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OpenTrials
Completed

NCT Number: NCT01915784

Preference, Satisfaction and Ease of Use of Genuair® (Pressair™) and Breezhaler® (Neohaler™) Inhalers in Patients With COPD

Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with COPD

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Almirall investigative site 2, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male or female patients aged ≥40 years with stable moderate-to-severe COPD according to the GOLD Guidelines classification (grades II and III): forced expiratory volume in 1 second (measured between 10 to 15 minutes post-inhalation of 400 μg of salbutamol) is 30%≤FEV1<80% of the predicted normal value
  • Patients naïve to both study inhaler devices, Genuair® and Breezhaler®, for at least 2 years
  • Agreement to participate and voluntarily sign the informed consent form

Exclusion criteria

  • Patients with other clinically significant uncontrolled chronic diseases, particularly body malformations or diseases affecting coordination and/or motor system
  • Patients unable to read product package instructions and answer patient reported questionnaires (PASAPQ)
  • Patients with any other serious or uncontrolled mental health problems
  • Patients currently participating in other randomised clinical studies
  • Patients with COPD exacerbation within 6 weeks before Visit 1 and patient hospitalised for COPD exacerbation within 3 months prior to Visit 1
  • Patients with any other conditions that, in the investigator's opinion, might indicate the patient to be inappropriate for the study
  • Patient likely to be uncooperative

Treatment and study plan

Genuair®

Device

Inhaler with placebo only. Once daily, for 14 days.

Other names: Pressair™

Breezhaler®

Device

Inhaler with placebo only. Once daily, for 14 days.

Other names: Neohaler®

Primary outcomes

  1. Percentage of patients who prefer Genuair® (Pressair™) versus Breezhaler® (Neohaler™) at Visit 2

    Time frame: 14 Days

    Patients will be asked to answer which device they prefer after 2 weeks of daily practice recorded via PASAPQ (Patient Satisfaction and Preference Questionnaire) a self-administered, 15-item measure of respiratory inhalation device satisfaction and preference. The PASAPQ 15-item instrument includes 13 satisfaction items [using a Likert-type scale from 1 (very dissatisfied) to 7 (very satisfied)], a preference item, and a question on willingness to continue using the device.

Secondary outcomes

  1. Mean for the overall satisfaction score with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2

    Time frame: 14 Days

    Patients will be asked to rate the overall satisfaction with each device using a Likert-type scale (from 1 [very dissatisfied] to 7 [very satisfied]) after 2 weeks of daily practice recorded via PASAPQ (Patient Satisfaction and Preference Questionnaire) a self-administered, 15-item measure of respiratory inhalation device satisfaction and preference. The PASAPQ 15-item instrument includes 13 satisfaction items [using a Likert-type scale from 1 (very dissatisfied) to 7 (very satisfied)], a preference item, and a question on willingness to continue using the device.

  2. Percentage of patients making at least 1 critical error with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2

    Time frame: 14 Days

    The correct use of each device will be assessed measuring the errors made by patients when using each device after 2 weeks of daily practice

    Critical errors for each inhaler device are defined as those that compromise the potential benefit of the treatment such as impeding drug deposition in the lungs or the delivery of a sufficient dose

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Collaborators

  • Forest Laboratories

Registry information

Official study title

Study Evaluating Preference, Satisfaction and Ease of Use of Genuair® (Pressair™) and Breezhaler® (Neohaler™) Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 5, 2013
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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