Non-cystic Fibrosis BronchiectasisPhase 2SEADIB1NCT04278040
Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis Bronchiectasis
A Phase 2 study testing Melphalan in people with Non-cystic Fibrosis Bronchiectasis, run by Federal State Budgetary Institution, Pulmonology Scientific Research Institute at 1 site in Russia.
Trial summary
This non-randomised open-label prospective pilot study evaluates the safety and efficacy of inhalations of ultra-low doses of alkylating drug melphalan for the treatment of non-cystic fibrosis bronchiectasis. All patients will receive 0,1 mg of melphalan in 5 daily inhalations 1 time per day. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- Melphalan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jun 2018to 30 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Established diagnosis witn CT scan of non-cystic fibrosis bronchiectasis more than 12 months before the screening visit.
- Sputum expectoration not less than 3 months per year during more than 2 consecutive years
- Willing of the patient for cooperation
- Non-Inclusion Criteria:
- Pregnant and lactating women and all women who are physiologically capable of becoming pregnant, who do not agree to use one or more of the following effective methods of contraception: intrauterine device or intrauterine system; hormonal contraception (implantable and oral preparations, patches); barrier methods of contraception; male sterilization (with appropriate documentation after a vasectomy about the absence of sperm in the ejaculate).
Show all 26Show fewer
- Effective contraception is used throughout the study until the last visit. "True abstinence" is acceptable only if it corresponds to the patient's preferred and habitual way of life.
- Postmenopausal women (physiological menopause is defined as "no menstruation for 12 consecutive months") and women who have undergone sterilization surgery (for example, tubal occlusion, hysterectomy or bilateral salpingectomy) can be included in the study.
- A history of cystic fibrosis.
- Any exacerbation of respiratory infection requiring the use of systemic corticosteroids and / or antibiotics or hospitalization, which developed after the signing of the informed consent form and before the randomization visit (day 1, start of treatment). The criterion should be specified during the randomization visit.
- The presence of hemoptysis at the time of inclusion in the study.
- The presence of diseases of the respiratory tract, in addition to bronchiectasis, which can affect the effectiveness of the study drug and patient safety. Such conditions may include, among others, active tuberculosis, lung cancer, sarcoidosis, chronic obstructive pulmonary disease (COPD) IV (GOLD, 2017), uncontrolled bronchial asthma with respiratory failure, high pulmonary hypertension (> 25 mm Hg), interstitial lung disease, etc.
- Patients with a clinical significant disease of the cardiovascular system (for example, unstable angina, chronic heart failure New York Heart Association (NYHA) III / IV, acute myocardial infarction (within 6 months before inhalation of 1 dose), etc.
- Atrial fibrillation patients.
- Clinical significant 12-lead ECG abnormalities that may affect patient safety. The corrected QT interval (QTc) interval on the electrocardiogram (ECG in 12 leads) is more than 450 ms for men and more than 470 ms for women on screening and randomization visits.
- A history of hypersensitivity to any of the substances used in the study.
- Clinically significant deviations of laboratory parameters, indicating a significant or unstable concomitant disease, which may affect the effectiveness of the study drug or patient safety.
- Hemostasis deviation within 1 month before the first inhalation of the study drug, including confirmed:
- Hemoglobin <10 g / 100 ml;
- White blood cell count <3.0 x 10*9 / L;
- The absolute number of neutrophils ≤ 1.5 x 10*9 / L;
- Platelet count <100 x 10*9 / L.
- Unstable concomitant disease, such as uncontrolled hyperthyroidism, uncontrolled diabetes or other endocrine diseases; significant impairment of liver and kidney function; uncontrolled gastrointestinal diseases (for example, active peptic ulcer); uncontrolled neurological diseases; uncontrolled hematological diseases; uncontrolled autoimmune diseases or other diseases that, according to the researcher, may affect the effectiveness of the study drug and patient safety.
- Alcohol and/or drugs abuse 12 months before screening visit.
