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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001435-13 | EudraCT Number |
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Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the world and further increase in its prevalence and mortality has been predicted. Currently, the main long-term treatments are the long-acting beta-2 agonist, indacaterol, salmeterol and the anticholinergic drug, tiotropium and glycopyrronium, used alone or in combination:
These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®, Handihaler® and Diskus®.
The correct use of inhaler devices is an inclusion criterion in COPD clinical trials. In real life, patients may make many errors using their own inhaler device, which may alter the positive effects observed in clinical trials.
The main objective of this study is to describe the handling of inhaler devices (indacaterol-glycopyrronium Breezhaler®, tiotropium Respimat® and salmeterol-fluticasone Diskus®) in patients with COPD.
All participants will receive each of the three treatments (Seretide® Diskus® 500/550 μg, Ultibro® Breezhaler® 110/50 μg and Spiriva® Respimat® 2,5 μg). Each treatment will be given daily for one week, followed by a 7-day washout period.
On day 1 of each treatment period, the patient will have clinical examination, lung function testing (FEV1) and 2 video recordings:
At the end of the visit, the patient will watch a standardized video demonstrating correct inhaler technique.
On day 7 of each treatment period, the patient will have clinical examination, lung function testing (FEV1) and 1 video recording of inhaler device use (one puff).
30 days after the last visit, the patient will have a phone contact to collect the adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
| |
| Group 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seretide® Diskus® 500/550 μg | Drug | Every day during 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the presence of at least a major error in the use of the inhalation system, from standardized checklist | Day 7 of each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of non critical errors from standardized checklist | Day 7 of each treatment | |
| Number of non device-dependant errors from standardized checklist | Day 7 of each treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hélène PEYROUZET, Dr | Service Hospitalo-Universitaire de Pharmacologie Médicale | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC-P - Centre François Magendie - G3 - Hôpital Haut-Lévêque | Bordeaux | 33604 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30446655 | Result | Kocks JWH, Chrystyn H, van der Palen J, Thomas M, Yates L, Landis SH, Driessen MT, Gokhale M, Sharma R, Molimard M. Systematic review of association between critical errors in inhalation and health outcomes in asthma and COPD. NPJ Prim Care Respir Med. 2018 Nov 16;28(1):43. doi: 10.1038/s41533-018-0110-x. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Ultibro® Breezhaler® 110/50 μg | Drug | Every day during 7 days |
|
| Spiriva® Respimat® 2,5 μg | Drug | Every day during 7 days |
|
| Measure of the time necessary for drug administration |
Time in second |
| Up to day 7 of each treatment |
| Measure of Forced Expiratory Volume in 1 second (FEV1) | At baseline and at day 7 |
| Collection of adverse events | Up to day 66 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |