Pulmonary Disease, Chronic Obstructive (COPD)AdvantageNCT02551224

Preference on the Feedback Mechanisms of Dose Delivery Confirmation With the Breezhaler® Device Compared to the Ellipta® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A study testing Patient preference questionnaire in people with Pulmonary Disease, Chronic Obstructive (COPD), run by Novartis Pharmaceuticals at 10 sites in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare in COPD patients naïve to DPIs, the perception of the Breezhaler® and Ellipta® devices' feedback mechanisms evaluated using a preference questionnaire. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive (COPD)
What is being tested?: Patient preference questionnaire
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 10 sitesArgentina
Study dates: Sep 2015to Mar 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients with diagnosis of COPD (mild to very severe disease) based on post-bronchodilator FEV1 values in patients with FEV1/FVC <0.70.
No previous use of DPI.
Over and either be current smokers or have a history of smoking >10 years. (e.g., 10 pack years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.):
Note: A pack of cigarettes is equal to 20 cigarettes. Occasional smoking of cigars is not relevant to smoking history.
An ex-smoker is defined as a patient who has not smoked for ≥6 months at screening.
Willing and able to reproducibly perform spirometry and inhalational manoeuvers as required by the protocol.
Willing and able to comprehend and follow the instructions for use of the inhalational devices to be tested in the study.
Questions or requests for clarification regarding the eligibility of a particular patient based on the above inclusion criteria should be directed to the medical monitor before the patient is enrolled.

Who cannot join

History of hypersensitivity to the components of the placebo used in the study or to compounds of similar chemical classes. This includes (but is not exhaustive) patients with known lactose allergy, allergy to magnesium stearate, and those who have suffered paradoxical bronchospasm on inhalation of placebo medications.
Patients who received treatment with systemic corticosteroids, antibiotics, or had a history suggestive of acute COPD exacerbation and/or hospitalization within 12 weeks prior to the screening or during the baseline period.
Pregnant or nursing (lactating) women, defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS:
Women with reliable contraception methods.
Post-menopausal women with no possibility of becoming pregnant.

Show all 15Show fewer

Note: Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to baseline. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
Patients with a history (at Visit 1) of asthma indicated by (but not limited to):
Onset of respiratory symptoms suggestive of asthma (such as cough, wheezing, shortness of breath) prior to age 40.
History of a diagnosis of asthma.
Patients with allergic rhinitis who use an H1 antagonist or intra-nasal corticosteroids intermittently (Treatment with a stable dose or regimen is permitted).
History of clinically significant conditions including: significant cardiovascular disease, uncontrolled diabetes, a history of non-compliance, alcohol or drug abuse, any patient with active cancer, or any condition in the opinion of the investigator that makes the patient unsuitable for participation in this study.
Use of investigational drugs (approved or unapproved) in the 3 months before screening.
Within the 7 days prior to the visits, an increase in episodic use of rescue bronchodilator more than double the average number of puffs used in the preceding week or more than 8 puffs of SABA on any 3 consecutive days or more than 12 puffs of SABA on any 2 consecutive days.
Respiratory tract infections (sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection) within the 4weeks before the visit.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Argentina10 sites

Novartis Investigative Site
Buenos Aires, B1842DID
Novartis Investigative Site
Buenos Aires, C1120AAC
Novartis Investigative Site
Buenos Aires, C1425AUA
Novartis Investigative Site
CABA, Buenos Aires, C1426ABP
Novartis Investigative Site
CABA
Novartis Investigative Site
Ciudad Autonoma de Bs As, C1425FVH
Novartis Investigative Site
Florida, Buenos Aires, B1602DQD
Novartis Investigative Site
La Plata, Buenos Aires, 1900
Novartis Investigative Site
Mar del Plata, Buenos Aires, 7600
Novartis Investigative Site
Vicente López, Buenos Aires, B1602DOH

Other trials in Argentina

About this study

Official title: A Randomized, Open-label, Cross-over Study Comparing the Preference on the Feedback Mechanisms of Dose Delivery Confirmation With the Breezhaler® Device Compared to the Ellipta® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD): The Advantage Study

The purpose of this study is to compare in COPD patients naïve to DPIs, the perception of the Breezhaler® and Ellipta® devices' feedback mechanisms evaluated using a preference questionnaire.

