Chronic Obstructive Pulmonary Disease (COPD)Phase 4INTUITIVENCT02813200
Description of the Ability to Learn How to Handle Inhaler Devices in COPD
A Phase 4 study testing Seretide® Diskus® 500/550 μg, Ultibro® Breezhaler® 110/50 μg and Spiriva® Respimat® 2,5 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Seretide® Diskus® 500/550 μg, Ultibro® Breezhaler® 110/50 μg and Spiriva® Respimat® 2,5 μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2017to 8 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged more than 40 years,
- Written informed consent,
- Diagnosis of COPD according to international guidelines (GOLD 2012),
- Social security or health insurance,
- Women of childbearing potential with a very effective contraception according to the Haute Autorité de Santé (HAS) recommendations.
Who cannot join
- Previous treatment with Breezhaler®, Diskus® or Respimat® or similar device,
- QT ≥ 450 ms,
- Contraindications to tiotropium: hypersensitivity to tiotropium,
- Contraindications to indacatérol: hypersensitivity to indacatérol,
- Contraindications to salmeterol: hypersensitivity to salmeterol,
- Contraindications to fluticasone: hypersensitivity to fluticasone,
Show all 14Show fewer
- Contraindications to glycopyrronium: hypersensitivity to glycopyrronium,
- COPD exacerbation within 6 weeks before inclusion,
- Chronic psychiatric disease,
- Medical condition that may affect handling of inhaler devices,
- Subject deprived of his/her liberty,
- Protected adult,
- Subject in exclusion period related to another protocol,
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
France1 site
CIC-P - Centre François Magendie - G3 - Hôpital Haut-Lévêque
Bordeaux, 33604
About this study
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:
- long-acting beta-2 agonist with corticosteroid (e.g. salmeterol/fluticasone),
- long-acting beta-2 agonist with anticholinergic (e.g. indacatetrol/glycopyrronium).
These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®, Handihaler® and Diskus®.
Read the detailed description
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:
- Video recording #1: inhalation (one puff) without any instruction of use,
- Video recording #2: inhalation (one puff) after reading the patient information leaflet.
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.
- Being tested
- Seretide® Diskus® 500/550 μg, Ultibro® Breezhaler® 110/50 μg, Spiriva® Respimat® 2,5 μg
- Keywords
- COPD, inhaler device, handling
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seretide® Diskus® 500/550 μgDrug
Every day during 7 days
Ultibro® Breezhaler® 110/50 μgDrug
Every day during 7 days
Spiriva® Respimat® 2,5 μgDrug
Every day during 7 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: Seretide® Diskus® 500/550 μg; Drug: Ultibro® Breezhaler® 110/50 μg; Drug: Spiriva® Respimat® 2,5 μg |
| Group 2 | Experimental | Not described Receives: Drug: Seretide® Diskus® 500/550 μg; Drug: Ultibro® Breezhaler® 110/50 μg; Drug: Spiriva® Respimat® 2,5 μg |
| Group 3 | Experimental | Not described Receives: Drug: Seretide® Diskus® 500/550 μg; Drug: Ultibro® Breezhaler® 110/50 μg; Drug: Spiriva® Respimat® 2,5 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the presence of at least a major error in the use of the inhalation system, from standardized checklist
Measured: Day 7 of each treatment
Secondary outcomes (5)
Number of non critical errors from standardized checklist
Measured: Day 7 of each treatment
Number of non device-dependant errors from standardized checklist
Measured: Day 7 of each treatment
Measure of the time necessary for drug administration
Time in second
Measured: Up to day 7 of each treatment
Measure of Forced Expiratory Volume in 1 second (FEV1)
Measured: At baseline and at day 7
Collection of adverse events
Measured: Up to day 66
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study start10 Jan 2017
- Primary completionFeb 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène PEYROUZET, Dr, Study chair, Service Hospitalo-Universitaire de Pharmacologie Médicale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813200
- Sponsor's protocol ID
- CHUBX 2014/22
- Other IDs
- 2016-001435-13, 2016
- Acronym
- INTUITIVE
- Status last verified
- Feb 2022
- First submitted
- 22 Jun 2016
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30446655
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Ability to Learn How to Handle Inhaler Devices in COPD
- ClinicalTrials.gov ID
- NCT02813200
- Acronym / sponsor ID
- INTUITIVE / CHUBX 2014/22
- Keywords
- COPD, inhaler device, handling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- long-acting beta-2 agonist with corticosteroid (e.g. salmeterol/fluticasone),
- long-acting beta-2 agonist with anticholinergic (e.g. indacatetrol/glycopyrronium).
These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®, Handihaler® and Diskus®.
Detailed description
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:
- Video recording #1: inhalation (one puff) without any instruction of use,
- Video recording #2: inhalation (one puff) after reading the patient information leaflet.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Seretide® Diskus® 500/550 μg, Drug: Ultibro® Breezhaler® 110/50 μg, Drug: Spiriva® Respimat® 2,5 μg |
| Group 2 | Experimental | Drug: Seretide® Diskus® 500/550 μg, Drug: Ultibro® Breezhaler® 110/50 μg, Drug: Spiriva® Respimat® 2,5 μg |
| Group 3 | Experimental | Drug: Seretide® Diskus® 500/550 μg, Drug: Ultibro® Breezhaler® 110/50 μg, Drug: Spiriva® Respimat® 2,5 μg |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged more than 40 years,
- Written informed consent,
- Diagnosis of COPD according to international guidelines (GOLD 2012),
- Social security or health insurance,
- Women of childbearing potential with a very effective contraception according to the Haute Autorité de Santé (HAS) recommendations.
Key exclusion criteria (14 listed)
- Previous treatment with Breezhaler®, Diskus® or Respimat® or similar device,
- QT ≥ 450 ms,
- Contraindications to tiotropium: hypersensitivity to tiotropium,
- Contraindications to indacatérol: hypersensitivity to indacatérol,
- Contraindications to salmeterol: hypersensitivity to salmeterol,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seretide® Diskus® 500/550 μgEvery day during 7 days | Drug | Group 1, Group 2, Group 3 |
| Ultibro® Breezhaler® 110/50 μgEvery day during 7 days | Drug | Group 1, Group 2, Group 3 |
| Spiriva® Respimat® 2,5 μgEvery day during 7 days | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Assessment of the presence of at least a major error in the use of the inhalation system, from standardized checklist
Time frame: Day 7 of each treatment
5 secondary outcomes
Number of non critical errors from standardized checklist
Time frame: Day 7 of each treatment
Number of non device-dependant errors from standardized checklist
Time frame: Day 7 of each treatment
Measure of the time necessary for drug administration
Time frame: Up to day 7 of each treatment
Measure of Forced Expiratory Volume in 1 second (FEV1)
Time frame: At baseline and at day 7
Collection of adverse events
Time frame: Up to day 66
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 30446655Kocks 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène PEYROUZET, Dr study chair
Service Hospitalo-Universitaire de Pharmacologie Médicale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Seretide® Diskus® 500/550 μg, Ultibro® Breezhaler® 110/50 μg and Spiriva® Respimat® 2,5 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the presence of at least a major error in the use of the inhalation system, from standardized checklist (time frame: Day 7 of each treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.