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Completed

NCT Number: NCT01385696

Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients

Preference study: Genuair vs HandiHaler inhalers in COPD patients.

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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 3, Bonn, 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 with stable COPD
  • Naïve patients to the use of study inhalers
  • Patients agreeing on participating and signing the Informed Consent Form

Exclusion criteria

  • Patients with other clinically significant disease, particularly body malformations or diseases affecting coordination and/or motor system
  • Patients unable to read product package instructions and answer patient reported questionnaires

Treatment and study plan

Genuair® (Almirall S.A.)

Device

Inhaler with only placebo, once daily, 14 days

HandiHaler® (Boehringer Ingelheim's)

Device

Inhaler with only placebo, once daily, 14 days

Primary outcomes

  1. Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2

    Time frame: 14 days

    Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)

Secondary outcomes

  1. Mean Overall Satisfaction With Genuair and Handihaler at Visit 2

    Time frame: 14 days

    The patient will be asked to rate the overall satisfaction with each device using a Likert-type scale (from 1 [very dissatisfied] to 5 [very satisfied]) after 2 weeks of daily practice (visit 2)

  2. Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2

    Time frame: 14 days

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

    Critical error is defined as the one that compromise the potential benefit of the treatment such as those that impede drug deposition in the lungs or delivery of sufficient dose.

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study title

Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in COPD Diagnosed Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2011
Registry last updated
Jun 24, 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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