COPDNCT03924843
mRNA and miRNA Airway Inflammatory Markers
An observational study of COPD and COPD Exacerbation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This study investigates cytokine Messenger (mRNA) and microRNA (miRNA) level expression of interleukin (IL) -6, IL-8, IL-17, tumor necrosis factor (TNF)-alpha, monocyte chemoattractant protein (MCP)-1, macrophage inflammatory protein (MIP)-1 beta and transforming growth factor (TGF)-beta regarding their… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, COPD Exacerbation
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Nov 2017to 30 Mar 2021
- Phase
- Observational
- 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 40 years and older
- All sexes
- Adult, Older adult
Study population: Twenty COPD patients with an initial COPD exacerbation will be followed for a period of seven weeks for three consecutive visits
Who may be able to join
- Men/Women age >40 years.
- Diagnoses of COPD according to criteria of the American Thoracic Society (ATS), a disease state characterized by the presence of chronic airway obstruction due to chronic bronchitis (cough/sputum on most days a week for 3 months in a year for at least two successive years) and/or emphysema
- Diagnosis of moderate or severe COPD exacerbation (see "Definitions")
- FEV1 > 0.8 L and ability to produce sputum after hypertonic saline production
- Post bronchodilator FEV1/Forced Vital Capacity (FVC) ratio <70 % and post bronchodilator FEV1< 80% pred.
- A smoking history of >10 pack years
Who cannot join
- Pneumonia as determined by X-ray
- > 48 h intake of prednisolon/antibiotics
- Need for mechanical ventilation (either invasive or non-invasive)
- Treatment with immune-modulating agents for any disease
- Experimental interventions for COPD last half year
- Former/concomitant diagnosis of asthma
Show all 9Show fewer
- Any significant other pulmonary disease or disorder
- Other significant disease or disorder (like alpha-1-antitrypsine deficiency, significant bronchiectasis, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic (including diagnosed diabetes), malignant, psychiatric, major physical impairment), which, in the opinion of the investigators may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study.
- Existing pregnancy/ current willingness for becoming pregnant
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center; Department of Pulmonary Diseases
Groningen
About this study
Official title: Responsivity and Reproducibility of Messenger and Micro RNA Airway Inflammatory Markers - a Pilot Study
This study investigates cytokine Messenger (mRNA) and microRNA (miRNA) level expression of interleukin (IL) -6, IL-8, IL-17, tumor necrosis factor (TNF)-alpha, monocyte chemoattractant protein (MCP)-1, macrophage inflammatory protein (MIP)-1 beta and transforming growth factor (TGF)-beta regarding their reproducibility and responsivity in induced sputum and nasal mucosa of patients with chronic obstructive pulmonary disease (COPD) in order to assess their potential as a biomarker outcome measure.
Read the detailed description
Rationale:There is an increased interest to identify sensitive airway biomarkers in order to evaluate the potential and efficacy of anti-inflammatory and -remodelling therapeutic interventions. Biomarkers should be easily obtainable, reliable and valid. In COPD, easily obtainable would suggest use of blood, or more directly associated with the airways: sputum or epithelial brushes. Sputum is an obvious opportunity. It has been shown that gene expression changes in the nasal mucosa might be used as suitable surrogate for epithelial cells of the lower airways in patients with airway inflammatory diseases. However, further studies are needed to validate these assumptions. Measurement of messenger RNA, and of micro RNA derived from sputum samples and nasal brushes would fulfil the ease of use required of a biomarker. Messenger RNA would allow for easier quantification in variable dilution samples (sputum). The Groningen Research Institute for Asthma and COPD (GRIAC research group) has experience with sputum and nasal brushes, mRNA and miRNA, but more information is needed on especially reproducibility of the measurements, as well as on responsivity. Both are a prerequisite when designing new intervention trials with such biomarkers.
Therefore, the aim of this study is to investigate cytokine messenger and microRNA level expression of IL-6, IL-8, IL-17, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta regarding their reproducibility and responsivity in induced sputum and nasal mucosa of COPD patients in order to assess their potential as an objective outcome measure.
