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

Effects of integrated environmental intervention on prevention of worsening of allergic bronchopulmonary aspergillosis - ENVIPAS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048857
Enrollment
130
Registered
2022-09-11
Start date
2022-09-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic bronchopulmonary aspergillosis

Interventions

Integrated environmental intervention group 1. Room cleaning by professional cleaners 2. Cleaning guidance by a professional cleaning company 3. Air conditioner cleaning by professional cleaners 4

Sponsors

Japan Agency for Medical Research and Development
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Those who meet 5 points or more in the diagnostic criteria for allergic bronchopulmonary mycosis (2019, J Allergy Clin Immunol. 2021;147:1261) 2. Subjects with a total serum IgE level of 417 IU/mL or higher or an Aspergillus-specific IgE level of 1.0 UA/mL or higher 3. Subjects who have provided have obtained written consent of their own free will.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactKoichiro Asano

Tokai University School of Medicine Division of Pulmonary Medicine, Department of Medicine

ko-asano@tokai-u.jp0463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026