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New treatment option for Asthma
Official title Dose-Ranging Study of LQ036 Single-Domain Antibody Nebulization Solution in Poorly Controlled Asthma
ClinicalTrials.gov ID: NCT07589439
What this study is testing
What is LQ036?
LQ036 is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- What is the goal of this study? The goal of this clinical trial is to find out whether the study drug LQ036 (a nebulized solution taken by inhaling through a nebulizer) works to improve lung function and asthma control in people whose asthma is not well controlled.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 75
You may be able to join if
- Outpatients, aged 12 to 75 years inclusive, male or female, with body mass index (BMI) between 18 and 30 kg/m² inclusive. For participants aged 12 to...
- Diagnosed with bronchial asthma according to the 2025 Global Initiative for Asthma (GINA) guidelines prior to screening, with a documented history of...
- For at least 3 months prior to screening, the participant has used inhaled corticosteroids (ICS) combined with at least one controller medication...
- At screening, pre-bronchodilator FEV₁ is ≥40% and \<80% of the predicted normal value. For participants on low-dose ICS, pre-bronchodilator FEV₁ is...
- At screening, Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5.
You likely can't join if
- Life-threatening asthma, defined as an asthma episode requiring intubation within 1 year prior to screening or during the run-in period, and/or a...
- Experienced a severe asthma exacerbation within 1 month prior to screening.
- History of allergy to biologics, or known hypersensitivity to any component of the investigational product.
- Use of biologics (including but not limited to anti-IgE, anti-IL-5, anti-IL-5 receptor, anti-IL-4/13 receptor, anti-TSLP monoclonal antibodies, etc.)...
- Received intravenous immunoglobulin (IVIG) or allergen-specific immunotherapy (SIT) within 3 months prior to screening.
- Received systemic corticosteroids (excluding topical, ophthalmic, or intranasal corticosteroids), antibiotics, antifungals, antivirals, antiparasitic...
See the full eligibility criteria
Who can join
- Outpatients, aged 12 to 75 years inclusive, male or female, with body mass index (BMI) between 18 and 30 kg/m² inclusive. For participants aged 12 to 17 years, body weight must be ≥30 kg.
- Diagnosed with bronchial asthma according to the 2025 Global Initiative for Asthma (GINA) guidelines prior to screening, with a documented history of asthma for ≥12 months.
- For at least 3 months prior to screening, the participant has used inhaled corticosteroids (ICS) combined with at least one controller medication, and has maintained a stable treatment regimen and dosage for at least 1...
- At screening, pre-bronchodilator FEV₁ is ≥40% and \<80% of the predicted normal value. For participants on low-dose ICS, pre-bronchodilator FEV₁ is ≥40% and \<85% of the predicted normal value.
- At screening, Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5.
- At screening, a positive bronchodilator reversibility test (increase in FEV₁ of ≥12% and an absolute increase of ≥200 mL, 15-30 minutes after inhalation of 400 μg salbutamol). If the reversibility test does not reach...
- At screening, blood eosinophil (EOS) count ≥150 cells/μL or fractional exhaled nitric oxide (FeNO) ≥25 ppb.
- Experienced ≥1 severe exacerbation within the 12 months prior to screening (not required for participants on low-dose ICS).
- Participants fully understand the purpose, nature, methods, and possible adverse reactions of the study, voluntarily agree to participate, and sign the informed consent form before any study procedures begin.
- At randomization, pre-bronchodilator FEV₁ has increased by ≤20% from the screening value, and remains ≥40% and \<80% of the predicted normal value (for participants on low-dose ICS, pre-bronchodilator FEV₁ is ≥40% and...
- At randomization, ACQ-5 score ≥1.5.
- During the run-in period, participant compliance with run-in medication and background medication is ≥80% and ≤120%, compliance with daily diary completion is ≥80%, and there are complete data for at least 4 days within...
What rules you out
- Life-threatening asthma, defined as an asthma episode requiring intubation within 1 year prior to screening or during the run-in period, and/or a history of hypercapnia, respiratory arrest, hypoxic seizures...
- Experienced a severe asthma exacerbation within 1 month prior to screening.
- History of allergy to biologics, or known hypersensitivity to any component of the investigational product.
- Use of biologics (including but not limited to anti-IgE, anti-IL-5, anti-IL-5 receptor, anti-IL-4/13 receptor, anti-TSLP monoclonal antibodies, etc.) and/or systemic immunosuppressants (including but not limited to...
- Received intravenous immunoglobulin (IVIG) or allergen-specific immunotherapy (SIT) within 3 months prior to screening.
- Received systemic corticosteroids (excluding topical, ophthalmic, or intranasal corticosteroids), antibiotics, antifungals, antivirals, antiparasitic drugs, non-selective beta-blockers, or herbal medicines with...
- Received live or attenuated vaccine within 3 months prior to screening, or plan to receive live or attenuated vaccine during the study period.
- Underwent bronchial thermoplasty within 12 months prior to screening.
- Underwent major surgery within 8 weeks prior to screening, or plans to undergo surgery requiring general anesthesia or hospitalization for \>1 day during the study period.
- In the investigator's judgment, presence of respiratory diseases other than asthma, including but not limited to chronic obstructive pulmonary disease (COPD), asthma-COPD overlap syndrome (ACOS), or any other...
- Based on imaging and investigator judgment, presence of active tuberculosis or non-tuberculous mycobacterial infection, untreated latent tuberculosis, or history of incompletely treated tuberculosis.
- Active autoimmune disease or autoimmune disease requiring immunosuppressive therapy, such as rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis...
- Blood EOS \>1500 cells/μL at screening, or other systemic diseases that may cause elevated peripheral blood EOS count (e.g., hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, eosinophilic...
- Known or suspected immunodeficiency, including history of invasive opportunistic infection (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) even if resolved; or presence of...
- Known parasitic infection, or suspected or high-risk parasitic infection in the investigator's judgment.
- Active infection (e.g., upper respiratory tract infection) within 1 month prior to screening or during the run-in period, or acute infection requiring systemic anti-infective therapy.
- History of lymphoproliferative disease or malignancy (participants with basal cell carcinoma, localized squamous cell carcinoma of the skin, or cervical carcinoma in situ are eligible if they have completed curative...
- Presence of any other severe and/or uncontrolled disease or treatment that, in the investigator's judgment, may affect the evaluation of the drug, including but not limited to: severe neurological disease, severe mental...
- Current smoker or cessation of smoking for \<6 months; or former smoker with a smoking history of ≥10 pack-years (pack-years = [cigarettes per day / 20] × years of smoking).
- Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening (participants with positive HBsAg but...
- Participants with severe liver or kidney dysfunction, such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN), or serum creatinine \>1.5 × ULN.
- Pregnant or breastfeeding women; women planning to become pregnant during the study or within 3 months after the end of the study; fertile women or men who, in the investigator's judgment, cannot use medically accepted...
- Participation in another clinical study of a drug or device within 3 months prior to signing informed consent, with use of investigational drug/device; or still within the follow-up period of another clinical study or...
- History of blood donation or significant blood loss, blood transfusion, or use of blood products within 3 months prior to screening.
- Known or suspected non-compliance, drug abuse, substance abuse, or alcohol abuse (daily pure alcohol intake \>40 g for males, \>20 g for females).
- Any condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.