests 8. Patients who have received medium to high-dose oral steroid therapy (more than 10 mg/day equivalent to PSL for 14 days or more) within the past month 9. Patients who have newly started antifungal drug or biologics within the past 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parallel-group comparative study: comparison of maximum total serum IgE levels in the first year after intervention in the control environmental intervention group and the integrated environmental intervention group Before-and-after study: comparison of maximum serum total IgE levels in the first year after intervention with control and integrated environmental interventions

Secondary Outcome Measures

Name	Time	Method
Comparison of maximum serum Aspergillus-specific IgE antibody titers in the first year after intervention Rate of change in serum total IgE level and serum Aspergillus-specific IgE antibody level beforeand after 1 year of intervention Changes in serum Aspergillus-specific IgG antibody titers before and after intervention Change in ABPM relapse rate before and after intervention Change in asthma exacerbation rate before and after intervention Changes in room temperature and humidity before and after intervention Changes in indoor fungal load before and after intervention Changes in mite antigen content in house dust before and after intervention (exploratory outcomes) Changes in peripheral blood eosinophil counts Changes in serum titers of IgE antibody to fungi other than Aspergillus Changes in FeNO Changes in miniAQLQ, ACQ5, CAT Changes in radiographic findings in chest Changes in VOC in residences Changes in fungal species in residences Changes in bacterial load and species in residences