Chronic Obstructive Pulmonary Disease (COPD)Early Phase 1PAEANNCT03449459
Prevention of Acute Exacerbation in Subjects With COPD by Bacterial Decolonization in Lower Respiratory Tract
A Early Phase 1 study testing oral probiotics, aerosol inhaled amikacin and combined vaccination in people with Chronic Obstructive Pulmonary Disease (COPD), run by Shanghai Zhongshan Hospital at 3 sites in China.
Trial summary
The colonization of potential pathogenic bacteria in lower respiratory tract is thought to be accountable for acute exacerbation in subjects with moderate to severe COPD. However, there is no accepted therapy for patients with COPD to remove the colonized bacteria in lower respiratory tract. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- oral probiotics, aerosol inhaled amikacin and combined vaccination
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 3 sitesChina
- Study dates
- 1 Dec 2018to 1 Dec 2020
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed
- Male or female adults aged 18-65 years
- Diagnosed with COPD according to GOLD 2016 (The ratio of post-bronchodilator forced expiratory volume in 1 second (FEV1) to force vital capacity (FVC)<0.70 with the use of salbutamol 400ug)
- Moderate to very severe airflow limitation (post-bronchodilator FEV1 < 80% of the predicted normal value)
- A documented history of at least 2 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticoids and/or antibiotics, or at least 1 exacerbation in the previous 12 months that requires hospitalization.
- In the stable stage of COPD
Who cannot join
- Patients who have clinically significant and chronic hepatic, renal, cardiovascular and gastrointestinal abnormalities or malignant tumor (except for lung cancer) which could interfere with the assessment of the efficacy and safety of the study treatment
- Patients who are in critical conditions
- Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids or an acute exacerbation of any other diseases in the 4 weeks prior to screening
- Patients with concomitant pulmonary disease (including but not limited to bronchiectasis, interstitial lung disease, asthma)
- Patients who are highly likely to be lost during the 3-month treatment and the 1-year follow up
- Pregnant or nursing (lactating) women
Show all 10Show fewer
- Patients who have been vaccinated against influenza in the current year, or against Streptococcus pneumoniae within five years, or have vaccination contraindications
- Patients who are allergic to amikacin or other aminoglycosides
- Patients who have participated in any interventional clinical trials in the three months prior to screening
- Patients with mental diseases or cognitive disorders which could interfere with treatment and follow-up
Trial locations and contacts
3 sites in 1 country.
China3 sites
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Randomized, Parallel, Controlled, Exploratory Study: the Efficacy and Safety of Taking Probiotics, Inhaled Antibiotics or Combined Vaccination to Prevent Acute Exacerbation in Subjects With Moderate to Severe COPD and Decolonize Bacteria in Lower Respiratory Tract.
The colonization of potential pathogenic bacteria in lower respiratory tract is thought to be accountable for acute exacerbation in subjects with moderate to severe COPD. However, there is no accepted therapy for patients with COPD to remove the colonized bacteria in lower respiratory tract. Therefore, we plan to perform a multi-center, randomized, controlled trial to study the efficacy and safety of oral probiotics, aerosol inhaled amikacin or combined vaccination to decolonize bacteria in lower respiratory tract and prevent acute exacerbation of COPD.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by incomplete reversible airflow limitation, small airway obstruction and alveolar structural damage. About 3 million patients die from COPD every year around the world. The prevalence of COPD in Chinese people over the age of 40 is as high as 12 % and has risen by 50 % in the past nine years.
Acute exacerbation is the leading cause of death in patients with COPD , and accounts for a majority of expenditure of COPD management. The colonization of potential pathogenic bacteria in the lower respiratory tract is an important cause of the acute exacerbation especially in patients with moderate and severe COPD.