The primary objectives of this prospective pilot study are the determination of the reproducibility and responsivity of mRNA level expression of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta, ECP and TGF-beta as airway inflammatory markers in induced sputum as well as mRNA and miRNA expression levels of IL-6, IL-8, IL-17, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta as airway inflammatory markers in nasal mucosa. The secondary objective includes the analyses of the measurement characteristics of inflammation cell profiles, LTB4 and protein levels of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta, ECP and TGF-beta.
Twenty COPD patients with an initial COPD exacerbation will be followed for a period of seven weeks for three consecutive visits
The main parameters of induced sputum samples will be mRNA level expression of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta. The main parameters of nasal mucosa samples will be mRNA and miRNA level expression of IL-6, IL-8, IL-17, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta.
To allow for full perspective on the outcomes, inflammatory cell profiles, Leukotriene B4 (LTB4) and protein levels of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta, eosinophilic cationic protein (ECP) and TGF-beta in sputum will be assessed.
- Conditions
- COPD, COPD Exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mRNA cytokine expression measured in induced sputum samples
mRNA level expression of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta
Measured: Change of outcome measures will be assessed during one COPD exacerbation phase, after 42 days and after 44-51 days
Change of miRNA and mRNA cytokine expression measured in nose mucosa samples
mRNA and miRNA level expression of IL-6, IL-8, IL-17, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta
Measured: Change of outcome measures will be assessed during one COPD exacerbation phase, after 42 days and after 44-51 days
Secondary outcomes (1)
Change of inflammatory cell profiles, LTB4 levels and protein cytokine levels measured in induced sputum samples
Inflammatory cell profiles; LTB4 levels; protein levels of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta, ECP and TGF-beta
Measured: Change of outcome measures will be assessed during one COPD exacerbation phase, after 42 days and after 44-51 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start14 Nov 2017
- Primary completion27 Feb 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huib A.M. Kerstjens, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924843
- Sponsor's protocol ID
- NL 62038.042.17
- Status last verified
- Jul 2021
- First submitted
- 6 Mar 2019
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bathoorn E, Liesker J, Postma D, Koeter G, van Oosterhout AJ, Kerstjens HA. Safety of sputum induction during exacerbations of COPD. Chest. 2007 Feb;131(2):432-8. doi: 10.1378/chest.06-2216.
PubMed 17296644Brightling CE, Monterio W, Green RH, Parker D, Morgan MD, Wardlaw AJ, Pavord D. Induced sputum and other outcome measures in chronic obstructive pulmonary disease: safety and repeatability. Respir Med. 2001 Dec;95(12):999-1002. doi: 10.1053/rmed.2001.1195.
PubMed 11778799Comer DM, Elborn JS, Ennis M. Comparison of nasal and bronchial epithelial cells obtained from patients with COPD. PLoS One. 2012;7(3):e32924. doi: 10.1371/journal.pone.0032924. Epub 2012 Mar 6.
PubMed 22412951Hogg JC, Chu F, Utokaparch S, Woods R, Elliott WM, Buzatu L, Cherniack RM, Rogers RM, Sciurba FC, Coxson HO, Pare PD. The nature of small-airway obstruction in chronic obstructive pulmonary disease. N Engl J Med. 2004 Jun 24;350(26):2645-53. doi: 10.1056/NEJMoa032158.
PubMed 15215480Huang CC, Wang CH, Fu CH, Huang CC, Chang PH, Chen YW, Wu CC, Wu PW, Lee TJ. Association between cigarette smoking and interleukin-17A expression in nasal tissues of patients with chronic rhinosinusitis and asthma. Medicine (Baltimore). 2016 Nov;95(47):e5432. doi: 10.1097/MD.0000000000005432.
PubMed 27893686Kistemaker LE, Oenema TA, Meurs H, Gosens R. Regulation of airway inflammation and remodeling by muscarinic receptors: perspectives on anticholinergic therapy in asthma and COPD. Life Sci. 2012 Nov 27;91(21-22):1126-33. doi: 10.1016/j.lfs.2012.02.021. Epub 2012 Mar 3.