- Failure to perform tests to evaluate external respiration function, perform research procedures, or adhere to the treatment schedule provided for in the study.
- Participation in another clinical trial in which the study drug was administered less than 8 weeks before the screening visit.
Who cannot join
- Informed consent withdrawn by the patient.
- The patient doesn't follow the instructions of the research staff regarding the requirements of the research protocol.
- Unable to contact patient.
- The researcher believes that participation in the study is not in the interests of the patient and / or further participation in the study is unsafe for the patient's health.
- There is a violation of the criteria for inclusion and / or non-inclusion in the study.
- The patient has developed adverse event, which, according to the researcher, makes further participation in the study unsafe for the patient.
- The licensing authority or ethics committee, for any reason, decides to discontinue the entire study or close this research center.
- A female patient becomes pregnant, is planning a pregnancy, or is breastfeeding while participating in this study.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Kirill Zykov
Moscow, 115682
Evgeny Sinitsyn, +79269490744, sinymlad@list.ru
Kirill Zykov, Prof, +9257729462, kirillaz@inbox.ru
About this study
Official title: Safety, Tolerability and Efficacy of Ultra-low Doses of Alkylating Drug Melphalan Inhalations for the Treatment of Non-cystic Fibrosis Bronchiectasis
This non-randomised open-label prospective pilot study evaluates the safety and efficacy of inhalations of ultra-low doses of alkylating drug melphalan for the treatment of non-cystic fibrosis bronchiectasis. All patients will receive 0,1 mg of melphalan in 5 daily inhalations 1 time per day.
Read the detailed description
It was previously shown that in ultra-low (more than 100 times lower than conventional therapeutic) doses inhalations of alkylating drug (melphalan) are effective in severe steroid-resistant bronchial asthma, a form of the disease often characterized by neutrophilic type of inflammation. The exacerbation frequency reduced after the treatment, steroid-sparing effect was shown, morphological signs of bronchial epithelial regeneration were revealed and quality of life of asthmatic patients, treated with ultra-low doses of melphalan, improved. In preclinical studies and studies with volunteers, it was found that inhalations of ultra-low doses of melphalan do not have cytotoxic properties, but have local and systemic anti-inflammatory effects and decrease the activation of lymphocytes due to blockade of heavy β-chain of the interleukin (IL)-2 surface receptor. In addition, in ultra-low concentrations, alkylating agents are able to disrupt the cell signalling through the receptor for tumor necrosis factor, thereby exerting a protective effect from the cytotoxic activity of tumor necrosis factor (TNF)-α, which leads to the anti-inflammatory response. It can be assumed that the inhalation use of ultra-low doses of melphalan can be effective in patients with bronchiectasis, as in a disease characterized by a neutrophilic type of inflammation, leading to the improvement of quality of life, increasing the time to the first exacerbation and decreasing of exacerbation frequency.
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- Melphalan
- Keywords
- bronchiectasis, treatment, inhalation, low doses, alkylating drugs
- Medical subject headings
- Bronchiectasis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
Also called Alkeran
Inhalations with low doses of Melphalan for 5 consequent days
| Study group | Role | What they receive |
|---|---|---|
| Non-cystic fibrosis bronchiectasis (NCFB) patients | Experimental | Inhalations with Melphalan 0,1 mg dissolved in 2 ml sodium chloride (NaCl) 0,9% 1 per day for 5 consequent days Receives: Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of drug-related side effects.