Conditions: Pulmonary Disease, Chronic Obstructive (COPD)
Being tested: Patient preference questionnaire
Keywords: COPD
Medical subject headings: Lung Diseases, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient preference questionnaireOther
The primary variable will be the mean score of questions 1(a) to 1(c) from the preference questionnaire completed at the end of study.

Study groups in NCT02551224
Study group	Role	What they receive
Breezhaler, then Ellipta	Experimental	Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires after using each device. Receives: Other: Patient preference questionnaire
Ellipta, then Breezhaler	Experimental	Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires after using each device. Receives: Other: Patient preference questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient's Preference on the Feedback Mechanisms of Dose Delivery Confirmation Using the Breezhaler® and Ellipta® Devices
This study will measure patient's perceptions of dose delivery, using a preference questionnaire on use of the Breezhaler® \& Ellipta® devices, in COPD patients naïve to DPI devices.The mean (SD) score on a scale of 1- 5 (1 = not at all confident/not at all; 5 = extremely confident/a very great deal) 1a. How confident were you that you received the full dose of medication from your inhaler?
1=Not At All Confident, 2=Not Very Confident, 3=Somewhat Confident, 4=Confident, 5=Extremely Confident
1b. How certain were you that there was no drug remaining in the device?
1=Not At All Certain,2=Not Very Certain, 3=Somewhat Certain,4=Certain, 5=Extremely Certain
1c. To what extent did the device help you to know that you have received all the medication?
1=Not At All, 2=A Little, 3=Somewhat, 4=Very Much, 5=A Very Great Deal
Measured: 6 hours

Secondary outcomes (1)

Comfort of the Mouth Pieces for Performing a Tight Seal With the Lips.
To measure in COPD patients naïve to DPIs, the comfort of the mouth pieces when performing a tight seal with the lips using the Breezhaler® and Ellipta® devices.The mean (SD) score on a scale of 1 - 5 (1 = not at all easy, 2= not very easy, 3=somewhat easy, 4=very easy, 5 = extremely easy)
Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Mar 2016

First posted16 Sep 2015 (estimated)
Study startSep 2015
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic Obstructive (COPD)Studies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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 N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: open-label, cross-over study comparing the preference on the feedback mechanisms of dose delivery confirmation with the Breezhaler® device compared to the Ellipta® device
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02551224
Sponsor's protocol ID: CQVA149A2405
Acronym: Advantage
Status last verified: Nov 2017
First submitted: 31 Aug 2015
Last updated: 18 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Altman P, Bergna MA, Garcia GR, Guerin T, Pino AV, Whiteford JL. Patient perception of Breezhaler(R) and Ellipta(R) device feedback mechanisms in COPD: The ADVANTAGE Study. Curr Med Res Opin. 2019 Feb;35(2):221-227. doi: 10.1080/03007995.2018.1464437. Epub 2018 May 15.
PubMed 29649916

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Cross-over Study Comparing the Preference on the Feedback Mechanisms of Dose Delivery Confirmation With the Breezhaler® Device Compared to the Ellipta® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD): The Advantage Study
ClinicalTrials.gov ID: NCT02551224
Acronym / sponsor ID: Advantage / CQVA149A2405
Conditions: Pulmonary Disease, Chronic Obstructive (COPD)
Keywords: COPD
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 16 Sep 2015 (estimated)
Results: Posted 9 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare in COPD patients naïve to DPIs, the perception of the Breezhaler® and Ellipta® devices' feedback mechanisms evaluated using a preference questionnaire.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: open-label, cross-over study comparing the preference on the feedback mechanisms of dose delivery confirmation with the Breezhaler® device compared to the Ellipta® device

Arm	Type	Receives
Breezhaler, then Ellipta	Experimental	Other: Patient preference questionnaireHalf of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires after using each device.
Ellipta, then Breezhaler	Experimental	Other: Patient preference questionnaireHalf of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires after using each device.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients with diagnosis of COPD (mild to very severe disease) based on post-bronchodilator FEV1 values in patients with FEV1/FVC <0.70.
No previous use of DPI.
Over and either be current smokers or have a history of smoking >10 years. (e.g., 10 pack years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.):
Willing and able to reproducibly perform spirometry and inhalational manoeuvers as required by the protocol.
Willing and able to comprehend and follow the instructions for use of the inhalational devices to be tested in the study.

