An observational study in Chronic Respiratory Diseases, Cystic Fibrosis and Lymphangioleiomyomatosis, sponsored by I.M. Sechenov First Moscow State Medical University. Enrolling by invitation at 1 site in Russian Federation. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by I.M. Sechenov First Moscow State Medical University · Observational
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Among 13 studies in Cystic Fibrosis with a site in Russian Federation — 1 open to participants now, 1 under way, none of them phase 3. Cystic Fibrosis · Russian Federation.
Among the 13 studies in Cystic Fibrosis with a site in Russian Federation, this one is the only one that started in 2023, is the only observational one, and was the 13th registered.
1,621 studies on the registry are indexed under Cystic Fibrosis; 201 are open to participants now.
Browse Cystic Fibrosis studies →1 of the 13 studies in Cystic Fibrosis with a site in Russian Federation is open now.
A study can be open while its sites in Russian Federation have not opened yet or have stopped. Only those recruiting at a site in Russian Federation →
Of the 156 Cystic Fibrosis studies recruiting now, 95 (61%) set no upper age limit and 45 (29%) stop at 75 or younger; 86 take children under 18; 41 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 400 is above the median of 85 across 503 observational studies indexed under Cystic Fibrosis.
Median enrollment 81 across the 12 interventional studies, 400 across the 1 observational. Of the 12 that completed or were terminated, 11 (92%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 13 have an industry lead sponsor. The 9 most frequent:
I.M. Sechenov First Moscow State Medical University is the lead sponsor of 137 studies on the registry; 28 are open to participants now.
I.M. Sechenov First Moscow State Medical University has 1 study filed under Cystic Fibrosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Cystic Fibrosis with a site in Russian Federation, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Assessment of cardiovascular disorders using echocardiography and arterial stiffness; comparative noninvasive assessment of volatile organic compound (eVOC) exhale breath patterns in patients with different chronic respiratory diseases with age and gender-matched healthy adults in order to identify a disease-specific exhaled eVOCs profiles and markers of respiratory and cardiovascular disorders.
Evaluating of eVOCs profiles by proton mass spectrometry with a time-of-flight (PTR-TOF) in patients with different chronic respiratory diseases is of great interest for assessing the prognosis and development of severe ventilation and cardiovascular disorders.
The aim of our study is to determine the diagnostic significance of PTR-TOF analysis in patients with chronic respiratory diseases and to identify specific eVOC markers of a severe ventilation and cardiovascular disorders in patients with different chronic respiratory diseases.
The study population consists of all males and females over 18 years old in the community according to inclusion, non-inclusion, and exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Included patients, aged ≥ 18 years, with chronic respiratory diseases: COPD, bronchial asthma, cystic fibrosis, lymphangioleiomyomatosis, hypersensitivity pneumonitis and other interstitial lung diseases. Intervention: breath analysis using the Compact PTR-MS proton mass spectrometer by Ionicon (Austria); electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"; assessment of arterial stiffness using the VaSera VS-1500N Fukuda Denshi device by non-invasive measurement of blood pressure in four limbs with simultaneous recording of electrocardiogram (ECG), phonocardiogram (PCG) and pulse waves on the carotid, femoral arteries, as well as on the arteries of four limbs. Interventions: Diagnostic Test: Breath analysis using the Compact PTR-MS proton mass spectrometer; Diagnostic Test: Portable cardiac monitor "CardioQvark"; Diagnostic Test: Assessment of arterial stiffness using the VaSera VS-1500N.
Diagnostic Test: Breath test using the Compact PTR-TOF-MS · Diagnostic Test: Portable cardiac monitor "CardioQvark" · Diagnostic Test: Assessment of arterial stiffness using the VaSera VS-1500N
Included subjects, aged ≥ 18 years. Intervention: breath analysis using the Compact PTR-MS proton mass spectrometer by Ionicon (Austria); electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"; assessment of arterial stiffness using the VaSera VS-1500N Fukuda Denshi device by non-invasive measurement of blood pressure in four limbs with simultaneous recording of ECG, phonocardiogram (PCG) and pulse waves on the carotid, femoral arteries, as well as on the arteries of four limbs. Interventions: Diagnostic Test: Breath analysis using the Compact PTR-MS proton mass spectrometer; Diagnostic Test: Portable cardiac monitor "CardioQvark"; Diagnostic Test: Assessment of arterial stiffness using the VaSera VS-1500N.
Diagnostic Test: Breath test using the Compact PTR-TOF-MS · Diagnostic Test: Portable cardiac monitor "CardioQvark" · Diagnostic Test: Assessment of arterial stiffness using the VaSera VS-1500N
Breath samples will be analyzed with a proton-transfer reaction mass spectrometer (Compact PTR-MS, Ionicon, Austria) to obtain eVOCs profiles listed as ions at various mass-to-charge ratios (m/z).
Record an electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark" (Russia, LLC "L Card" , RU No. RZN 2019/8124 dated February 15, 2019) once. Devices automatically transfer data to the A\&D Connect app paired with it (link). When transferring data, they are completely protected. The data obtained using the application must be sent to the specialists of the research group in a depersonalized form.
Assessment of arterial stiffness using the VaSera VS-1500N Fukuda Denshi device by non-invasive measurement of blood pressure in four limbs with simultaneous recording of ECG, PCG and pulse waves on the carotid, femoral arteries, as well as on the arteries of four limbs.
Molecular composition of exhaled breath analysed by proton-transfer reaction mass spectrometer (Compact PTR-MS, Ionicon, Austria)
Exhaled volatile organic compounds (eVOCs) profiles listed as ions at various mass-to-charge ratios (m/z)
Time frame: up to 3 years
Results of recording an electrocardiogram (ECG) in one lead with an assessment of the pulse wave
Pulse wave velocity, augmentation index, pulse wave type (A, B or C) analysed by a portable cardiac monitor "CardioQvark"
Time frame: up to 3 years
Indicators of arterial stiffness
Cardio-ankle vascular index and ankle-brachial index analysed with using the VaSera VS-1500N
Time frame: up to 3 years
Composite of clinical records
Clinical data are assessed via questionaire according to the Modified Medical Research Council (mMRC) Dyspnea Scale (scale points: 0 scores - the best outcome, 4 scores - the worst outcome) and Borg Dyspnea scale (scale points: 1 score - the best outcome, 10 scores - thr worst outcome), Standard examination of respiratory function (spirometry: FVC, FEV1, FEV1/FVC, FEF75 - % of predicted, absolute value, z-score; body plethysmography: TLC, RV, VC - % of predicted, absolute value, z-score; diffusion test: DLCO, DLCO/VA - % of predicted, absolute value, z-score), echocardiography, CT scan of the chest, if necessary, sputum culture results
Time frame: up to 3 years
Started Jan 2023 (actual). Primary completion is estimated for Jan 2025, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
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I.M. Sechenov First Moscow State Medical University →