A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Doses in Healthy Volunteers and After Single and Repeated Doses in Subjects With Bronchiectasis
NCT ID: NCT06166056
Last Updated: 2025-07-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1/PHASE2
Total Enrollment
45 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-11-29
Study Completion Date
2026-04-30
Brief Summary
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The aim of this clinical trial is to assess the safety of:
* single doses of the study drug CHF6333 in Healthy Volunteers (HVs) and in subjects with Bronchiectasis (BE) - Part I
* repeated doses of the study drug CHF6333 in subjects with BE - Part II
* single doses of the study drug CHF6333 in Healthy Volunteers (HVs) and in subjects with Bronchiectasis (BE) - Part I
* repeated doses of the study drug CHF6333 in subjects with BE - Part II
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Detailed Description
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Conditions
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Bronchiectasis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Part I: randomised, double-blind, placebo-controlled, single ascending dose, alternating cross-over design in HV and single dose in subjects with BE. Part II: randomised, double-blind, placebo-controlled, repeated-dose, 3-way cross-over design in subjects with BE.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Experimental: CHF6333
CHF6333 active (Part I - SAD): once daily inhaled single dose of CHF6333 at each period (three dose levels for HVs and one dose level for BE subjects).
CHF6333 active (Part II - MD): once daily inhaled multiple dose of CHF6333 for 28 days consecutive days (two dose levels for BE subjects).
Group Type
EXPERIMENTAL
CHF6333
Intervention Type
DRUG
CHF6333 Part I SAD; CHF6333 Part II MD.
Placebo comparator: CHF6333 Placebo
CHF6333 placebo (Part I - SAD): once daily inhaled single dose of placebo matching CHF6333 at each period.
CHF6333 placebo (Part II - MD): once daily inhaled multiple dose of placebo matching CHF6333 for 28 days consecutive days.
Group Type
PLACEBO_COMPARATOR
CHF6333 Placebo
Intervention Type
DRUG
Placebo Part I SAD; Placebo Part II MD.
Interventions
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CHF6333
CHF6333 Part I SAD; CHF6333 Part II MD.
Intervention Type
DRUG
CHF6333 Placebo
Placebo Part I SAD; Placebo Part II MD.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Signed and dated informed consent obtained prior to any study-related procedure;
2. Healthy male or female subject ≥18 and ≤60 years of age at screening;
3. Ability to understand the study procedures and the risks involved, and to be trained to use inhalers correctly and to generate sufficient peak inspiratory flow (PIF) (at least 40 L/min) using the In-Check Dial set as per "GenuAir" inhaler resistance, at screening;
4. Body mass index (BMI) ≥18 and ≤35 kg/m2 at screening;
5. Non-smokers or ex-smokers who smoked \<5 pack-years and stopped smoking \>1 year prior to screening;
6. Good physical and mental status, determined via assessment of medical history and clinical examination, at screening and prior to randomisation;
7. Vital signs within normal limits at screening and prior to randomisation: diastolic blood pressure (DBP) ≥40 and ≤89 mmHg, and systolic blood pressure (SBP) ≥90 and ≤139 mmHg; body temperature \<37.5°C;
8. Triplicate 12-lead electrocardiogram (ECG) considered as normal (40 ≤ heart rate ≤110 bpm, 120 ms ≤ PR ≤210 ms, QRS ≤120 ms, Fridericia corrected QT interval \[QTcF\] ≤450 ms for males and QTcF ≤470 ms for females) at screening and prior to randomisation;
9. Lung function measurements within limits at screening and prior to randomisation: forced expiratory volume in 1 second (FEV1) \>80% predicted and FEV1/forced vital capacity (FVC) ratio \>0.70;
10. Male subjects willing to use a male condom throughout the study if they have women of childbearing potential (WOCBP) partners; male subjects with non-WOCBP partners or who are sterile do not have contraception requirements;
11. Female subjects (if WOCBP) and/or their partners (if fertile) must be willing to use a highly effective birth control method, preferably with low user dependency, throughout the study; female subjects who are non-WOCBP or who have non-fertile partners do not have contraception requirements.
