An observational study in COPD, Quality of Life and Mental Health, sponsored by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara. Completed at 1 site in Romania. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara · Observational
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Among 103 studies in Pulmonary Disease, Chronic Obstructive with a site in Romania — 9 open to participants now, 12 under way, 5 of them phase 3. Pulmonary Disease, Chronic Obstructive · Romania.
Among the 103 studies in Pulmonary Disease, Chronic Obstructive with a site in Romania, this one is the 7th largest by enrollment of the 10 observational ones that give a count, is one of 6 that started in 2024, is one of 10 observational ones, and was the 93rd registered.
5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →9 of the 103 studies in Pulmonary Disease, Chronic Obstructive with a site in Romania are open now. Recruiting first, the newest first:
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara · Sites in Romania
Ages 18–100
Eli Lilly and Company · Sites in Romania, United States, Argentina and 15 more countries
Ages 40–75
Sanofi · Sites in Romania, United States, Argentina and 23 more countries
Ages 40–80
GlaxoSmithKline · Sites in Romania, United States, Argentina and 13 more countries
Ages 40–80
AstraZeneca · Sites in Romania, United States, Argentina and 19 more countries
Ages 40–80
A study can be open while its sites in Romania have not opened yet or have stopped. Only those recruiting at a site in Romania →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 88 take healthy volunteers.
This study: 40 Years to 75 Years · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
103 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 6 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 98 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 872 across the 93 interventional studies, 1,253 across the 10 observational. Of the 90 that completed or were terminated, 67 (74%) have results posted.
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98 of 103 have an industry lead sponsor. The 10 most frequent:
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara has 3 studies filed under Pulmonary Disease, Chronic Obstructive — fewer than ten, so there is no comparison to draw.
6 of the studies in Pulmonary Disease, Chronic Obstructive with a site in Romania that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05878769Phase 3Hoffmann-La RocheA Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) | 2027-06-30 |
| NCT06712563AstraZenecaPooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting | 2026-12-14 |
| NCT07108166Philip Morris Products S.A.Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS | 2027-02 |
| NCT07472283University Children's Hospital BaselDesign, Development and Evaluation of a Digital Health Assistant for Paediatric Asthma | 2027-05 |
| NCT07786220Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș TimișoaraCognitive Load and Inhaler Technique in COPD | 2027-09-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 103 studies in Pulmonary Disease, Chronic Obstructive with a site in Romania, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Chronic obstructive pulmonary disease (COPD) can significantly impact a person's quality of life, not only physically but also mentally. This cross-sectional study aims to assess the psychological well-being of COPD patients by utilising specific questionnaires. These questionnaires will evaluate various aspects of mental health, including anxiety, depression, and potentially other relevant factors like self-compassion or fear of negative evaluation, self-efficacy, shame, and guilt. Additionally, the study will examine how these psychological factors relate to the severity of COPD symptoms, such as dyspnea and functional limitations. By understanding the psychological impact of COPD, this research hopes to emphasize the importance of medical education and mental health support in COPD management strategies.
Chronic obstructive pulmonary disease (COPD) profoundly impacts both physical health and quality of life. Beyond the challenges of breathlessness and functional limitations, COPD patients often struggle with anxiety, depression, and other mental health difficulties at a much higher rate than the general population. This cross-sectional study seeks to understand the current state of psychological well-being in patients with COPD and explore how it relates to the severity of their condition. the study aims to assess the psychological well-being of COPD patients by utilizing specific questionnaires. These questionnaires will evaluate various aspects of mental health, including anxiety, depression, and potentially other relevant factors like self-compassion or fear of negative evaluation, self-efficacy, shame, and guilt. Additionally, the study will examine how these psychological factors relate to the severity of COPD symptoms, such as dyspnea and functional limitations. Investigators will use the following tests:
Individuals with COPD post-bronchodilator spirometry demonstrating airflow obstruction (FEV1/FVC \< 0.70) following GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnosis of COPD established by a qualified healthcare professional (e.g., pulmonologist, general practitioner) based on: Post-bronchodilator spirometry demonstrating airflow obstruction (FEV1/FVC \< 0.70) following GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines. Age: 18 years or older. Adequate visual and/or auditory abilities to read and understand study materials/questionnaires or receive instructions verbally
Other: COPD psychological well-being assessment
Patients will complete the following questionnaires: Hospital Anxiety and Depression Scale (HADS), COPD Assessment Test (CAT), State Shame and Guilt Scale (SSGS), Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE), Brief Fear of Negative Evaluation Scale (BFNE), Self-Compassion Scale Short Form (SCS-SF). Dyspnea will be evaluated with the mMRC scale, and functional capacity will be assessed with the six-minute walking test (6MWT).
