Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07362667

A Study of the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With ABPA

To evaluate the efficacy and safety of bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China

Jinan, Shandong, 250014, China

Location status: Recruiting

Location contact

Qian Qi, Dr.

CONTACT

[email protected]

+86 13706380314

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnostic criteria of allergic bronchopulmonary aspergillosis, according to the ISHAM guidelines for the diagnosis and treatment of allergic bronchopulmonary aspergillosis (2024 revision), and the presence of mucus plugs or hyperattenuated mucus confirmed by chest high-resolution CT (HRCT).
  • Active disease: Newly diagnosed allergic bronchopulmonary aspergillosis or an acute exacerbation after discontinuation of treatment (defined as a > 14 day history of clinical worsening or radiographic progression of allergic bronchopulmonary aspergillosis and a ≥50% increase in total serum IgE from the last recorded value during the stable phase, excluding other causes of the acute exacerbation) in patients with previously diagnosed allergic bronchopulmonary aspergillosis.
  • Age ≥ 18 years old.

Exclusion criteria

  • Allergic bronchopulmonary aspergillosis - serotype (i.e., meets the diagnostic criteria for allergic bronchopulmonary aspergillosis, but chest CT shows no obvious abnormality);
  • Patients with absolute or relative contraindications to electronic bronchoscopy;
  • Known history of allergy to amphotericin B or any of its excipients;
  • Patients with bronchiectasis caused by human immunodeficiency virus infection, active tuberculosis, pulmonary malignant tumor or other non-allergic bronchopulmonary aspergillosis;
  • Combined with other diseases requiring long-term systemic use of glucocorticoids or immunosuppressants (such as autoimmune diseases);
  • Patients with previous or current smoking history;
  • Pregnant or lactating women;
  • Currently participating in other interventional clinical research;
  • Any other conditions considered by the investigator to preclude participation in the study (e.g., nonadherence, predicted survival <1 year, or severe mental illness that prevented cooperation).

Treatment and study plan

The patients were treated with bronchoscopic airway clearance and amphotericin B spraying

Procedure

In addition to standard medical therapy (oral glucocorticoids with or without oral antifungal agents), bronchoscopic airway clearance and bronchoscopic spraying of amphotericin B (depending on the effectiveness of bronchoscopic mucus plug removal, At least one time of bronchoscopic airway clearance and amphotericin B spraying). The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc.

Primary outcomes

  1. Radiographic response rate after 4 months of treatment

    Time frame: 4 months

    Radiographic remission: defined as the removal of mucus plugs in the airway on radiographic examination

  2. Immunological remission rate after 4 months of treatment

    Time frame: 4 months

    Immunological remission: defined as at least a 50% decrease in total serum IgE from baseline

  3. The remission rate of clinical symptoms after 4 months of treatment

    Time frame: 4 months

    Clinical symptom relief: The semi-quantitative rating of clinical symptoms was evaluated using Likert scores with at least 50% improvement in symptoms

Secondary outcomes

  1. Number of acute exacerbations within 1 year of drug withdrawal after 4 months of treatment

    Time frame: 1 year

  2. Number of acute exacerbations within 2 years after 4 months of treatment

    Time frame: 2 years

  3. Treatment response rate at 8 weeks

    Time frame: 8 weeks

  4. Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis

    Time frame: 2 years

  5. Time from discontinuation to first exacerbation

    Time frame: 2 years

  6. After drug withdrawal, the number of patients who achieved treatment remission

    Time frame: 2 years

    The remission phase was defined as sustained (>6 months) clinical-radiologic improvement in the absence of (or discontinuation of) glucocorticoid therapy and the absence of an increase in total serum IgE of 50% or more from the last recorded value during the stable phase

  7. Quality of life score (AQLQ or mini-AQLQ)

    Time frame: 2 years

  8. Serum total IgE

    Time frame: 2 years

  9. All-cause mortality

    Time frame: 2 years

  10. psychological Scale (Hospital Anxiety and Depression Scale, HADS)

    Time frame: 2 years

  11. Aspergillus fumigatus sIgE

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Qi, Dr.

CONTACT

[email protected]

+86 13706380314

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With Allergic Bronchopulmonary Aspergillosis

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.