Key exclusion criteria (15 listed)

History of hypersensitivity to the components of the placebo used in the study or to compounds of similar chemical classes. This includes (but is not exhaustive) patients with known lactose allergy, allergy to magnesium stearate, and those who have suffered paradoxical bronchospasm on inhalation of placebo medications.
Patients who received treatment with systemic corticosteroids, antibiotics, or had a history suggestive of acute COPD exacerbation and/or hospitalization within 12 weeks prior to the screening or during the baseline period.
Pregnant or nursing (lactating) women, defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS:
Patients with a history (at Visit 1) of asthma indicated by (but not limited to):

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
Patient preference questionnaireThe primary variable will be the mean score of questions 1(a) to 1(c) from the preference questionnaire completed at the end of study.	Other	Breezhaler, then Ellipta, Ellipta, then Breezhaler

Primary outcome

Patient's Preference on the Feedback Mechanisms of Dose Delivery Confirmation Using the Breezhaler® and Ellipta® Devices
Time frame: 6 hours
This study will measure patient's perceptions of dose delivery, using a preference questionnaire on use of the Breezhaler® \& Ellipta® devices, in COPD patients naïve to DPI devices.The mean (SD) score on a scale of 1- 5 (1 = not at all confident/not at all; 5 = extremely confident/a very great deal) 1a. How confident were you that you received the full dose of medication from your inhaler? 1=Not At All Confident, 2=Not Very Confident, 3=Somewhat Confident, 4=Confident, 5=Extremely Confident 1b. How certain were you that there was no drug remaining in the device? 1=Not At All Certain,2=Not Very Certain, 3=Somewhat Certain,4=Certain, 5=Extremely Certain 1c. To what extent did the device help you to know that you have received all the medication? 1=Not At All, 2=A Little, 3=Somewhat, 4=Very Much, 5=A Very Great Deal

1 secondary outcome

Comfort of the Mouth Pieces for Performing a Tight Seal With the Lips.
Time frame: 6 hours

Results and safety

Results posted to the registry on 9 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Breezhaler, Then Ellipta group1	50	50
Ellipta Then, Breezhaler Group 2	50	50

Primary outcome: Patient's Preference on the Feedback Mechanisms of Dose Delivery Confirmation Using the Breezhaler® and Ellipta® Devices

Time frame: 6 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Breezhaler n = 100	Ellipta n = 100
Value	4.3 (0.82)	3.6 (1.05)

Breezhaler vs Ellipta: Mean Difference (Net): 0.75 (95% CI 0.51 to 0.99), p <0.0001, Wilcoxon (Mann-Whitney)

Population analysed: Full analysis set

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Breezhaler	0 of 100 (0%)	1 of 100 (1%)	Not reported
Ellipta	0 of 100 (0%)	0 of 100 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29649916Altman P, Bergna MA, Garcia GR, Guerin T, Pino AV, Whiteford JL. Patient perception of Breezhaler(R) and Ellipta(R) device feedback mechanisms in COPD: The ADVANTAGE Study. Curr Med Res Opin. 2019 Feb;35(2):221-227. doi: 10.1080/03007995.2018.1464437. Epub 2018 May 15.

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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.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Patient preference questionnaire in people with Pulmonary Disease, Chronic Obstructive (COPD), run by Novartis Pharmaceuticals at 10 sites in Argentina.

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 8 inclusion and 15 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 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Argentina. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient's Preference on the Feedback Mechanisms of Dose Delivery Confirmation Using the Breezhaler® and Ellipta® Devices (time frame: 6 hours). 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 NCT02551224, 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 18 Dec 2017.