1. Signed and dated informed consent obtained prior to any study-related procedure;
2. Male or female subject ≥18 and ≤80 years of age at screening;
3. Clinical history consistent with BE (cough, chronic sputum production, and/or recurrent respiratory infections) that is confirmed by chest computed tomography (CT) demonstrating BE affecting 1 or more lobes (confirmation may be based on prior chest CT); subjects whose past chest radiographic image records or report are not available will undergo chest CT scan during screening;
4. Post-bronchodilator FEV1 ≥50% of the predicted value at screening;
5. If currently receiving treatment for BE, this treatment should be administered at a stable dose;
6. Subjects in a stable clinical condition with no exacerbation of BE for at least 4 weeks prior to randomisation. A pulmonary exacerbation is defined as a deterioration in three or more of the key symptoms for at least 48 hours (cough, sputum volume and/or consistency, sputum purulence, breathlessness and/or exercise tolerance, fatigue and/or malaise, haemoptysis) AND a clinician-prescribed course of antibiotics;
7. Vital signs within normal limits at screening and prior to randomisation: DBP ≥40 and ≤89 mmHg, and SBP ≥90 and ≤150 mmHg; body temperature \<37.5°C;
8. Ability to understand the study procedures and the risks involved, and the ability to be trained to use the inhalers correctly and to generate sufficient PIF (at least 40 L/min) using the In-Check Dial set as per "GenuAir" inhaler resistance, at screening;
9. Male subjects willing to use a male condom throughout the study if they have WOCBP partners; male subjects with non-WOCBP partners or who are sterile do not have contraception requirements;
10. Female subjects (if WOCBP) and/or their partners (if fertile) must be willing to use a highly effective birth control method, preferably with low user dependency, throughout the study; female subjects who are non-WOCBP or who have non-fertile partners do not have contraception requirements.
4\. Post-bronchodilator FEV1 ≥30% of the predicted value at screening.
11\. Subjects who are regular daily sputum producers and who are able to provide at least one sputum sample at screening and two sputum samples prior to randomisation; 12. Subjects with active NE level in sputum sample at screening, defined by either a positive bacterial culture in a local laboratory (a positive result for any pathogen will be accepted for eligibility) or by a positive reading of the NEATstik® in vitro diagnostic test.
2. Healthy male or female subject ≥18 and ≤60 years of age at screening;
3. Ability to understand the study procedures and the risks involved, and to be trained to use inhalers correctly and to generate sufficient peak inspiratory flow (PIF) (at least 40 L/min) using the In-Check Dial set as per "GenuAir" inhaler resistance, at screening;
4. Body mass index (BMI) ≥18 and ≤35 kg/m2 at screening;
5. Non-smokers or ex-smokers who smoked \<5 pack-years and stopped smoking \>1 year prior to screening;
6. Good physical and mental status, determined via assessment of medical history and clinical examination, at screening and prior to randomisation;
7. Vital signs within normal limits at screening and prior to randomisation: diastolic blood pressure (DBP) ≥40 and ≤89 mmHg, and systolic blood pressure (SBP) ≥90 and ≤139 mmHg; body temperature \<37.5°C;
8. Triplicate 12-lead electrocardiogram (ECG) considered as normal (40 ≤ heart rate ≤110 bpm, 120 ms ≤ PR ≤210 ms, QRS ≤120 ms, Fridericia corrected QT interval \[QTcF\] ≤450 ms for males and QTcF ≤470 ms for females) at screening and prior to randomisation;
9. Lung function measurements within limits at screening and prior to randomisation: forced expiratory volume in 1 second (FEV1) \>80% predicted and FEV1/forced vital capacity (FVC) ratio \>0.70;
10. Male subjects willing to use a male condom throughout the study if they have women of childbearing potential (WOCBP) partners; male subjects with non-WOCBP partners or who are sterile do not have contraception requirements;
11. Female subjects (if WOCBP) and/or their partners (if fertile) must be willing to use a highly effective birth control method, preferably with low user dependency, throughout the study; female subjects who are non-WOCBP or who have non-fertile partners do not have contraception requirements.
