NCT01915784

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_3

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

August 1, 2013

Last Update Submit

May 28, 2015

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

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

    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.

    14 Days

Secondary Outcomes (2)

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

    14 Days

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

    14 Days

Study Arms (2)

Group A

EXPERIMENTAL

Genuair® (Pressair™) first; Breezhaler® (Neohaler™) second

Device: Genuair®Device: Breezhaler®

Group B

EXPERIMENTAL

Breezhaler® (Neohaler™) first; Genuair® (Pressair™) second

Device: Genuair®Device: Breezhaler®

Interventions

Genuair®DEVICE

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

Also known as: Pressair™
Group AGroup B
Breezhaler®DEVICE

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

Also known as: Neohaler®
Group AGroup B

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Almirall investigative site 2

Berlin, Germany

Location

Almirall investigative site 1

Munich, Germany

Location

Almirall investigative site 3

Barcelona, Spain

Location

Almirall investigative site 4

Palma de Mallorca, Spain

Location

Almirall investigative site 5

Glasgow, United Kingdom

Location

Almirall investigative site 6

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jordi Estruch, MD

    Almirall, S.A.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2013

First Posted

August 5, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

DE(2)GB(2)ES(2)