Non-Cystic Fibrosis BronchiectasisPhase 1/2NOPANCT06663176
Nebulised RESP30X Nitric Oxide Formulations in NCFB Patients With Pseudomonas Aeruginosa (Pa)
A Phase 1/2 study testing RESP302 and RESP303 in people with Non-Cystic Fibrosis Bronchiectasis, run by Thirty Respiratory Limited at 1 site in Ukraine.
Trial summary
A Phase 1/2a, Multi-Centre, Randomised, Open-label study to assess the safety, tolerability, PK, and efficacy of RESP30X in Adult NCFB participants with confirmed high-titre respiratory PPMs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Cystic Fibrosis Bronchiectasis
- What is being tested?
- RESP302 and RESP303
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUkraine
- Study dates
- 16 Oct 2024to 5 May 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
- creatinine >1.5 times upper limit of normal (ULN)
- haemoglobin ≤8.0 g/dL
- platelets <50x10^9 cells/L
- serum potassium <3.5 mmol/L
- aspartate aminotransferase (AST) >3 x ULN
- alanine aminotransferase (ALT) >3 x ULN
- alkaline phosphatase (ALP) ≥ 2.5 x ULN
- total bilirubin >1.5 x ULN
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1/2a Trial to Evaluate the Safety, Tolerability and Efficacy of Nebulised RESP30X Nitric Oxide Formulations in Non-Cystic Fibrosis Bronchiectasis (NCFB) Patients With Pseudomonas Aeruginosa (Pa) or Other Potentially Pathogenic Micro-organisms (PPMs)
A Phase 1/2a, Multi-Centre, Randomised, Open-label study to assess the safety, tolerability, PK, and efficacy of RESP30X in Adult NCFB participants with confirmed high-titre respiratory PPMs.
Read the detailed description
A total of approximately 60 participants will be enrolled in this study, to give 30 participants completing the study.
Part 1: Approximately 12 NCFB patients with confirmed high-titre Pa (≥10^5 CFU/mL) to be enrolled to give 6 participants completing the study.
Participants will receive treatment with nebulised RESP303 in a Single Ascending Dose (SAD) phase followed by RESP303 three times a day (TID) multiple daily dosing for 28-days.
A safety review committee will meet after 6 participants have completed the study to determine whether Part 2 of the study can be initiated.
Part 2: Approximately 48 NCFB patients with confirmed high-titre respiratory PPMs (≥10^5 CFU/mL) to be enrolled to give 24 participants completing the study.
Participants will be randomised to receive treatment with nebulised RESP302 in a SAD phase, followed by RESP302 TID multiple daily dosing for 28-days, or nebulised RESP303 in a SAD phase, followed by either RESP303 twice a day (BID) or RESP303 TID multiple daily dosing for 28-days (1:1:1).
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Being tested
- RESP302, RESP303
- Keywords
- Nitric Oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESP302Drug
Nitric Oxide agent
RESP303Drug
Nitric Oxide agent
| Study group | Role | What they receive |
|---|---|---|
| Part 1-1 (Active) | Experimental | RESP303 Single Ascending Dose Phase followed by Multiple Daily Dosing (28-days) Receives: Drug: RESP303 |
| Part 2-1 (Active) | Experimental | RESP302 TID Single Ascending Dose Phase followed by Multiple Daily Dosing (28-days) Receives: Drug: RESP302 |
| Part 2-2 (Active) | Experimental | RESP303 BID Single Ascending Dose Phase followed by Multiple Daily Dosing (28-days) Receives: Drug: RESP303 |
| Part 2-3 (Active) | Experimental | RESP303 TID Single Ascending Dose Phase followed by Multiple Daily Dosing (28-days) Receives: Drug: RESP303 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, intensity, causality, and seriousness of treatment-emergent adverse events (TEAEs).
A TEAE is defined as any event not present before exposure to the study treatment or any event already present that worsens in either intensity or frequency after exposure to the study treatment.