PubMed 22406302O'Donnell RA, Peebles C, Ward JA, Daraker A, Angco G, Broberg P, Pierrou S, Lund J, Holgate ST, Davies DE, Delany DJ, Wilson SJ, Djukanovic R. Relationship between peripheral airway dysfunction, airway obstruction, and neutrophilic inflammation in COPD. Thorax. 2004 Oct;59(10):837-42. doi: 10.1136/thx.2003.019349.
PubMed 15454648Perng DW, Tao CW, Su KC, Tsai CC, Liu LY, Lee YC. Anti-inflammatory effects of salmeterol/fluticasone, tiotropium/fluticasone or tiotropium in COPD. Eur Respir J. 2009 Apr;33(4):778-84. doi: 10.1183/09031936.00115308. Epub 2009 Jan 7.
PubMed 19129278Powrie DJ, Wilkinson TM, Donaldson GC, Jones P, Scrine K, Viel K, Kesten S, Wedzicha JA. Effect of tiotropium on sputum and serum inflammatory markers and exacerbations in COPD. Eur Respir J. 2007 Sep;30(3):472-8. doi: 10.1183/09031936.00023907. Epub 2007 May 15.
PubMed 17504798Rutgers SR, Postma DS, ten Hacken NH, Kauffman HF, van Der Mark TW, Koeter GH, Timens W. Ongoing airway inflammation in patients with COPD who Do not currently smoke. Chest. 2000 May;117(5 Suppl 1):262S. doi: 10.1378/chest.117.5_suppl_1.262s. No abstract available.
PubMed 10843943Singh D, Edwards L, Tal-Singer R, Rennard S. Sputum neutrophils as a biomarker in COPD: findings from the ECLIPSE study. Respir Res. 2010 Jun 15;11(1):77. doi: 10.1186/1465-9921-11-77.
PubMed 20550701Wessler I, Kirkpatrick CJ. Acetylcholine beyond neurons: the non-neuronal cholinergic system in humans. Br J Pharmacol. 2008 Aug;154(8):1558-71. doi: 10.1038/bjp.2008.185. Epub 2008 May 26.
PubMed 18500366Zhang X, Sebastiani P, Liu G, Schembri F, Zhang X, Dumas YM, Langer EM, Alekseyev Y, O'Connor GT, Brooks DR, Lenburg ME, Spira A. Similarities and differences between smoking-related gene expression in nasal and bronchial epithelium. Physiol Genomics. 2010 Mar 3;41(1):1-8. doi: 10.1152/physiolgenomics.00167.2009. Epub 2009 Dec 1.
PubMed 19952278
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsivity and Reproducibility of Messenger and Micro RNA Airway Inflammatory Markers - a Pilot Study
- ClinicalTrials.gov ID
- NCT03924843
- Acronym / sponsor ID
- NL 62038.042.17
- Conditions
- COPD, COPD Exacerbation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 23 Apr 2019 (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 study investigates cytokine Messenger (mRNA) and microRNA (miRNA) level expression of interleukin (IL) -6, IL-8, IL-17, tumor necrosis factor (TNF)-alpha, monocyte chemoattractant protein (MCP)-1, macrophage inflammatory protein (MIP)-1 beta and transforming growth factor (TGF)-beta regarding their reproducibility and responsivity in induced sputum and nasal mucosa of patients with chronic obstructive pulmonary disease (COPD) in order to assess their potential as a biomarker outcome measure.
Detailed description
Rationale:There is an increased interest to identify sensitive airway biomarkers in order to evaluate the potential and efficacy of anti-inflammatory and -remodelling therapeutic interventions. Biomarkers should be easily obtainable, reliable and valid. In COPD, easily obtainable would suggest use of blood, or more directly associated with the airways: sputum or epithelial brushes. Sputum is an obvious opportunity. It has been shown that gene expression changes in the nasal mucosa might be used as suitable surrogate for epithelial cells of the lower airways in patients with airway inflammatory diseases. However, further studies are needed to validate these assumptions. Measurement of messenger RNA, and of micro RNA derived from sputum samples and nasal brushes would fulfil the ease of use required of a biomarker. Messenger RNA would allow for easier quantification in variable dilution samples (sputum). The Groningen Research Institute for Asthma and COPD (GRIAC research group) has experience with sputum and nasal brushes, mRNA and miRNA, but more information is needed on especially reproducibility of the measurements, as well as on responsivity. Both are a prerequisite when designing new intervention trials with such biomarkers.