1. Signed and dated informed consent obtained prior to any study-related procedure;
2. Male or female subject ≥18 and ≤80 years of age at screening;
3. Clinical history consistent with BE (cough, chronic sputum production, and/or recurrent respiratory infections) that is confirmed by chest computed tomography (CT) demonstrating BE affecting 1 or more lobes (confirmation may be based on prior chest CT); subjects whose past chest radiographic image records or report are not available will undergo chest CT scan during screening;
4. Post-bronchodilator FEV1 ≥50% of the predicted value at screening;
5. If currently receiving treatment for BE, this treatment should be administered at a stable dose;
6. Subjects in a stable clinical condition with no exacerbation of BE for at least 4 weeks prior to randomisation. A pulmonary exacerbation is defined as a deterioration in three or more of the key symptoms for at least 48 hours (cough, sputum volume and/or consistency, sputum purulence, breathlessness and/or exercise tolerance, fatigue and/or malaise, haemoptysis) AND a clinician-prescribed course of antibiotics;
7. Vital signs within normal limits at screening and prior to randomisation: DBP ≥40 and ≤89 mmHg, and SBP ≥90 and ≤150 mmHg; body temperature \<37.5°C;
8. Ability to understand the study procedures and the risks involved, and the ability to be trained to use the inhalers correctly and to generate sufficient PIF (at least 40 L/min) using the In-Check Dial set as per "GenuAir" inhaler resistance, at screening;
9. Male subjects willing to use a male condom throughout the study if they have WOCBP partners; male subjects with non-WOCBP partners or who are sterile do not have contraception requirements;
10. Female subjects (if WOCBP) and/or their partners (if fertile) must be willing to use a highly effective birth control method, preferably with low user dependency, throughout the study; female subjects who are non-WOCBP or who have non-fertile partners do not have contraception requirements.
4\. Post-bronchodilator FEV1 ≥30% of the predicted value at screening.
11\. Subjects who are regular daily sputum producers and who are able to provide at least one sputum sample at screening and two sputum samples prior to randomisation; 12. Subjects with active NE level in sputum sample at screening, defined by either a positive bacterial culture in a local laboratory (a positive result for any pathogen will be accepted for eligibility) or by a positive reading of the NEATstik® in vitro diagnostic test.
Exclusion Criteria
1. Participation in another clinical study where investigational drug was received and the last investigations were performed less than 3 months prior to randomisation;
2. Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, hematologic, metabolic, neurological, or psychiatric disorders that may interfere with successful completion of this protocol, according to the investigator's judgment;
3. Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the subject or the evaluation of the results of the study, according to the investigator's judgment;
4. History of respiratory diseases;
5. Positive human immunodeficiency virus (HIV) 1 or HIV2 serology results at screening;
6. Hepatitis serology results which indicate acute or chronic hepatitis B (HB) or hepatitis C virus (HCV) at screening;
7. Documented coronavirus disease 2019 (COVID-19) diagnosis within 2 weeks prior to screening or prior to randomisation, or associated complications/symptoms, which have not resolved within 2 weeks prior to screening;
8. Blood donation or blood loss (equal or more than 450 mL) less than 2 months prior to screening or prior to randomisation;
9. Abnormal liver enzymes at screening or prior to randomisation (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] or bilirubin: \>1.5× upper limit of normal \[ULN\]);
10. Positive urine test for cotinine at screening or prior to randomisation;
11. Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test at screening or prior to randomisation;
12. Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen at screening or prior to randomisation;
13. Treatment with prohibited concomitant medications or if the subject is expected to take prohibited concomitant medications during the study;
14. Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or prior to randomisation;
15. Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the study;
16. Unsuitable veins for repeated venepuncture;
17. Heavy caffeine drinker;
18. For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive serum human chorionic gonadotropin laboratory test. A serum pregnancy test is to be performed at screening and a urine pregnancy test is to be performed prior to randomisation;
