Advantage: 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)

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02551224
• Collaborator: (none)
• Enrollment: 100
• Locations: 10
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 10
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive (COPD)	Other: Patient preference questionnaire	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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® deviceopen-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)
• Primary Purpose: Other
• 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
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breezhaler, then Ellipta 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; 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.
Experimental: Ellipta, then Breezhaler 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; 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.

Outcome Measures

Primary Outcome Measures

1. Patient's Preference on the Feedback Mechanisms of Dose Delivery Confirmation Using the Breezhaler® and Ellipta® Devices [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

Secondary Outcome Measures

1. Comfort of the Mouth Pieces for Performing a Tight Seal With the Lips. [6 hours]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Caba	Buenos Aires	Argentina	C1426ABP
2	Novartis Investigative Site	Florida	Buenos Aires	Argentina	B1602DQD
3	Novartis Investigative Site	La Plata	Buenos Aires	Argentina	1900
4	Novartis Investigative Site	Mar del Plata	Buenos Aires	Argentina	7600
5	Novartis Investigative Site	Vicente Lopez	Buenos Aires	Argentina	B1602DOH
6	Novartis Investigative Site	Buenos Aires		Argentina	B1842DID
7	Novartis Investigative Site	Buenos Aires		Argentina	C1120AAC
8	Novartis Investigative Site	Buenos Aires		Argentina	C1425AUA
9	Novartis Investigative Site	Caba		Argentina
10	Novartis Investigative Site	Ciudad Autonoma de Bs As		Argentina	C1425FVH

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02551224
• Other Study ID Numbers: CQVA149A2405
• First Posted: Sep 16, 2015
• Last Update Posted: Dec 18, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Novartis Pharmaceuticals: COPD
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

Participant Flow

Arm/Group Title	Breezhaler, Then Ellipta group1	Ellipta Then, Breezhaler Group 2
Arm/Group Description	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.	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.
Period Title: First Intervention
STARTED	50	50
COMPLETED	50	50
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	50	50
COMPLETED	50	50
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	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.
Overall Participants	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.2 (9.07)
Sex: Female, Male (Count of Participants)
Female	36 36%
Male	64 64%

Outcome Measures

1. Primary Outcome

Title	Patient's Preference on the Feedback Mechanisms of Dose Delivery Confirmation Using the Breezhaler® and Ellipta® Devices
Description	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
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Breezhaler	Ellipta
Arm/Group Description	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.	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.
Measure Participants	100	100
Mean (Standard Deviation) [units on a scale]	4.3 (0.82)	3.6 (1.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Breezhaler, Ellipta
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.51 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Comfort of the Mouth Pieces for Performing a Tight Seal With the Lips.
Description	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)
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

full analysis set

Arm/Group Title	Breezhaler	Ellipta
Arm/Group Description	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.	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.
Measure Participants	100	100
Mean (Standard Deviation) [units on a scale]	4.3 (0.70)	3.9 (0.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Breezhaler, Ellipta
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 95%; 0.21 to 0.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Breezhaler		Ellipta
Arm/Group Description	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.		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.
All Cause Mortality
	Breezhaler		Ellipta
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Breezhaler		Ellipta
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	Breezhaler		Ellipta
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/100 (1%)		0/100 (0%)
Infections and infestations
rhinitis	1/100 (1%)	1	0/100 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.