Ease of Use and Correct Use Study of Placebo ELLIPTA® Inhaler in COPD Subjects

2015-10-27 14:08:23 | BioPortfolio


Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The mainstay for treatment involves the use of inhaled medications, including short and/or long-acting bronchodilators along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study will assess the correct use of the ELLIPTA inhaler by subjects with COPD and to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of COPD and receiving COPD therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2.

ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


Pulmonary Disease, Chronic Obstructive


Placebo, Questionnaire


Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2015-10-27T14:08:23-0400

Clinical Trials [3869 Associated Clinical Trials listed on BioPortfolio]

Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of the study is to validate the questionnaire in patients who have sudden, sustained worsening of their baseline condition commonly known as chronic obstructive pulmo...

Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate a new questionnaire to capture the patient experience of COPD. The information collected will be used to validate the Shortness of Breath with Dail...

Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients

Chronic obstructive pulmonary disease (COPD) is a chronic condition involving an impairment in functionality and in the execution of activities of daily life. The hypothesis of this study ...

Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)

It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 ...

Exercise Study in Patient With Chronic Obstructive Pulmonary Disease

To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).

PubMed Articles [22850 Associated PubMed Articles listed on BioPortfolio]

Exploring the Views of Individuals With Chronic Obstructive Pulmonary Disease on the Use of Rollators: A QUALITATIVE STUDY.

Although it has been well documented that the progressive exercise limitation associated with chronic obstructive pulmonary disease can be helped with an assistive device, such as a rollator, many ind...

The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in Individuals With COPD.

This randomized controlled experimental study was conducted to investigate the effect of progressive muscle relaxation exercises on dyspnea, fatigue, and sleep quality in individuals with chronic obst...

Impaired Mitochondrial Microbicidal Responses in Chronic Obstructive Pulmonary Disease Macrophages.

Chronic obstructive pulmonary disease (COPD) is characterized by impaired clearance of pulmonary bacteria.

Comorbidities in Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation Outcomes.

The objective of this study was to evaluate the impact of comorbidities as potential predictors of the response to pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD...

Outcome Measures Used in Pulmonary Rehabilitation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Systematic Review.

Conflicting results about the effects of community-based pulmonary rehabilitation in acute exacerbations of chronic obstructive pulmonary disease (AECOPD) exist, possibly because the variety of outcom...

Medical and Biotech [MESH] Definitions

A disease of chronic diffuse irreversible airflow obstruction. Subcategories of COPD include CHRONIC BRONCHITIS and PULMONARY EMPHYSEMA.

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

A subcategory of CHRONIC OBSTRUCTIVE PULMONARY DISEASE. The disease is characterized by hypersecretion of mucus accompanied by a chronic (more than 3 months in 2 consecutive years) productive cough. Infectious agents are a major cause of chronic bronchitis.

A scopolamine derivative and CHOLINERGIC ANTAGONIST that functions as a BRONCHODILATOR AGENT. It is used in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

More From BioPortfolio on "Ease of Use and Correct Use Study of Placebo ELLIPTA® Inhaler in COPD Subjects"

Quick Search

Relevant Topics

COPD (chronic obstructive pulmonary disease)
COPD (chronic obstructive pulmonary disease) is used for a number of conditions including chronic bronchitis and emphysema, which all  lead to the airways in the lungs becoming damaged and thus narrower,  making inhalation and exhalation harder...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Searches Linking to this Trial