Anxiety and depression assessment
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire used to identify and measure the severity of anxiety and depression symptoms. It has 14 questions, divided into seven questions assessing anxiety (HADS-A) and seven questions assessing depression (HADS-D). Each question has a 4-point response scale (0-3). Scores of 0-7: normal, scores of 8-10: suggestive of anxiety or depression, and scores of 11+ indicate probable presence of anxiety or depression.
Time frame: At inclusion
Impact of COPD
The COPD Assessment Test (CAT) is a questionnaire designed to measure the impact of COPD on a person's well-being. It consists of 8 simple questions. Each question has a 6-point scale (0-5) for the patient to rate their experience. Total scores range from 0 to 40. Higher scores indicate a greater negative impact of COPD on a person's life.
Time frame: At inclusion
Shame and guilt assessment
The State Shame and Guilt Scale (SSGS) is a self-report questionnaire that measures a person's shame and guilt. It has 15 questions in total, divided into three subscales: shame (5 questions), guilt (5 questions), and pride (5 questions), which measures the opposite of shame and guilt. Each item has a 5-point Likert scale ranging from 1 (not feeling in this way) to 5 (feeling this way very strongly). Higher scores on each subscale mean individuals experience those feelings more strongly in the moment.
Time frame: At inclusion
Self-efficacy assessment
The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) is a questionnaire designed to measure a patient's self-efficacy in managing their chronic respiratory disease, particularly within the context of pulmonary rehabilitation. It has 12 questions focused on managing breathlessness, staying physically active, and coping with emotional challenges due to respiratory disease. Patients rate their confidence on a scale of 1 to 10. Higher scores indicate greater self-efficacy.
Time frame: At inclusion
Fear of negative evaluation assessment
The Brief Fear of Negative Evaluation Scale (BFNE) is a psychological tool used to assess an individual's anxiety around being judged or criticized by others. It consists of 12 items. Statements capture different aspects of fear of negative evaluation. The scale uses a Likert scale response format (e.g., 1 = Not at all characteristic of me, 5 = Extremely characteristic of me). Scores are calculated by summing the responses to each item. Higher scores indicate a greater fear of negative evaluation.
Time frame: At inclusion
Self-compassion assessment
The Self-Compassion Scale Short Form (SCS-SF) is designed to measure key components of self-compassion. It consists of 12 items. Two items measure each of the six aspects of self-compassion: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. It uses a 5-point Likert scale (1 = almost never to 5 = almost always). A total self-compassion score is calculated. Higher scores indicate greater self-compassion.
Time frame: At inclusion
Dyspnea assessment
The mMRC scale is a simple questionnaire that grades a patient's level of breathlessness (dyspnea) in everyday life. It has five grades (0-4). The patient selects the statement that best aligns with their experience of breathlessness. Higher scores on the mMRC scale correlate to an increased level of disability for the patient due to breathlessness.
Time frame: At inclusion
Aerobic capacity assessment
The six-minute walking test (6MWT) measures how far a person can walk on a flat, hard surface in six minutes. It is used to assess aerobic capacity and functional endurance (how well the body can handle activity). The distance walked in 6 minutes is compared with predicted values based on age, gender, and height. A shorter walking distance indicates a lower level of functional exercise capacity.
Time frame: At inclusion
Ran from May 2024 to primary completion in Oct 2024, 5 months.
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara