Could a nitric oxide mist fight tough lung infections?
NCT ID NCT06663176
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new inhaled nitric oxide treatment (RESP30X) in 60 adults with non-cystic fibrosis bronchiectasis who have stubborn lung infections like Pseudomonas. The main goals are to check safety and how well the body tolerates the mist, while also seeing if it can reduce bacteria in the lungs. Participants will receive the treatment and be monitored for side effects and changes in infection levels.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Provide written, informed consent prior to all study-related procedures and agree to undergo all study procedures. * Aged between 18 and 75 years, inclusive. * Clinical history of bronchiectasis affecting 1 or more lobes based on symptoms (cough, sputum productive and/or recurrent lower respiratory tract infections) as confirmed by historical CT scan and radiology report performed within the last 5 years. * Confirmed high-titre respiratory PPMs (Part 1: Pa only) at screening ≥10\^5 CFU/mL (as determined by central laboratory microbiological cultures). * Individuals of childbearing potential must agree to use protocol defined method(s) of contraception during the study and for at least 90-days after the last dose of IMP. * Patients who can produce spontaneous sputum on a daily basis. * Patients who are able to self-administer the SABA inhaler and study nebuliser for IMP administration effectively in the Investigator's opinion, following training. * Patients appropriately vaccinated against influenza and pneumococcus at least 14-days prior to Day 1. Exclusion Criteria: * Currently receiving therapy with any inhaled antibiotic therapy. Patients who have previously received inhaled antibiotic therapy may be eligible if therapy was discontinued at least 28-days prior to screening. * Treatment with systemic anti-infective therapy within 28-days prior to screening. * Participation in other clinical studies with investigational agents within 8 weeks prior to screening. * Treatment with NO and other NO donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening. * Treatment with immunosuppressive medications within 2 weeks prior to screening, or systemic corticosteroids, or immunoglobulin therapy for more than 7 days within 2 weeks prior to screening. * HIV positive AND CD4 \< 350 cells/mm3 * FEV1 \<55% predicted at the screening visit. * Significant haemoptysis within 60 days of screening defined as an estimated volume of 50ml at any time. * History of methaemoglobinaemia. * Taking medications that may induce methaemoglobinaemia, or have received these within 30 days of screening. * Baseline SpMet \>5%. * Current smokers of tobacco products, marijuana, e-cigarettes/vaping: a current smoker is defined as having inhaled any of these within 3 months of screening. * In the opinion of the investigator, patients with an acute exacerbation of NCFB. * In the opinion of the investigator, any other clinically relevant active respiratory disease with the potential to compromise participant safety or confound interpretation of safety or efficacy outcomes. Patients who have experienced \>2 exacerbations of asthma or COPD requiring treatment with systemic corticosteroids within the past 12 months are not eligible. * Asthma which requires treatment with GINA steps 4-5 suggested medications i.e., high dose ICS and LABA or leukotriene modifier/theophylline for the previous year, or systemic corticosteroids for ≥50% of the previous year to prevent it from becoming "uncontrolled", or which remains "uncontrolled" despite this therapy. * Patients with a diagnosis of primary ciliary dyskinesia. * Patients with a diagnosis of pulmonary hypertension. * Patients with a current diagnosis of TB based on clinical testing or symptoms. Patients with a history of TB who have completed a course or eradication therapy at least 2 years prior to screening may be eligible if there is no clinical suspicion of recurrence. Patients with latent TB are eligible provided they have received adequate treatment per local country guidelines. * Patients with a diagnosis, or suspected diagnosis, of NTM infection according to the ATS/IDSA statement on diagnosis, treatment, and prevention of non-tuberculous mycobacterial diseases. Patients with a previous positive culture that is suspected to be a contaminant are eligible. * Symptomatic GERD causing NCFB disease. * Conditions of increased risk for MetHb formation, significant anaemia or haemoglobinopathy. * Known allergy to active substance or any excipients, or to auxiliary product. * Known hypersensitivity to NO. * History of anaphylaxis to any medication or hospitalisation due to an adverse drug reaction (ADR). * Patients who are pregnant or breastfeeding. * Patients planning to conceive a child within the anticipated period of study participation and for at least 90-days after the last dose of IMP in the study. * Patients unable or unwilling to comply with the protocol or to cooperate fully with the investigator or site personnel. * Alcohol or drug abuse, that in the opinion of the investigator, is sufficient to compromise the safety or cooperation of the participant. * Patients with the following toxicities at screening as defined by the enhanced CTCAE toxicity table version 5.0, 27Nov2017. 1. creatinine \>1.5 times upper limit of normal (ULN) 2. haemoglobin ≤8.0 g/dL 3. platelets \<50x10\^9 cells/L 4. serum potassium \<3.5 mmol/L 5. aspartate aminotransferase (AST) \>3 x ULN 6. alanine aminotransferase (ALT) \>3 x ULN 7. alkaline phosphatase (ALP) ≥ 2.5 x ULN 8. total bilirubin \>1.5 x ULN 9. total white cell count \<2 cells x 10\^9/L. * QTcF \>450 milliseconds (males) or 470 milliseconds (females) or history of congenital long QT syndrome, Torsades de Pointes or other clinically significant abnormal ECG at screening or baseline. * History of solid organ transplantation. * History of malignancy or treatment for malignancy within the past year.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ARENSIA Exploratory Medicine
Kyiv, Ukraine
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Other studies related to the condition(s) this trial covers.
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