Therefore, the aim of this study is to investigate cytokine messenger and microRNA level expression of IL-6, IL-8, IL-17, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta regarding their reproducibility and responsivity in induced sputum and nasal mucosa of COPD patients in order to assess their potential as an objective outcome measure.
The primary objectives of this prospective pilot study are the determination of the reproducibility and responsivity of mRNA level expression of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta, ECP and TGF-beta as airway inflammatory markers in induced sputum as well as mRNA and miRNA expression levels of IL-6, IL-8, IL-17, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta as airway inflammatory markers in nasal mucosa. The secondary objective includes the analyses of the measurement characteristics of inflammation cell profiles, LTB4 and protein levels of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta, ECP and TGF-beta.
Twenty COPD patients with an initial COPD exacerbation will be followed for a period of seven weeks for three consecutive visits
The main parameters of induced sputum samples will be mRNA level expression of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta. The main parameters of nasal mucosa samples will be mRNA and miRNA level expression of IL-6, IL-8, IL-17, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta.
To allow for full perspective on the outcomes, inflammatory cell profiles, Leukotriene B4 (LTB4) and protein levels of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta, eosinophilic cationic protein (ECP) and TGF-beta in sputum will be assessed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Twenty COPD patients with an initial COPD exacerbation will be followed for a period of seven weeks for three consecutive visits
Key inclusion criteria (6 listed)
- Men/Women age >40 years.
- Diagnoses of COPD according to criteria of the American Thoracic Society (ATS), a disease state characterized by the presence of chronic airway obstruction due to chronic bronchitis (cough/sputum on most days a week for 3 months in a year for at least two successive years) and/or emphysema
- Diagnosis of moderate or severe COPD exacerbation (see "Definitions")
- FEV1 > 0.8 L and ability to produce sputum after hypertonic saline production
- Post bronchodilator FEV1/Forced Vital Capacity (FVC) ratio <70 % and post bronchodilator FEV1< 80% pred.
Key exclusion criteria (9 listed)
- Pneumonia as determined by X-ray
- > 48 h intake of prednisolon/antibiotics
- Need for mechanical ventilation (either invasive or non-invasive)
- Treatment with immune-modulating agents for any disease
- Experimental interventions for COPD last half year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of mRNA cytokine expression measured in induced sputum samples
Time frame: Change of outcome measures will be assessed during one COPD exacerbation phase, after 42 days and after 44-51 days
mRNA level expression of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta
Change of miRNA and mRNA cytokine expression measured in nose mucosa samples
Time frame: Change of outcome measures will be assessed during one COPD exacerbation phase, after 42 days and after 44-51 days
mRNA and miRNA level expression of IL-6, IL-8, IL-17, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta
1 secondary outcome
Change of inflammatory cell profiles, LTB4 levels and protein cytokine levels measured in induced sputum samples
Time frame: Change of outcome measures will be assessed during one COPD exacerbation phase, after 42 days and after 44-51 days
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 9 Jul 2021.
- Background: PubMed 17296644Bathoorn E, Liesker J, Postma D, Koeter G, van Oosterhout AJ, Kerstjens HA. Safety of sputum induction during exacerbations of COPD. Chest. 2007 Feb;131(2):432-8. doi: 10.1378/chest.06-2216.
- Background: PubMed 11778799Brightling CE, Monterio W, Green RH, Parker D, Morgan MD, Wardlaw AJ, Pavord D. Induced sputum and other outcome measures in chronic obstructive pulmonary disease: safety and repeatability. Respir Med. 2001 Dec;95(12):999-1002. doi: 10.1053/rmed.2001.1195.