The medical assessment of severity is determined per the CTCAE Toxicity Table Version 5 dated 27 November 2017. (Grade 1-Mild, Grade 2-Moderate, Grade 3-Severe, Grade 4 -Potentially Life threatening, Grade 5-Death)
The relationship or association of the study treatment in causing or contributing to the AE will be characterised using the classification and criteria based on Adverse Events Attribution/Casualty Ratings Relatedness Rating table. (Not Related, Unlikely, Possible, Probable, Certain)
Measured: 58 days
Changes in clinical laboratory values (haematology, clinical chemistry) at each time point.
The following haematological tests will be performed: haemoglobin, MetHb (local laboratory only), haematocrit, mean cell haemoglobin, mean cell volume, red blood cell count, white blood cell count with differentials (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), reticulocyte count, platelet count and rheumatoid factor (Day 1 only).
The following serum chemistry tests will be performed: albumin, blood urea nitrogen,creatinine, direct, indirect, and total bilirubin, total protein, ALP, AST, ALT, gamma-glutamyl transferase, creatinine, creatine kinase, lactate dehydrogenase, total cholesterol, calcium, sodium, potassium, chloride glucose and follicle stimulating hormone (FSH) (as required).
Measured: 58 days
Changes in vital signs (blood pressure, heart rate, temperature, respiratory rate) and SpO2 at each time point.
Vital signs include systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg),heart rate (beats per minute (BPM)), respiratory rate (breaths per minute), SpO2 (%) and body temperature (axillary). On days where there is IMP dosing, vital signs should be performed prior to SABA inhaler administration and before blood draws are taken for safety assessments
Measured: 58 days
Secondary outcomes (7)
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Plasma PK parameter - Cmax
Measured: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Plasma PK parameter - Tmax
Measured: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Plasma PK parameter - AUC0-t,
Measured: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
AUC0-tau
Measured: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Plasma PK parameter - AUC0-inf
Measured: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Plasma PK parameter - Ctrough
Measured: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Plasma PK parameter - t1/2
Measured: 58 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start16 Oct 2024
- Primary completion5 Feb 2028 (estimated)
- Study completion5 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Single Ascending Dose, Multiple Daily Dosing
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thirty Respiratory Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663176
- Sponsor's protocol ID
- RESP30X-001
- Acronym
- NOPA
- Status last verified
- Mar 2026
- First submitted
- 25 Oct 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Thirty Respiratory confirm that within one year of the end of the trial a summary of data will be uploaded to ClinTrials.gov, and all required data will be available in CTIS within the deadlines specified in relevant EU legislation. This data will remain available until the product is withdrawn from the market. This data will include but is not limited to protocol summary, safety and efficacy data related to the use of the product under the conditions of the clinical trial and which adds to the scientific understanding of the product or class of products. Patient data will be anonymised.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a Trial to Evaluate the Safety, Tolerability and Efficacy of Nebulised RESP30X Nitric Oxide Formulations in Non-Cystic Fibrosis Bronchiectasis (NCFB) Patients With Pseudomonas Aeruginosa (Pa) or Other Potentially Pathogenic Micro-organisms (PPMs)
- ClinicalTrials.gov ID
- NCT06663176
- Acronym / sponsor ID
- NOPA / RESP30X-001
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Keywords
- Nitric Oxide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Thirty Respiratory LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 5 Feb 2028 (estimated)
- Study completion
- 5 May 2028 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1/2a, Multi-Centre, Randomised, Open-label study to assess the safety, tolerability, PK, and efficacy of RESP30X in Adult NCFB participants with confirmed high-titre respiratory PPMs.
Detailed description
A total of approximately 60 participants will be enrolled in this study, to give 30 participants completing the study.
Part 1: Approximately 12 NCFB patients with confirmed high-titre Pa (≥10^5 CFU/mL) to be enrolled to give 6 participants completing the study.
Participants will receive treatment with nebulised RESP303 in a Single Ascending Dose (SAD) phase followed by RESP303 three times a day (TID) multiple daily dosing for 28-days.
A safety review committee will meet after 6 participants have completed the study to determine whether Part 2 of the study can be initiated.
Part 2: Approximately 48 NCFB patients with confirmed high-titre respiratory PPMs (≥10^5 CFU/mL) to be enrolled to give 24 participants completing the study.