19. Use of any kind of electronic smoking devices within 6 months prior to screening.
1. History of a clinically meaningful unstable or uncontrolled chronic comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering the study drug to the subject;
2. Acute symptomatic respiratory tract infection which constitutes an increase from the subject's baseline, per the investigator's judgment, within 4 weeks prior to randomisation;
3. Abnormal and clinically significant 12-lead ECG at screening or prior to randomisation that results in an active medical problem, which may impact the safety of the subject, per the investigator's judgment. Male subjects with QTcF \>450 ms and female subjects with QTcF \>470 ms cannot be enrolled;
4. Clinically significant abnormal laboratory values at screening that, in the opinion of the investigator, may put the subject at risk by participating in the study, or interfere with the subject's treatment or assessment, or influence the results of the study;
5. Participation in another clinical study, where investigational drug was received less than 30 days or less than 5 half-lives of the previous administered product (whichever is longer) prior to screening; participation in another clinical study is also not allowed between screening and randomisation;
6. Primary diagnosis of asthma, as determined by the investigator;
7. Concomitant diagnosis of cystic fibrosis;
8. Diagnosis of chronic obstructive pulmonary disease (COPD) made by a clinician, with airflow obstruction (post-bronchodilator FEV1/FVC ratio \<0.7) and at least a 10 pack-year smoking history; subjects with documented COPD but without airflow obstruction or smoking history will be permitted;
9. Current smokers; ex-smokers must have stopped for at least 1 year prior to screening (≥6 months for electronic smoking devices);
10. Subjects with an active tuberculous mycobacteria (TM) or non-tuberculous mycobacteria (NTM) infection requiring or receiving antibiotic treatment, an active allergic bronchopulmonary aspergillosis requiring treatment with corticosteroids or anti-fungal therapy, and/or a connective tissue disease (CTD) receiving an immunosuppressive treatment equivalent to \>10 mg prednisolone daily or systemic immunosuppression;
11. Diagnosis of common variable immunodeficiency (CVID) or other immunodeficiencies requiring immunoglobulin treatment, based on subject history;
12. Diagnosis of rheumatoid arthritis;
13. Malignancy that has not been in complete remission for at least 1 year or any untreated localised carcinomas;
14. History of solid organ/haematological transplantation and receiving immunosuppressive therapy;
15. Use of any antimicrobials (oral, inhaled, or intravenous) within 4 weeks prior to randomisation, except for subjects who are on stable treatment with macrolide antibiotics (for at least 3 months);
16. Medical history of discontinuation of previous inhaled therapy due to bronchospasm or intolerance;
17. Documented COVID-19 diagnosis within 4 weeks prior to randomisation, or associated complications/symptoms;
18. Diagnosis of alpha-1-antitrypsin (AAT) deficiency defined as an AAT serum level \<110 mg/dL; a prior test result of AAT serum level to confirm the diagnosis will be acceptable. In the event that a prior result is not available, a new test will be performed during the screening period and the result considered for the eligibility at randomisation.
19. Treatment with prohibited concomitant medications or if the subject is expected to take prohibited concomitant medications during the study;
20. Subjects treated with monoclonal antibodies (mAbs) for any respiratory conditions;
21. Subjects with traction BE;
22. For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive serum human chorionic gonadotropin laboratory test. A serum pregnancy test is to be performed at screening, and a urine pregnancy test is to be performed prior to randomisation;
23. Positive HIV1 or HIV2 serology results at screening;
24. Hepatitis serology results which indicate acute or chronic HB or HCV at screening;
25. BMI ≤17 kg/m2 at screening.
See the list of criteria in Part I for subjects with BE (Cohort B), except the exclusion criterion below:
2. Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, hematologic, metabolic, neurological, or psychiatric disorders that may interfere with successful completion of this protocol, according to the investigator's judgment;
3. Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the subject or the evaluation of the results of the study, according to the investigator's judgment;
4. History of respiratory diseases;
5. Positive human immunodeficiency virus (HIV) 1 or HIV2 serology results at screening;
6. Hepatitis serology results which indicate acute or chronic hepatitis B (HB) or hepatitis C virus (HCV) at screening;
7. Documented coronavirus disease 2019 (COVID-19) diagnosis within 2 weeks prior to screening or prior to randomisation, or associated complications/symptoms, which have not resolved within 2 weeks prior to screening;
8. Blood donation or blood loss (equal or more than 450 mL) less than 2 months prior to screening or prior to randomisation;
9. Abnormal liver enzymes at screening or prior to randomisation (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] or bilirubin: \>1.5× upper limit of normal \[ULN\]);
10. Positive urine test for cotinine at screening or prior to randomisation;
11. Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test at screening or prior to randomisation;
12. Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen at screening or prior to randomisation;
13. Treatment with prohibited concomitant medications or if the subject is expected to take prohibited concomitant medications during the study;
14. Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or prior to randomisation;
15. Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the study;
16. Unsuitable veins for repeated venepuncture;
17. Heavy caffeine drinker;
18. For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive serum human chorionic gonadotropin laboratory test. A serum pregnancy test is to be performed at screening and a urine pregnancy test is to be performed prior to randomisation;
