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)

NCT02551224 | Completed Results

• 1 other identifier: CQVA149A2405
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

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.

Conditions

Pulmonary Disease, Chronic Obstructive (COPD)

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comfort of the Mouth Pieces for Performing a Tight Seal With the Lips.

  6 hours

Study Arms (2)

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.

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.

Other: Patient preference questionnaire

Interventions

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.

Breezhaler, then Ellipta; Ellipta, then Breezhaler

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

CABA, Buenos Aires, C1426ABP, Argentina

Location

Novartis Investigative Site

Florida, Buenos Aires, B1602DQD, Argentina

Location

Novartis Investigative Site

La Plata, Buenos Aires, 1900, Argentina

Location

Novartis Investigative Site

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Novartis Investigative Site

Vicente López, Buenos Aires, B1602DOH, Argentina

Location

Novartis Investigative Site

Buenos Aires, B1842DID, Argentina

Location

Novartis Investigative Site

Buenos Aires, C1120AAC, Argentina

Location

Novartis Investigative Site

Buenos Aires, C1425AUA, Argentina

Location

Novartis Investigative Site

CABA, Argentina

Location

Novartis Investigative Site

Ciudad Autonoma de Bs As, C1425FVH, Argentina

Location

Related Publications (1)

• 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.

  PMID: 29649916 DERIVED

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 16, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 18, 2017
• Results First Posted: October 9, 2017

Record last verified: 2017-11

Locations

AR (10)