Some clinical studies show that aerosol inhaled antibiotics is promising in reducing acute exacerbation, but these exploratory studies have some defects so that they can't back up for the clinical application of aerosol inhaled antibiotics. Amikacin, a kind of aminoglycosides, is sensitive to the common pathogens of acute exacerbation of COPD in China. Therefore it is necessary to carry out a clinical trial to verify its efficacy and safety in pathogen decolonization and prevention of acute exacerbation.
In addition, owing to bacterial resistance and insufficient antibiotics concentration in lower respiratory tract, developing new antibacterial materials is necessary. Oral probiotics is an another way to regulate the bacterial load and inflammatory response in lower respiratory tract, which has been proven to effectively prevent acute exacerbation in cystic fibrosis and childhood asthma. Likewise, airway bacterial burden and inflammation are two main mechanisms of acute exacerbation in COPD. Hence, considering its convenience and safety of oral probiotics, we perform a trial to make clinical evaluation for it.
What's more, influenza and streptococcus pneumoniae vaccines are separately recommended for patients with COPD in the Global Initiative for Chronic Obstructive Pulmonary Disease(GOLD), but there have been no studies on the effects of combined vaccination on bacterial decolonization in lower respiratory tract or on the prevention of acute exacerbation.
Effects of these above methods on the decolonization of potential pathogenic bacteria in lower respiratory tract and the inflammatory reaction are not clear. Therefore, we plan to perform a multi-center, randomized, controlled trial to study the efficacy and safety of oral probiotics, aerosol inhaled amikacin or combined vaccination to decolonize bacteria in lower respiratory tract and prevent acute exacerbation of COPD.
- Being tested
- oral probiotics, aerosol inhaled amikacin, combined vaccination
- Keywords
- chronic obstructive pulmonary disease, aerosol inhaled amikacin, oral probiotics, combined influenza and pneumococcal vaccine inoculation, bacterial decolonization in lower respiratory tract
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral probioticsDietary supplement
Culturelle™ DIGESTIVE HEALTH 30 CT(VCAP)(10 Billion Claim) which consists of 100% Lactobacillus rhamnosus GG, 1 tablet, q.d., for 3 months.
Subjects will take conventional therapy at the same time.
aerosol inhaled amikacinDrug
0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 5-7 days per month, for 3 months.
In order to observe and cope with adverse events timely, subjects will be admitted to the ward during the course of medication.
Subjects will take conventional therapy at the same time.
combined vaccinationBiological
Influenza Vaccine recommended by World Health Organization(WHO) in that year and imported 23-Valent Pneumococcal Polysaccharide Vaccine approved by China Food and Drug Administration(CFDA) are vaccinated at different body sites by professional nurses.
The interval between two vaccinations is 3-5 days to avoid the overlap of adverse events.
Subjects will take conventional therapy at the same time.
| Study group | Role | What they receive |
|---|---|---|
| oral probiotics | Experimental | Not described Receives: Dietary Supplement: oral probiotics |
| aerosol inhaled amikacin | Experimental | Not described Receives: Drug: aerosol inhaled amikacin |
| combined vaccination | Experimental | Not described Receives: Biological: combined vaccination |
| conventional therapy (blank control) | No intervention | According to the subjects' personal characteristics and guidance of The Global Initiative for Chronic Obstructive Lung Disease(GOLD) 2017, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled glucocorticoids and long term oxygen therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first COPD exacerbation
COPD exacerbation refers to deterioration of patients' daily symptoms requiring treatment with antibiotics or systemic glucocorticoid therapy.
First COPD exacerbations starting between first dose and one day after last follow-up are included.
Measured: 15 months
Secondary outcomes (10)
Colonization of potential pathogenic bacteria in induced sputum
Induced sputum represents the specimen from lower respiratory tract and should be processed within six hours after collection. Sputum plugs were separated from contaminating saliva by macroscopic examination using sterile forceps. Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis and Pseudomonas aeruginosa which are the top four bacteria involved in acute exacerbation of COPD are defined as potential pathogenic bacteria. Using the plate count method, when the colony number of above four bacteria is over 100 cfu/ml，we define this bacteria as colonized bacteria in lower respiratory tract.