19. Use of any kind of electronic smoking devices within 6 months prior to screening.
1. History of a clinically meaningful unstable or uncontrolled chronic comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering the study drug to the subject;
2. Acute symptomatic respiratory tract infection which constitutes an increase from the subject's baseline, per the investigator's judgment, within 4 weeks prior to randomisation;
3. Abnormal and clinically significant 12-lead ECG at screening or prior to randomisation that results in an active medical problem, which may impact the safety of the subject, per the investigator's judgment. Male subjects with QTcF \>450 ms and female subjects with QTcF \>470 ms cannot be enrolled;
4. Clinically significant abnormal laboratory values at screening that, in the opinion of the investigator, may put the subject at risk by participating in the study, or interfere with the subject's treatment or assessment, or influence the results of the study;
5. Participation in another clinical study, where investigational drug was received less than 30 days or less than 5 half-lives of the previous administered product (whichever is longer) prior to screening; participation in another clinical study is also not allowed between screening and randomisation;
6. Primary diagnosis of asthma, as determined by the investigator;
7. Concomitant diagnosis of cystic fibrosis;
8. Diagnosis of chronic obstructive pulmonary disease (COPD) made by a clinician, with airflow obstruction (post-bronchodilator FEV1/FVC ratio \<0.7) and at least a 10 pack-year smoking history; subjects with documented COPD but without airflow obstruction or smoking history will be permitted;
9. Current smokers; ex-smokers must have stopped for at least 1 year prior to screening (≥6 months for electronic smoking devices);
10. Subjects with an active tuberculous mycobacteria (TM) or non-tuberculous mycobacteria (NTM) infection requiring or receiving antibiotic treatment, an active allergic bronchopulmonary aspergillosis requiring treatment with corticosteroids or anti-fungal therapy, and/or a connective tissue disease (CTD) receiving an immunosuppressive treatment equivalent to \>10 mg prednisolone daily or systemic immunosuppression;
11. Diagnosis of common variable immunodeficiency (CVID) or other immunodeficiencies requiring immunoglobulin treatment, based on subject history;
12. Diagnosis of rheumatoid arthritis;
13. Malignancy that has not been in complete remission for at least 1 year or any untreated localised carcinomas;
14. History of solid organ/haematological transplantation and receiving immunosuppressive therapy;
15. Use of any antimicrobials (oral, inhaled, or intravenous) within 4 weeks prior to randomisation, except for subjects who are on stable treatment with macrolide antibiotics (for at least 3 months);
16. Medical history of discontinuation of previous inhaled therapy due to bronchospasm or intolerance;
17. Documented COVID-19 diagnosis within 4 weeks prior to randomisation, or associated complications/symptoms;
18. Diagnosis of alpha-1-antitrypsin (AAT) deficiency defined as an AAT serum level \<110 mg/dL; a prior test result of AAT serum level to confirm the diagnosis will be acceptable. In the event that a prior result is not available, a new test will be performed during the screening period and the result considered for the eligibility at randomisation.
19. Treatment with prohibited concomitant medications or if the subject is expected to take prohibited concomitant medications during the study;
20. Subjects treated with monoclonal antibodies (mAbs) for any respiratory conditions;
21. Subjects with traction BE;
22. For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive serum human chorionic gonadotropin laboratory test. A serum pregnancy test is to be performed at screening, and a urine pregnancy test is to be performed prior to randomisation;
23. Positive HIV1 or HIV2 serology results at screening;
24. Hepatitis serology results which indicate acute or chronic HB or HCV at screening;
25. BMI ≤17 kg/m2 at screening.
See the list of criteria in Part I for subjects with BE (Cohort B), except the exclusion criterion below:
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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James D. Chalmers
Role: PRINCIPAL_INVESTIGATOR
School of Medicine, University of Dundee, UK
Locations
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Royal Papworth Hospital NHS Foundation Trust, Cambridge Centre for Lung Infection
Cambridge, , United Kingdom
Site Status
NOT_YET_RECRUITING
Tayside Medical Science Centre, Ninewells Hospital & Medical School
Dundee, , United Kingdom
Site Status
RECRUITING
NHS Lothian
Edinburgh, , United Kingdom
Site Status
RECRUITING
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Site Status
RECRUITING
The Leeds Teaching Hospitals NHS Trust, Saint James's University Hospital
Leeds, , United Kingdom
Site Status
WITHDRAWN
Royal Bromptom Hospital (NHS Guy's and Thomas')
London, , United Kingdom
Site Status
RECRUITING
Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Site Status
RECRUITING
Medicines Evaluation Unit (MEU)
Manchester, , United Kingdom
Site Status
RECRUITING
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Site Status
NOT_YET_RECRUITING
Countries
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United Kingdom
Central Contacts
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Facility Contacts
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MEU, the Langley Building
Role: primary
0045 (0)161 359 7940
Other Identifiers
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CLI-06333CA1-01
Identifier Type: -
Identifier Source: org_study_id
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