Participants will be randomised to receive treatment with nebulised RESP302 in a SAD phase, followed by RESP302 TID multiple daily dosing for 28-days, or nebulised RESP303 in a SAD phase, followed by either RESP303 twice a day (BID) or RESP303 TID multiple daily dosing for 28-days (1:1:1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Single Ascending Dose, Multiple Daily Dosing
| Arm | Type | Receives |
|---|---|---|
| Part 1-1 (Active) | Experimental | Drug: RESP303RESP303 Single Ascending Dose Phase followed by Multiple Daily Dosing (28-days) |
| Part 2-1 (Active) | Experimental | Drug: RESP302RESP302 TID Single Ascending Dose Phase followed by Multiple Daily Dosing (28-days) |
| Part 2-2 (Active) | Experimental | Drug: RESP303RESP303 BID Single Ascending Dose Phase followed by Multiple Daily Dosing (28-days) |
| Part 2-3 (Active) | Experimental | Drug: RESP303RESP303 TID Single Ascending Dose Phase followed by Multiple Daily Dosing (28-days) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (41 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESP302Nitric Oxide agent | Drug | Part 2-1 (Active) |
| RESP303Nitric Oxide agent | Drug | Part 1-1 (Active), Part 2-2 (Active), Part 2-3 (Active) |
Primary outcome
Incidence, intensity, causality, and seriousness of treatment-emergent adverse events (TEAEs).
Time frame: 58 days
A TEAE is defined as any event not present before exposure to the study treatment or any event already present that worsens in either intensity or frequency after exposure to the study treatment. The medical assessment of severity is determined per the CTCAE Toxicity Table Version 5 dated 27 November 2017. (Grade 1-Mild, Grade 2-Moderate, Grade 3-Severe, Grade 4 -Potentially Life threatening, Grade 5-Death) The relationship or association of the study treatment in causing or contributing to the AE will be characterised using the classification and criteria based on Adverse Events Attribution/Casualty Ratings Relatedness Rating table. (Not Related, Unlikely, Possible, Probable, Certain)
Changes in clinical laboratory values (haematology, clinical chemistry) at each time point.
Time frame: 58 days
The following haematological tests will be performed: haemoglobin, MetHb (local laboratory only), haematocrit, mean cell haemoglobin, mean cell volume, red blood cell count, white blood cell count with differentials (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), reticulocyte count, platelet count and rheumatoid factor (Day 1 only). The following serum chemistry tests will be performed: albumin, blood urea nitrogen,creatinine, direct, indirect, and total bilirubin, total protein, ALP, AST, ALT, gamma-glutamyl transferase, creatinine, creatine kinase, lactate dehydrogenase, total cholesterol, calcium, sodium, potassium, chloride glucose and follicle stimulating hormone (FSH) (as required).
Changes in vital signs (blood pressure, heart rate, temperature, respiratory rate) and SpO2 at each time point.
Time frame: 58 days
Vital signs include systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg),heart rate (beats per minute (BPM)), respiratory rate (breaths per minute), SpO2 (%) and body temperature (axillary). On days where there is IMP dosing, vital signs should be performed prior to SABA inhaler administration and before blood draws are taken for safety assessments
7 secondary outcomes
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Time frame: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Time frame: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Time frame: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Time frame: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Time frame: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Time frame: 58 days
To characterise the PK of RESP30X in NCFB participants with confirmed high-titre respiratory PPMs.
Time frame: 58 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes. Thirty Respiratory confirm that within one year of the end of the trial a summary of data will be uploaded to ClinTrials.gov, and all required data will be available in CTIS within the deadlines specified in relevant EU legislation. This data will remain available until the product is withdrawn from the market. This data will include but is not limited to protocol summary, safety and efficacy data related to the use of the product under the conditions of the clinical trial and which adds to the scientific understanding of the product or class of products. Patient data will be anonymised.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RESP302 and RESP303 in people with Non-Cystic Fibrosis Bronchiectasis, run by Thirty Respiratory Limited at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, intensity, causality, and seriousness of treatment-emergent adverse events (TEAEs). (time frame: 58 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.