An observational study in Bronchiectasis and Respiratory Disease, sponsored by Universidad San Jorge. Withdrawn at 1 site in Spain. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-31.
Sponsored by Universidad San Jorge · Observational
Among 39 studies in Bronchiectasis with a site in Spain — 9 open to participants now, 11 under way, 3 of them phase 3. Bronchiectasis · Spain.
Among the 39 studies in Bronchiectasis with a site in Spain, this one is one of 4 that started in 2017, is one of 6 observational ones, and was the 18th registered.
404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.
Browse Bronchiectasis studies →9 of the 39 studies in Bronchiectasis with a site in Spain are open now. Recruiting first, the newest first:
Corporacion Parc Tauli · Sites in Spain
Ages 5–18
AstraZeneca · Sites in Spain, United States, Argentina and 22 more countries
Ages 12+
GlaxoSmithKline · Sites in Spain, United States, Argentina and 9 more countries
Ages 18–85
Boehringer Ingelheim · Sites in Spain, United States, Argentina and 43 more countries
Ages 12+
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA · Sites in Spain, United States, Italy and 1 more country
Ages 18–80
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 93 Bronchiectasis studies recruiting now, 50 (54%) set no upper age limit and 13 (14%) stop at 75 or younger; 12 take children under 18; 26 take healthy volunteers.
This study: 18 Years to 90 Years · 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.
39 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 4 started in 2017.
Median enrollment 107 across the 33 interventional studies, 73 across the 6 observational. Of the 23 that completed or were terminated, 11 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 39 have an industry lead sponsor. The 10 most frequent:
Universidad San Jorge is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Universidad San Jorge has 3 studies filed under Bronchiectasis — fewer than ten, so there is no comparison to draw.
5 of the studies in Bronchiectasis with a site in Spain that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06443658Phase 3Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaBenefits of Inhalation of Hypertonic Saline Solution Prior to Physiotherapy ELTGOL Technique in Bronchiectasis | 2027-02 |
| NCT06872892Phase 3Boehringer IngelheimThe AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis | 2027-06-15 |
| NCT05846230Boehringer IngelheimClairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine | 2027-03-31 |
| NCT07201051GlaxoSmithKlineA Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis | 2027-05-04 |
| NCT06559150Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USAA Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis | 2027-09-24 |
Add all 5 to your calendar (.ics) → With an account.
Among the 39 studies in Bronchiectasis with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Pain mechanisms and their clinical impact in patients with bronchiectasis have not been investigated yet. The aim of the research is to assess the presence of central pain mechanisms in patients with bronchiectasis using the Quantitative Sensory Testing (QST) assumptions.
Background and objective:
Recent findings suggest that pain can play an important role in terms of physical activity limitation in respiratory patients. Nevertheless, pain mechanisms and their clinical impact in patients with bronchiectasis have not been investigated yet. The objective of the observational study is to determine the somatosensorial profile in order to assess the presence of central pain mechanisms in patients with bronchiectasis.
Methodology:
Repeated-measures prospective cross-sectional study. A sample of patients diagnosed with bronchiectasis will be recruited and matched by age and sex with healthy controls. Pressure pain thresholds (PPTs), conditioned pain modulation (CPM) and referral pain will be assessed before and after the Incremental Shuttle Walking test (ISW). Levels of physical activity will be assessed using accelerometry during a 7-days period. Sleep quality (Pittsburgh sleep quality test), level of catastrophizing (Pain Catastrophizing Scale), level of sensitization (Central Sensitization Inventory) and level of anxiety and depression (Hospital Anxiety and Depression) will be assessed. The assessments will be done twice: 1) at baseline; and 2) at 6 months follow-up period.
Adult patients diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase.
Bronchiectasis Group
Inclusion Criteria:
Exclusion Criteria:
Control Group
Inclusion Criteria:
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.
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.
Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase, matched by by sex and age with healthy subjects.