Measured: Baseline, 3 months
Microbiome in induced sputum
Induced sputum represents the specimen from lower respiratory tract and should be processed within six hours after collection. Sputum plugs were separated from contaminating saliva by macroscopic examination using sterile forceps and weighed. Bacterial genomic DNA was isolated from sputum plugs of the same weight using the specific kits. The 16S bacterial ribosomal RNA genes were Polymerase Chain Reaction (PCR)-amplified with the appropriate controls against reagent contamination. Amplified DNA fragments were sequenced using the specific sequencing platform. Sequencing reads were processed and analyzed by the specific algorithm and software. The composition and diversity of microbiome are represented by major taxonomic groups at both phylum and genus levels. If necessary, Quantitative PCR for 16S rRNA gene will be performed to validate the results of sequencing. By using these methos, we can detect the microbiome's composition and its shift.
Measured: Baseline, 3 months
Forced Expiratory Volume in 1 Second
Change from baseline. Pulmonary function assessments were performed using centralized spirometry according to international standards. FEV1 was measured after 15 minutes of inhaling salbutamol 400ug.
Measured: Baseline, 3 months, 15 months
COPD Assessment Test(CAT) Score
The COPD Assessment Test (CAT) is an 8-item uni-dimensional measure of health status impairment in COPD, containing 6 grades from 0 to 5.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
modified Medical Research Council(mMRC) scale
The modified Medical Research Council scale is a simple and powerful tool to evaluate the breathlessness, containing 5 grades from 0 to 4.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
serum C-reactive protein(CRP) levels
Serum CRP level is a sensitive marker of the systemic inflammation.
Measured: Baseline, 3 months
interleukin(IL)-6 in induced sputum
Induced sputum represents the specimen from lower respiratory tract. Sputum supernatant was batch analysed for the cytokines IL-6 using commercial highsensitivity sandwich ELISA kits. Inflammatory factors represent local inflammation levels in lower respiratory tract.
Measured: Baseline, 3 months
IL-8 in induced sputum
Induced sputum represents the specimen from lower respiratory tract. Sputum supernatant was batch analysed for the cytokines IL-8 using commercial highsensitivity sandwich ELISA kits. Inflammatory factors represent local inflammation levels in lower respiratory tract.
Measured: Baseline, 3 months
IL-1β in induced sputum
Induced sputum represents the specimen from lower respiratory tract. Sputum supernatant was batch analysed for the cytokines IL-1β using commercial highsensitivity sandwich ELISA kits. Inflammatory factors represent local inflammation levels in lower respiratory tract.
Measured: Baseline, 3 months
Number of Patients With Adverse Events, Serious Adverse Events, and Death
The overall rate of adverse events reported from initiation to the last time follow-up. Some laboratory examinations, such as blood routine, hepatorenal function and electrocardiogram, are performed twice separately at baseline and completion of intervention(3 months) in order to evaluate the safety of interventions.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Dec 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are equally assigned to four groups in parallel to accept oral probiotics, aerosol inhaled amikacin, combined vaccination or blank control for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, MD, PhD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449459
- Sponsor's protocol ID
- B2017-197R
- Other IDs
- 2017YFC1309303
- Acronym
- PAEAN
- Status last verified
- Nov 2018
- First submitted
- 12 Feb 2018
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hua JL, Yang ZF, Cheng QJ, Han YP, Li ZT, Dai RR, He BF, Wu YX, Zhang J. Prevention of exacerbation in patients with moderate-to-very severe COPD with the intent to modulate respiratory microbiome: a pilot prospective, multi-center, randomized controlled trial. Front Med (Lausanne). 2024 Jan 5;10:1265544. doi: 10.3389/fmed.2023.1265544. eCollection 2023.
