An interventional study of Working-Memory Cognitive Load During Inhaler Use and Single-Task Inhaler Use in COPD, sponsored by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara. Recruiting at 1 site in Romania. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara · Not applicable, Interventional, and Other
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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 89th largest by planned enrollment of the 93 interventional ones that give a count, is one of 3 that started in 2026, is one of 4 with no phase, reaches primary completion later than 5 of the 11 other live ones, and was the 103rd 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:
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
Heart Care Foundation · Sites in Romania, Bulgaria, Denmark and 3 more countries
Ages 65+
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: 18 Years to 100 Years · all sexes · no healthy volunteers.
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103 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 62 across 3,840 interventional 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.
This study evaluates whether cognitive load affects inhaler technique in adults with chronic obstructive pulmonary disease (COPD). During a single study visit, participants will complete assessments of cognitive function, mobility, and respiratory status. Dual-task mobility will be assessed using the Timed Up and Go test performed alone and while completing a cognitive task. Inhaler technique will then be evaluated in two conditions: usual inhaler use without an additional task and inhaler use while maintaining a short sequence of digits in working memory. Inhaler technique will be scored using a standardized five-step device-specific checklist, and inhaler use time will also be recorded. The study will examine whether inhaler technique worsens under cognitive load and whether this deterioration is associated with dual-task mobility performance, cognitive function, respiratory symptoms, and functional capacity. No inhaler training or correction will be provided between the two inhaler conditions. All assessments are performed during a single visit.
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.
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.
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.
Participants first perform inhaler use under the single-task condition, without a concurrent cognitive task. After a short rest and without any inhaler-technique training or correction, they perform inhaler use under a working-memory cognitive load. In both conditions, inhaler technique is scored using the same standardized five-item device-specific checklist and inhaler-use time is recorded.
Behavioral: Working-Memory Cognitive Load During Inhaler Use · Behavioral: Single-Task Inhaler Use
Participants first perform inhaler use under a working-memory cognitive load. After a short rest and without any inhaler-technique training or correction, they perform inhaler use under the single-task condition without a concurrent cognitive task. In both conditions, inhaler technique is scored using the same standardized five-item device-specific checklist and inhaler-use time is recorded.
Behavioral: Working-Memory Cognitive Load During Inhaler Use · Behavioral: Single-Task Inhaler Use
Participants are presented with a standardized five-digit sequence before inhaler use and are instructed to retain the sequence in working memory while completing their usual inhaler technique. The sequence is presented once at approximately one digit per second. Participants do not verbalize the digits during inhaler use. Immediately after completing the inhaler maneuver, they reproduce the sequence in reverse order. Inhaler technique is simultaneously assessed using a standardized five-item device-specific checklist, and inhaler-use time is recorded.
Participants use their usual maintenance inhaler without a concurrent cognitive task. They are instructed to use the inhaler as they normally do at home. Inhaler technique is assessed using the same standardized five-item device-specific checklist, and inhaler-use time is recorded. No inhaler-technique training, correction, or feedback is provided before completion of both study conditions.
Change in Inhaler Technique Performance Under Cognitive Load
Difference in the number of satisfactory inhaler-technique steps between the cognitive dual-task condition and the single-task condition, assessed using the same standardized 5-item device-specific inhaler technique checklist. Each checklist item is scored as 1 = satisfactory or 0 = unsatisfactory/omitted, yielding a total score of 0 to 5 for each condition. The primary outcome is calculated as dual-task satisfactory score minus single-task satisfactory score, with a possible range from -5 to +5. Negative values indicate deterioration of inhaler technique under cognitive load.
Time frame: During the single study visit, immediately after completion of both inhaler conditions
New Inhaler Error Under Cognitive Load
Binary outcome indicating whether inhaler technique deteriorates under cognitive load. A new inhaler error is defined as having fewer satisfactory items on the standardized 5-item inhaler technique checklist during the cognitive dual-task condition than during the single-task condition. Coded as 1 = deterioration under cognitive load and 0 = no deterioration.
Time frame: During the single study visit, immediately after completion of both inhaler conditions
Worsening of Inhaler Technique Classification Under Cognitive Load
Binary outcome indicating whether the participant's inhaler technique classification worsens from Acceptable during the single-task condition to Unacceptable during the cognitive dual-task condition. Inhaler technique is classified using the standardized 5-item checklist, with 4-5 satisfactory steps classified as Acceptable and 0-3 satisfactory steps classified as Unacceptable. Coded as 1 = classification worsened and 0 = no worsening.
Time frame: During the single study visit, immediately after completion of both inhaler conditions
Inhaler Time Dual-Task Cost
Percentage change in inhaler-use time between the cognitive dual-task and single-task conditions. It is calculated as \[(dual-task inhaler time - single-task inhaler time) / single-task inhaler time\] × 100. Positive values indicate slower inhaler use under cognitive load.
Time frame: During the single study visit, immediately after completion of both inhaler conditions
Inhaler Cognitive Dual-Task Cost
Percentage change in working-memory performance between the cognitive single-task condition and the inhaler cognitive dual-task condition. It is calculated as \[(single-task cognitive accuracy - dual-task cognitive accuracy) / single-task cognitive accuracy\] × 100. Positive values indicate poorer cognitive performance while using the inhaler under cognitive load.
Time frame: During the single study visit, immediately after completion of the inhaler cognitive assessments
Physical Dual-Task Cost During Timed Up and Go
Percentage increase in Timed Up and Go completion time during the cognitive dual-task condition compared with the single-task condition. It is calculated as \[(TUG dual-task time - TUG single-task time) / TUG single-task time\] × 100. Positive values indicate slower mobility performance during dual-tasking.
Time frame: During the single study visit, immediately after completion of the single-task and dual-task Timed Up and Go assessments
Cognitive Dual-Task Cost During Timed Up and Go
Percentage reduction in cognitive performance during the dual-task Timed Up and Go condition compared with the cognitive single-task condition. Cognitive performance is quantified using the rate of correct responses per second. The outcome is calculated as \[(single-task correct-response rate - dual-task correct-response rate) / single-task correct-response rate\] × 100. Positive values indicate poorer cognitive performance during dual-task walking.
Time frame: During the single study visit, immediately after completion of the cognitive single-task and dual-task Timed Up and Go assessments
Change in Inhaler Completion Time Under Cognitive Load
Absolute difference in inhaler-use time between the cognitive dual-task and single-task conditions. It is calculated as dual-task inhaler time minus single-task inhaler time, expressed in seconds. Positive values indicate longer inhaler-use time under cognitive load.
Time frame: During the single study visit, immediately after completion of both inhaler conditions
Plan to share: No — Individual participant data will not be made publicly available. De-identified data may be provided by the corresponding investigator upon reasonable request, subject to approval by the study team and, where required, the relevant ethics committee and institutional data-protection requirements.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Sep 2027, 13 months after the start.
Of 1,095 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 13 months is below that.
Counting every sponsor, half of 1,182 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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Pulmonary Disease, Chronic Obstructive →
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara