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



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:11/11/2017
Start Date:October 1, 2015
End Date:March 15, 2016

Use our guide to learn which trials are right for you!

An Open-label Study of the Correct Use and Ease of Use of Placebo ELLIPTA Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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.


Inclusion Criteria:

- Age: >=40 years of age at Visit 1

- Diagnosis of COPD with a documented history of COPD for at least one year, in
accordance with the definition by the American Thoracic Society/European Respiratory
Society.

- Severity of Disease: Post albuterol/salbutamol forced expiratory volume in one second
(FEV1)/ forced vital capacity (FVC) ratio <0.70 and FEV1 <=70% of predicted obtained
within two years of Visit 1.

- Smoking History: Current or former (defined as subjects who have quit smoking for at
least 3 months prior to Screening/Visit 1) cigarette smokers with a >10 pack-year
smoking history (Number of pack years = [number of cigarettes per day divided by 20] x
number of years smoked [e.g., 10 pack-years is equal to 20 cigarettes per day for 10
years, or 10 cigarettes per day for 20 years]).

- Current COPD Therapy: Currently receiving maintenance (with one or more long-acting
bronchodilators, such as a long-acting muscarinic antagonist (LAMA; also known as a
long-acting anti-cholinergic) or long-acting beta 2-agonist (LABA) inhaler therapy
(with no prior or ongoing use of ELLIPTA inhaler) for the treatment of COPD. Subjects
must be able to continue using their currently prescribed COPD maintenance inhaler
therapy throughout the study and as needed short acting beta-adrenergic agonist (SABA)
for rescue use.

- Ability to Use Inhalers: Subject must be able to demonstrate correct use of ELLIPTA
inhaler within three attempts at Visit 1.

- Males

- Females who are not pregnant or not planning a pregnancy during the study or not
lactating.

- Informed Consent: Capable of giving signed and dated written informed consent which
includes compliance with the requirements and restrictions listed in the consent form
and in the protocol.

- Subject understands and is willing, able, and likely to comply with study procedures
and restrictions.

- Subject must be able to read, comprehend, and record information in English.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria
apply

- Asthma: Subjects with a current primary diagnosis of asthma.

- COPD medications: Receiving only inhaled short-acting beta-adrenergic agonists, i.e.,
albuterol as their daily COPD therapy (as needed [prn] or regularly scheduled); Has
changed maintenance COPD treatment within 4 weeks prior to Screening/Visit 1 or plans
to change COPD treatment within 4 weeks of Visit 1.

- COPD/Exacerbations/Hospitalization: Subjects that have experienced a COPD exacerbation
requiring systemic corticosteroids (oral, parenteral or depot) and/or antibiotics
within four weeks of Visit 1. A subject must not have had any hospitalization for COPD
within three months prior to Visit 1; Subjects with uncontrolled COPD, in the
investigator's judgment that would affect subject's ability to evaluate "ease of use
and correct use".

- Other Respiratory Disorders: Subjects with other respiratory disorders, including
active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis,
pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.

- Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior
to Screening/Visit 1.

- Oxygen: Use of long-term oxygen therapy (LTOT; defined as oxygen therapy prescribed
for greater than 12 hours per day) or nocturnal oxygen.

- Other Disease Abnormalities: Historical or current evidence of clinically significant
or rapidly progressing or unstable cardiovascular, neurological, renal, hepatic,
immunological, endocrine (including uncontrolled diabetes or thyroid disease) or
haematological abnormalities that are uncontrolled. Significant is defined as any
disease that, in the opinion of the investigator, would put the safety of the subject
at risk through participation, or which would affect the analysis if the
disease/condition exacerbated during the study; Subjects with a history of psychiatric
disease, intellectual deficiency, poor motivation or other conditions that will limit
the validity of informed consent to participate in the study.

- Compliance: Subjects at risk of non-compliance, or unable to comply with the study
procedures, or unable to continue their current COPD medications.

- Alcohol and Drug Abuse: A known or suspected history of alcohol or drug abuse within
the last 2 years.

- A history of hypersensitivity to any components of the study inhaler (e.g., lactose,
magnesium stearate). In addition, patients with a history of severe milk protein
allergy that, in the opinion of the study physician, contraindicates participation
will also be excluded.

- Prior or Ongoing use of the ELLIPTA inhaler (including both investigational and
commercially available product).

- Investigational Product: Subjects who have received an investigational drug and/or
medical device within 30 days of entry into this study (Screening/Visit 1), or within
five drug half-lives of the investigational drug, whichever is longer.
We found this trial at
16
sites
Richmond, Virginia 23298
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33759
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Easley, South Carolina 29640
?
mi
from
Easley, SC
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Jasper, Alabama 35501
?
mi
from
Jasper, AL
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Plymouth, Minnesota 55441
?
mi
from
Plymouth, MN
Click here to add this to my saved trials
Rock Hill, South Carolina 29732
?
mi
from
Rock Hill, SC
Click here to add this to my saved trials
Seneca, South Carolina 29678
?
mi
from
Seneca, SC
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
Union, South Carolina 29379
?
mi
from
Union, SC
Click here to add this to my saved trials