PubMed 38249987
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Controlled, Exploratory Study: the Efficacy and Safety of Taking Probiotics, Inhaled Antibiotics or Combined Vaccination to Prevent Acute Exacerbation in Subjects With Moderate to Severe COPD and Decolonize Bacteria in Lower Respiratory Tract.
- ClinicalTrials.gov ID
- NCT03449459
- Acronym / sponsor ID
- PAEAN / B2017-197R
- Keywords
- chronic obstructive pulmonary disease, aerosol inhaled amikacin, oral probiotics, combined influenza and pneumococcal vaccine inoculation, bacterial decolonization in lower respiratory tract
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Ruijin Hospital
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 28 Feb 2018 (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.
The colonization of potential pathogenic bacteria in lower respiratory tract is thought to be accountable for acute exacerbation in subjects with moderate to severe COPD. However, there is no accepted therapy for patients with COPD to remove the colonized bacteria in lower respiratory tract. Therefore, we plan to perform a multi-center, randomized, controlled trial to study the efficacy and safety of oral probiotics, aerosol inhaled amikacin or combined vaccination to decolonize bacteria in lower respiratory tract and prevent acute exacerbation of COPD.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by incomplete reversible airflow limitation, small airway obstruction and alveolar structural damage. About 3 million patients die from COPD every year around the world. The prevalence of COPD in Chinese people over the age of 40 is as high as 12 % and has risen by 50 % in the past nine years.
Acute exacerbation is the leading cause of death in patients with COPD , and accounts for a majority of expenditure of COPD management. The colonization of potential pathogenic bacteria in the lower respiratory tract is an important cause of the acute exacerbation especially in patients with moderate and severe COPD.
Some clinical studies show that aerosol inhaled antibiotics is promising in reducing acute exacerbation, but these exploratory studies have some defects so that they can't back up for the clinical application of aerosol inhaled antibiotics. Amikacin, a kind of aminoglycosides, is sensitive to the common pathogens of acute exacerbation of COPD in China. Therefore it is necessary to carry out a clinical trial to verify its efficacy and safety in pathogen decolonization and prevention of acute exacerbation.
In addition, owing to bacterial resistance and insufficient antibiotics concentration in lower respiratory tract, developing new antibacterial materials is necessary. Oral probiotics is an another way to regulate the bacterial load and inflammatory response in lower respiratory tract, which has been proven to effectively prevent acute exacerbation in cystic fibrosis and childhood asthma. Likewise, airway bacterial burden and inflammation are two main mechanisms of acute exacerbation in COPD. Hence, considering its convenience and safety of oral probiotics, we perform a trial to make clinical evaluation for it.
What's more, influenza and streptococcus pneumoniae vaccines are separately recommended for patients with COPD in the Global Initiative for Chronic Obstructive Pulmonary Disease(GOLD), but there have been no studies on the effects of combined vaccination on bacterial decolonization in lower respiratory tract or on the prevention of acute exacerbation.
Effects of these above methods on the decolonization of potential pathogenic bacteria in lower respiratory tract and the inflammatory reaction are not clear. Therefore, we plan to perform a multi-center, randomized, controlled trial to study the efficacy and safety of oral probiotics, aerosol inhaled amikacin or combined vaccination to decolonize bacteria in lower respiratory tract and prevent acute exacerbation of COPD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants are equally assigned to four groups in parallel to accept oral probiotics, aerosol inhaled amikacin, combined vaccination or blank control for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| oral probiotics | Experimental | Dietary Supplement: oral probiotics |
| aerosol inhaled amikacin | Experimental | Drug: aerosol inhaled amikacin |
| combined vaccination | Experimental | Biological: combined vaccination |
| conventional therapy (blank control) | No intervention | –According to the subjects' personal characteristics and guidance of The Global Initiative for Chronic Obstructive Lung Disease(GOLD) 2017, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled glucocorticoids and long term oxygen therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent must be obtained before any assessment is performed
- Male or female adults aged 18-65 years
- Diagnosed with COPD according to GOLD 2016 (The ratio of post-bronchodilator forced expiratory volume in 1 second (FEV1) to force vital capacity (FVC)<0.70 with the use of salbutamol 400ug)
- Moderate to very severe airflow limitation (post-bronchodilator FEV1 < 80% of the predicted normal value)
- A documented history of at least 2 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticoids and/or antibiotics, or at least 1 exacerbation in the previous 12 months that requires hospitalization.