Other: No intervention
No intervention
Referred pain area
Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
Time frame: Baseline
Number of body areas affected by referred pain
Body chart is divided in 15 regions and the frequency of pain in each one is registered after STPS
Time frame: Baseline
Pain intensity after supra threshold pain stimulus (STPS)
Level of pain in a visual analogue scale from 0 to 10 after STPS
Time frame: Baseline
Pressure pain thresholds (PPTs)
Level of pressure tolerated by the patient just before feel pain. The pressure is done with an algometer (SB-MEDIC Electronics, Solna, Sweden). PPTS will be assessed bilaterally in infraspinatus, supraspinatus and medial gastrocnemius muscles.
Time frame: Baseline
PPTs with a Conditioned Pain Modulation (CPM) pressure stimulus
Level of pressure tolerated by patient just before feel pain. The conditionated pressure stimulus is preform by a blood pressure cuff. CPM will be assessed bilaterally in infraspinatus, supraspinatus and medial gastrocnemius muscles.
Time frame: Baseline
Total physical activity time
Total time spent per day in physical activities at different intensities equal or superior to 100 counts per minute (≥100 cpm), obtained by accelerometry (Actigraph gt3x+).
Time frame: 7 days period
Sedentary behaviour time
Total time spent per day in physical activities at different intensities inferior to 100 cpm (\<100 cpm).
Time frame: 7 days period
Light physical activity time
Total time spent per day in physical activities at intensities between 100 and 1951 cpm (100-1951 cpm).
Time frame: 7 days period
Moderate-Vigorous physical activity time
Total time spent per day in physical activities at intensities equal or superior to 1952 cpm (≥1952 cpm).
Time frame: 7 days period
Level of catastrophizing
Punctuation obtained in Pain Catastrophizing Scale (PCS). It comprises 13 items which focus on thoughts and feelings encountered while experiencing pain. Each item is scored from 0 (not at all) to 4 (all the time) with a total PCS score range from 0-52 points, where higher scores indicating higher levels of pain catastrophizing.
Time frame: Baseline
Level of sensitization
Punctuation obtained in Central Sensitization Inventory (CSI). CSI assesses 25 health-related symptoms common to Central Sensitivity Syndromes. Responses are recorded about the frequency of each symptom, with a Likert scale from 0 (never) to 4 (always), resulting in a total possible score of 100. Higher scores are associated with a higher degree of self-reported symptomology.
Time frame: Baseline
Level of anxiety and depression
Punctuation obtained in Hospital Anxiety and Depression (HAD). The HAD is a 14-item self-report scale measuring the presence of symptoms of both anxiety (seven items) and depression (seven items) during the past week. Each item is scored from 0 to 3, so the final score for each subscale is between 0 and 21. The majority of the studies use the cutoffs of 7/8 for possible and 10/11 for probable anxiety or depression.
Time frame: Baseline
Quality of sleep
Punctuation obtained in Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. Each sleep component yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. Sleep component scores were summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Time frame: Baseline
Level of resilience
Punctuation obtained in Brief Resilience Scale (BRS). This is a 6-item self-report scale with a 5-point response scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher score indicates a higher degree of resilience.
Time frame: Baseline
Distance in ISW test
Meters reached in the ISW test.
Time frame: Baseline
Changes in referred pain area
Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
Time frame: Baseline and after 6 months follow-up
Changes in number of body areas affected by referred pain
Body chart is divided in 15 regions and the frequency of pain in each one is registered after STPS
Time frame: Baseline and after 6 months follow-up
Changes in pain intensity after supra threshold pain stimulus (STPS)
Level of pain in a visual analogue scale from 0 to 10 after STPS.
Time frame: Baseline and after 6 months follow-up
Changes in pressure pain thresholds (PPTs)
Level of pressure tolerated by the patient just before feel pain. The pressure is done with an algometer (SB-MEDIC Electronics, Solna, Sweden)
Time frame: Baseline and after 6 months follow-up
Changes in Pressure Pain Thresholds (PPTs) with a Conditioned Pain Modulation (CPM) pressure stimulus
Level of pressure tolerated by patient just before feel pain. The conditionated pressure stimulus is preform by a blood pressure cuff
Time frame: Baseline and after 6 months follow-up
Started Sep 2017 (actual). Primary completion is estimated for Oct 2019, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Universidad San Jorge