The evaluation of side-effects, typical for the conventional therapeutic doses of melphalan (cough, bronchospasm, pulmonary fibrosis, interstitial pneumonitis; anorexia, gastrointestinal bleeding, ulcers of the stomach and duodenum, stomatitis, nausea, vomiting, esophagitis, diarrhea; myelodepression (leukopenia, thrombocytopenia, anemia), hemolytic anemia, bleeding and hemorrhage, vasculitis, veno-occlusive lesions, asystole; impaired urination, hematuria, hyperuricemia, nephropathy, edema, proteinuria, ovarian hypofunction, amenorrhea, azoospermia; anaphylaxis, anaphylactic shock, Quincke's edema, urticaria, skin rash, itching; dysfunction of the central nervous system, pain (back, side pain), the development of infections, fever, chills, alopecia, an increase in the concentration of 5-hydroxyindoleacetic acid, necrosis of the perivascular space, a feeling of heat and / or tingling at the injection site)
Measured: 6 months from the first inhalation
Secondary outcomes (2)
The changes of The St George's Respiratory Questionnaire (SGRQ)
The evaluation of changes in quality of life with the SGRQ questionnaire (50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction). Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. Lower score means a better the quality of life. A minimum change in score of 4 units was established as clinically relevant.
Measured: Day1 - Day 177 (±7 days)
The changes of The Quality of Life-Bronchiectasis (QOL-B) questionnaire
The Quality of Life-Bronchiectasis (QOL-B), a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis bronchiectasis, contains 37 items on 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden).The minimal important difference score for the Respiratory Symptoms scale is 8.0 points. Higher scores represent a better quality of life.
Measured: Day1 - Day 177 (±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start20 Jun 2018
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, Pulmonology Scientific Research Institute
- Sponsor type
- Other government
- Collaborators
- Moscow State University of Medicine and Dentistry
- Responsible party
- Principal investigator, Kirill Zykov, Federal State Budgetary Institution, Pulmonology Scientific Research Institute
- Investigators
- Kirill Zykov, Prof, Principal investigator, Federal State Budgetary Institution, Pulmonology Scientific Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278040
- Sponsor's protocol ID
- PSRI02-18
- Acronym
- SEADIB1
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.
PubMed 28889110Pukhalsky AL, Shmarina GV. Stimulatory and protective effects of alkylating agents applied in ultra-low concentrations. Pharmacology. 2001;62(3):129-32. doi: 10.1159/000056084.
PubMed 11287812Shmarina G, Pukhalsky A, Alioshkin V, Sabelnikov A. Melphalan reduces the severity of experimental colitis in mice by blocking tumor necrosis factor-alpha signaling pathway. Ann N Y Acad Sci. 2007 Jan;1096:97-105. doi: 10.1196/annals.1397.075.
PubMed 17405921Pukhalsky A, Shmarina G, Alioshkin V, Sabelnikov A. Alkylating drugs applied in non-cytotoxic doses as a novel compounds targeting inflammatory signal pathway. Biochem Pharmacol. 2006 Nov 30;72(11):1432-8. doi: 10.1016/j.bcp.2006.03.008. Epub 2006 Mar 14.
PubMed 16620792Pukhal'skii AL, Shmarina GV, Zykov KA, Aleshkin VA. [Effect of steroid therapy on the clinical course of bronchial asthma]. Vestn Ross Akad Med Nauk. 2009;(6):3-9. Russian.
PubMed 19645099Martinez-Garcia MA, Maiz L, Olveira C, Giron RM, de la Rosa D, Blanco M, Canton R, Vendrell M, Polverino E, de Gracia J, Prados C. Spanish Guidelines on the Evaluation and Diagnosis of Bronchiectasis in Adults. Arch Bronconeumol (Engl Ed). 2018 Feb;54(2):79-87. doi: 10.1016/j.arbres.2017.07.015. Epub 2017 Nov 9. English, Spanish.
PubMed 29128130Sinitsyn EA., Zykov KA. Non-cystic Fibrosis Bronchiectasis: Actual Problem Review and Treatment Prospects. Journal of Clinical Practice.2018;9(4):55-64. doi: https://doi.org/10.17816/clinpract9455-64
Chalmers JD, Chotirmall SH. Bronchiectasis: new therapies and new perspectives. Lancet Respir Med. 2018 Sep;6(9):715-726. doi: 10.1016/S2213-2600(18)30053-5. Epub 2018 Feb 23.
