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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Disease, Chronic Obstructive (COPD)

Intervention / Treatment
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* Other: Patient preference questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breezhaler, then Ellipta<br>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. | Other: Patient preference questionnaire<br>* 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.<br>|
| Experimental: Ellipta, then Breezhaler<br>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. | Other: Patient preference questionnaire<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD