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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient preference questionnaire | Other | 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. |
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| 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 |
| 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 |
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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.):
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | CABA | Buenos Aires | C1426ABP | Argentina | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29649916 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Breezhaler, Then Ellipta group1 | Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires are administered after using each device. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
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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
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| Florida |
| Buenos Aires |
| B1602DQD |
| Argentina |
| Novartis Investigative Site | La Plata | Buenos Aires | 1900 | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Novartis Investigative Site | Vicente López | Buenos Aires | B1602DOH | Argentina |
| Novartis Investigative Site | Buenos Aires | B1842DID | Argentina |
| Novartis Investigative Site | Buenos Aires | C1120AAC | Argentina |
| Novartis Investigative Site | Buenos Aires | C1425AUA | Argentina |
| Novartis Investigative Site | CABA | Argentina |
| Novartis Investigative Site | Ciudad Autonoma de Bs As | C1425FVH | Argentina |
| Ellipta Then, Breezhaler Group 2 |
Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires administered after using each device. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Intervention (5 Min After First ) |
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A total of 100 subjects were randomized, all of whom were included in the FAS and the safety set
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Full analysis set | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
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| Secondary | 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) | full analysis set | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breezhaler | Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device. | 0 | 100 | 1 | 100 | ||
| EG001 | Ellipta | Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires were administered after using each device. | 0 | 100 | 0 | 100 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rhinitis | Infections and infestations | meddra 18.1 | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until publication of the pooled data (i.e.,data from all sites)in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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