PubMed 29478908
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Efficacy of Ultra-low Doses of Alkylating Drug Melphalan Inhalations for the Treatment of Non-cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT04278040
- Acronym / sponsor ID
- SEADIB1 / PSRI02-18
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Keywords
- bronchiectasis, treatment, inhalation, low doses, alkylating drugs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, Pulmonology Scientific Research InstituteOther government
- Collaborators
- Moscow State University of Medicine and Dentistry
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 20 Feb 2020 (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.
This non-randomised open-label prospective pilot study evaluates the safety and efficacy of inhalations of ultra-low doses of alkylating drug melphalan for the treatment of non-cystic fibrosis bronchiectasis. All patients will receive 0,1 mg of melphalan in 5 daily inhalations 1 time per day.
Detailed description
It was previously shown that in ultra-low (more than 100 times lower than conventional therapeutic) doses inhalations of alkylating drug (melphalan) are effective in severe steroid-resistant bronchial asthma, a form of the disease often characterized by neutrophilic type of inflammation. The exacerbation frequency reduced after the treatment, steroid-sparing effect was shown, morphological signs of bronchial epithelial regeneration were revealed and quality of life of asthmatic patients, treated with ultra-low doses of melphalan, improved. In preclinical studies and studies with volunteers, it was found that inhalations of ultra-low doses of melphalan do not have cytotoxic properties, but have local and systemic anti-inflammatory effects and decrease the activation of lymphocytes due to blockade of heavy β-chain of the interleukin (IL)-2 surface receptor. In addition, in ultra-low concentrations, alkylating agents are able to disrupt the cell signalling through the receptor for tumor necrosis factor, thereby exerting a protective effect from the cytotoxic activity of tumor necrosis factor (TNF)-α, which leads to the anti-inflammatory response. It can be assumed that the inhalation use of ultra-low doses of melphalan can be effective in patients with bronchiectasis, as in a disease characterized by a neutrophilic type of inflammation, leading to the improvement of quality of life, increasing the time to the first exacerbation and decreasing of exacerbation frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-cystic fibrosis bronchiectasis (NCFB) patients | Experimental | Drug: MelphalanInhalations with Melphalan 0,1 mg dissolved in 2 ml sodium chloride (NaCl) 0,9% 1 per day for 5 consequent days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Signed informed consent form
- Established diagnosis witn CT scan of non-cystic fibrosis bronchiectasis more than 12 months before the screening visit.
- Sputum expectoration not less than 3 months per year during more than 2 consecutive years
- Willing of the patient for cooperation
- Pregnant and lactating women and all women who are physiologically capable of becoming pregnant, who do not agree to use one or more of the following effective methods of contraception: intrauterine device or intrauterine system; hormonal contraception (implantable and oral preparations, patches); barrier methods of contraception; male sterilization (with appropriate documentation after a vasectomy about the absence of sperm in the ejaculate).
Key exclusion criteria (8 listed)
- Informed consent withdrawn by the patient.
- The patient doesn't follow the instructions of the research staff regarding the requirements of the research protocol.
- Unable to contact patient.
- The researcher believes that participation in the study is not in the interests of the patient and / or further participation in the study is unsafe for the patient's health.
- There is a violation of the criteria for inclusion and / or non-inclusion in the study.
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 |
|---|---|---|
| MelphalanAlso: AlkeranInhalations with low doses of Melphalan for 5 consequent days | Drug | Non-cystic fibrosis bronchiectasis (NCFB) patients |
Primary outcome
Frequency of drug-related side effects.
