ClinicalTrials.gov record NCT06989333

Local Spraying of GM-CSF Via Bronchoscopy in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

A Single-arm Clinical Study of Local Spraying of GM-CSF Via Bronchoscopy in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
AgeSee eligibility The registry's age field and its own written criteria give different ages for this study. Check the full criteria below and ask the study team.
SexAll
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This single-arm Phase 2 study investigates delivering recombinant GM-CSF directly into the airways by bronchoscopy in people with autoimmune pulmonary alveolar proteinosis (aPAP). It will assess feasibility and safety and look for early signs of effect, with chest high-resolution CT (HRCT) at 12 weeks as the primary measure. The drug is dissolved in saline and sprayed into affected lung segments during bronchoscopy performed under general anesthesia or sedation.

What it is studying. Whether directly spraying GM‑CSF into diseased lung segments via bronchoscopy is feasible, safe, and shows preliminary clinical or imaging effects in people with autoimmune pulmonary alveolar proteinosis, using chest HRCT at 12 weeks as a key measure.

What the researchers hope to learn. To gather data on feasibility and safety of bronchoscopic GM‑CSF delivery in aPAP and to collect preliminary evidence of effect on lung imaging at 12 weeks.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This study aims to explore a new therapeutic approach: the feasibility, safety and preliminary efficacy of directly spraying GM-CSF into the airway through bronchoscopy for the treatment of aPAP.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • GM-CSF (granulocyte-macrophage colony-stimulating factor)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Age: 18 to 60 years old;
  • A clear diagnosis of aPAP must meet at least one of the following diagnostic criteria:
  • BALF appears "milky white"; Or cytological examination reveals a large amount of PAS-positive protein deposition; 2) HRCT shows typical "paving stone-like changes"; 3) Positive for serum GM-CSF antibody. 3. There are more than one of the following treatment indications: Symptoms such as progressive breathing difficulties, coughing, and shortness of breath after activity occur; 2) Without oxygen inhalation, PaO2 > 65 mmHg 3) Pulmonary function DLCO accounts for % of the predicted value, ranging from 60% to 80%, including the critical value.
  • No other PAP specific treatments (such as WLL, inhaled GM-CSF, biological agents, etc.) have been received recently (for more than 4 weeks).
  • Agree to participate in this study and sign the informed consent form.

Exclusion criteria

  • Secondary PAP (such as secondary to blood diseases, etc.);
  • Patients with obvious pulmonary fibrosis, emphysema or irreversible lung function impairment;
  • Patients in the acute exacerbation stage;
  • Patients with other lung diseases (such as active pulmonary tuberculosis, bronchiectasis with purulent infection or other chronic infections; Have severe asthma, chronic bronchospasm, etc.
  • Have a history of allergy to GM-CSF antibodies or related drug components;
  • Patients who have participated in other clinical drug trials within the past three months;
  • Patients who have experienced severe complications related to bronchoscopy or are intolerant to bronchoscopy;
  • Concurrent with other serious cardiovascular and cerebrovascular diseases, hematological disorders, malignant tumors, etc.
  • Pregnant or lactating women.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After giving informed consent, participants will have bronchoscopy under general anesthesia or sedation. During bronchoscopy, a predetermined dose of recombinant GM‑CSF dissolved in saline will be sprayed into the identified diseased lung segments. The study's main measurement listed in the record is a chest high-resolution CT (HRCT) at 12 weeks. The registry does not specify other visit schedules or assessments in detail.

How the study is structured. Interventional, Phase 2, single-group (all participants receive the same treatment), non-masked study. Participants undergo bronchoscopy under anesthesia or sedation; recombinant GM‑CSF dissolved in saline is sprayed into identified diseased lung segments. Outcomes include imaging (chest HRCT) evaluated at 12 weeks.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • No sites are listed on the registry yet. Where will the study take place?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on pulmonary alveolar proteinosis

Clinical trials5 trials listed for pulmonary alveolar proteinosisEvery trial the registry lists for pulmonary alveolar proteinosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in pulmonary alveolar proteinosis researchLatest monthly update: September 2026. Includes: ECMO during lavage. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 1, 2025 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Study completion
Jun 30, 2027 (estimated)
Target enrollment
10 participants (estimated)
Last updated on registry
May 25, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Jiuwu Bai

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

HRCT
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
DLCO
A breathing test that measures how well the lungs pass oxygen from the air into the blood.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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