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)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02551224
• Date of registration: 31/08/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: 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) Advantage
• Scientific 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
• Date of first enrolment: September 2015
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02551224
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Argentina

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Disease, Chronic Obstructive (COPD)

Intervention(s)

Other: Patient preference questionnaire

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

CQVA149A2405

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/10/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02551224