Key exclusion criteria (10 listed)
- Patients who have clinically significant and chronic hepatic, renal, cardiovascular and gastrointestinal abnormalities or malignant tumor (except for lung cancer) which could interfere with the assessment of the efficacy and safety of the study treatment
- Patients who are in critical conditions
- Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids or an acute exacerbation of any other diseases in the 4 weeks prior to screening
- Patients with concomitant pulmonary disease (including but not limited to bronchiectasis, interstitial lung disease, asthma)
- Patients who are highly likely to be lost during the 3-month treatment and the 1-year follow up
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 |
|---|---|---|
| oral probioticsCulturelle™ DIGESTIVE HEALTH 30 CT(VCAP)(10 Billion Claim) which consists of 100% Lactobacillus rhamnosus GG, 1 tablet, q.d., for 3 months. Subjects will take conventional therapy at the same time. | Dietary supplement | oral probiotics |
| aerosol inhaled amikacin0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 5-7 days per month, for 3 months. In order to observe and cope with adverse events timely, subjects will be admitted to the ward during the course of medication. Subjects will take conventional therapy at the same time. | Drug | aerosol inhaled amikacin |
| combined vaccinationInfluenza Vaccine recommended by World Health Organization(WHO) in that year and imported 23-Valent Pneumococcal Polysaccharide Vaccine approved by China Food and Drug Administration(CFDA) are vaccinated at different body sites by professional nurses. The interval between two vaccinations is 3-5 days to avoid the overlap of adverse events. Subjects will take conventional therapy at the same time. | Biological | combined vaccination |
Primary outcome
Time to the first COPD exacerbation
Time frame: 15 months
COPD exacerbation refers to deterioration of patients' daily symptoms requiring treatment with antibiotics or systemic glucocorticoid therapy. First COPD exacerbations starting between first dose and one day after last follow-up are included.
10 secondary outcomes
Colonization of potential pathogenic bacteria in induced sputum
Time frame: Baseline, 3 months
Microbiome in induced sputum
Time frame: Baseline, 3 months
Forced Expiratory Volume in 1 Second
Time frame: Baseline, 3 months, 15 months
COPD Assessment Test(CAT) Score
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
modified Medical Research Council(mMRC) scale
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
serum C-reactive protein(CRP) levels
Time frame: Baseline, 3 months
interleukin(IL)-6 in induced sputum
Time frame: Baseline, 3 months
IL-8 in induced sputum
Time frame: Baseline, 3 months
IL-1β in induced sputum
Time frame: Baseline, 3 months
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Derived from this study: PubMed 38249987Hua JL, Yang ZF, Cheng QJ, Han YP, Li ZT, Dai RR, He BF, Wu YX, Zhang J. Prevention of exacerbation in patients with moderate-to-very severe COPD with the intent to modulate respiratory microbiome: a pilot prospective, multi-center, randomized controlled trial. Front Med (Lausanne). 2024 Jan 5;10:1265544. doi: 10.3389/fmed.2023.1265544. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jing Zhang, MD, PhD principal investigator
Shanghai Zhongshan Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing oral probiotics, aerosol inhaled amikacin and combined vaccination in people with Chronic Obstructive Pulmonary Disease (COPD), run by Shanghai Zhongshan Hospital at 3 sites in China.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to the first COPD exacerbation (time frame: 15 months). 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 NCT03449459, which also lists 1 linked publication.
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 23 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.