Time frame: 6 months from the first inhalation
The evaluation of side-effects, typical for the conventional therapeutic doses of melphalan (cough, bronchospasm, pulmonary fibrosis, interstitial pneumonitis; anorexia, gastrointestinal bleeding, ulcers of the stomach and duodenum, stomatitis, nausea, vomiting, esophagitis, diarrhea; myelodepression (leukopenia, thrombocytopenia, anemia), hemolytic anemia, bleeding and hemorrhage, vasculitis, veno-occlusive lesions, asystole; impaired urination, hematuria, hyperuricemia, nephropathy, edema, proteinuria, ovarian hypofunction, amenorrhea, azoospermia; anaphylaxis, anaphylactic shock, Quincke's edema, urticaria, skin rash, itching; dysfunction of the central nervous system, pain (back, side pain), the development of infections, fever, chills, alopecia, an increase in the concentration of 5-hydroxyindoleacetic acid, necrosis of the perivascular space, a feeling of heat and / or tingling at the injection site)
2 secondary outcomes
The changes of The St George's Respiratory Questionnaire (SGRQ)
Time frame: Day1 - Day 177 (±7 days)
The changes of The Quality of Life-Bronchiectasis (QOL-B) questionnaire
Time frame: Day1 - Day 177 (±7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 28889110Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.
- Background: PubMed 11287812Pukhalsky AL, Shmarina GV. Stimulatory and protective effects of alkylating agents applied in ultra-low concentrations. Pharmacology. 2001;62(3):129-32. doi: 10.1159/000056084.
- Background: PubMed 17405921Shmarina G, Pukhalsky A, Alioshkin V, Sabelnikov A. Melphalan reduces the severity of experimental colitis in mice by blocking tumor necrosis factor-alpha signaling pathway. Ann N Y Acad Sci. 2007 Jan;1096:97-105. doi: 10.1196/annals.1397.075.
- Background: PubMed 16620792Pukhalsky A, Shmarina G, Alioshkin V, Sabelnikov A. Alkylating drugs applied in non-cytotoxic doses as a novel compounds targeting inflammatory signal pathway. Biochem Pharmacol. 2006 Nov 30;72(11):1432-8. doi: 10.1016/j.bcp.2006.03.008. Epub 2006 Mar 14.
- Background: PubMed 19645099Pukhal'skii AL, Shmarina GV, Zykov KA, Aleshkin VA. [Effect of steroid therapy on the clinical course of bronchial asthma]. Vestn Ross Akad Med Nauk. 2009;(6):3-9. Russian.
- Background: PubMed 29128130Martinez-Garcia MA, Maiz L, Olveira C, Giron RM, de la Rosa D, Blanco M, Canton R, Vendrell M, Polverino E, de Gracia J, Prados C. Spanish Guidelines on the Evaluation and Diagnosis of Bronchiectasis in Adults. Arch Bronconeumol (Engl Ed). 2018 Feb;54(2):79-87. doi: 10.1016/j.arbres.2017.07.015. Epub 2017 Nov 9. English, Spanish.
- BackgroundSinitsyn EA., Zykov KA. Non-cystic Fibrosis Bronchiectasis: Actual Problem Review and Treatment Prospects. Journal of Clinical Practice.2018;9(4):55-64. doi: https://doi.org/10.17816/clinpract9455-64
- Background: PubMed 29478908Chalmers JD, Chotirmall SH. Bronchiectasis: new therapies and new perspectives. Lancet Respir Med. 2018 Sep;6(9):715-726. doi: 10.1016/S2213-2600(18)30053-5. Epub 2018 Feb 23.
- Individual participant dataSharing planned: No
Related trials for Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingPhase 1
Phase 1 Study to Assess the Effects of HSK31858 on the QT/QTc Interval in Healthy Chinese Participants
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingObservational study
Study of Bronchiectasis and Associated Cardiovascular Comorbidities
Bronchiectasis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
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.
Kirill Zykov, Prof principal investigator
Federal State Budgetary Institution, Pulmonology Scientific Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melphalan in people with Non-cystic Fibrosis Bronchiectasis, run by Federal State Budgetary Institution, Pulmonology Scientific Research Institute at 1 site in Russia.
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 26 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Feb 2020. 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 Russia. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Sinitsyn (+79269490744, sinymlad@list.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of drug-related side effects. (time frame: 6 months from the first inhalation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278040, which also lists 8 linked publications.
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 20 Feb 2020.