Clinical trial NCT02551224: 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)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive (COPD)
Keywords: COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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® device
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient's Preference on the Feedback Mechanisms of Dose Delivery Confirmation Using the Breezhaler® and Ellipta® Devices
timeFrame: 6 hours
Secondary outcomes:
measure: Comfort of the Mouth Pieces for Performing a Tight Seal With the Lips.
timeFrame: 6 hours
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Florida
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Vicente Lopez
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Caba
country: Argentina
facility: Novartis Investigative Site
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
Study officials:
References:
citation: 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.