- Background: PubMed 22412951Comer DM, Elborn JS, Ennis M. Comparison of nasal and bronchial epithelial cells obtained from patients with COPD. PLoS One. 2012;7(3):e32924. doi: 10.1371/journal.pone.0032924. Epub 2012 Mar 6.
- Background: PubMed 15215480Hogg JC, Chu F, Utokaparch S, Woods R, Elliott WM, Buzatu L, Cherniack RM, Rogers RM, Sciurba FC, Coxson HO, Pare PD. The nature of small-airway obstruction in chronic obstructive pulmonary disease. N Engl J Med. 2004 Jun 24;350(26):2645-53. doi: 10.1056/NEJMoa032158.
- Background: PubMed 27893686Huang CC, Wang CH, Fu CH, Huang CC, Chang PH, Chen YW, Wu CC, Wu PW, Lee TJ. Association between cigarette smoking and interleukin-17A expression in nasal tissues of patients with chronic rhinosinusitis and asthma. Medicine (Baltimore). 2016 Nov;95(47):e5432. doi: 10.1097/MD.0000000000005432.
- Background: PubMed 22406302Kistemaker LE, Oenema TA, Meurs H, Gosens R. Regulation of airway inflammation and remodeling by muscarinic receptors: perspectives on anticholinergic therapy in asthma and COPD. Life Sci. 2012 Nov 27;91(21-22):1126-33. doi: 10.1016/j.lfs.2012.02.021. Epub 2012 Mar 3.
- Background: PubMed 15454648O'Donnell RA, Peebles C, Ward JA, Daraker A, Angco G, Broberg P, Pierrou S, Lund J, Holgate ST, Davies DE, Delany DJ, Wilson SJ, Djukanovic R. Relationship between peripheral airway dysfunction, airway obstruction, and neutrophilic inflammation in COPD. Thorax. 2004 Oct;59(10):837-42. doi: 10.1136/thx.2003.019349.
- Background: PubMed 19129278Perng DW, Tao CW, Su KC, Tsai CC, Liu LY, Lee YC. Anti-inflammatory effects of salmeterol/fluticasone, tiotropium/fluticasone or tiotropium in COPD. Eur Respir J. 2009 Apr;33(4):778-84. doi: 10.1183/09031936.00115308. Epub 2009 Jan 7.
- Background: PubMed 17504798Powrie DJ, Wilkinson TM, Donaldson GC, Jones P, Scrine K, Viel K, Kesten S, Wedzicha JA. Effect of tiotropium on sputum and serum inflammatory markers and exacerbations in COPD. Eur Respir J. 2007 Sep;30(3):472-8. doi: 10.1183/09031936.00023907. Epub 2007 May 15.
- Background: PubMed 10843943Rutgers SR, Postma DS, ten Hacken NH, Kauffman HF, van Der Mark TW, Koeter GH, Timens W. Ongoing airway inflammation in patients with COPD who Do not currently smoke. Chest. 2000 May;117(5 Suppl 1):262S. doi: 10.1378/chest.117.5_suppl_1.262s. No abstract available.
- Background: PubMed 20550701Singh D, Edwards L, Tal-Singer R, Rennard S. Sputum neutrophils as a biomarker in COPD: findings from the ECLIPSE study. Respir Res. 2010 Jun 15;11(1):77. doi: 10.1186/1465-9921-11-77.
- Background: PubMed 18500366Wessler I, Kirkpatrick CJ. Acetylcholine beyond neurons: the non-neuronal cholinergic system in humans. Br J Pharmacol. 2008 Aug;154(8):1558-71. doi: 10.1038/bjp.2008.185. Epub 2008 May 26.
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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?
An observational study of COPD and COPD Exacerbation, run by University Medical Center Groningen at 1 site in Netherlands.
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 9 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 9 Jul 2021. 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 Netherlands. 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.
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?
Change of mRNA cytokine expression measured in induced sputum samples (time frame: Change of outcome measures will be assessed during one COPD exacerbation phase, after 42 days and after 44-51 days). The study lists 2 primary outcomes in all. 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 NCT03924843, which also lists 13 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 9 Jul 2021.