Study of the Ease of Use and Correct Use of Placebo ELLIPTA® Inhaler in Subjects With Asthma
Study of the Ease of Use and Correct Use of Placebo ELLIPTA® Inhaler in Subjects With Asthma
Asthma is a chronic disease of the lungs characterized by airway inflammation,
 bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone
 or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a
 mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device
 is an important consideration because an inadequate technique reduces the delivery of
 medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler
 that delivers the drug to the lungs effectively, is important. This study is designed to
 assess the correct use of the ELLIPTA inhaler in subjects with asthma and also 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 asthma and receiving asthma
 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:

 A subject will be eligible for inclusion in this study only if all of the following
 criteria apply:

 -  Age: >=18 years of age at Screening at Visit 1

 -  Diagnosis: Asthma as defined by the National Institutes of Health

 -  Reversibility of Disease: Demonstrated historical reversibility of >=12% and >=200
 millilitre (mL) reversibility of Forced Expiratory Volume in One Second (FEV1) within
 10-40 minutes following 2-4 inhalations of albuterol inhalation aerosol (or equivalent
 nebulized treatment with albuterol solution) within 24 months of Visit 1

 -  Current asthma Therapy: Currently receiving maintenance (with one or more of the
 following therapies: e.g. inhaled corticosteroid alone or in combination with
 long-acting bronchodilators, such as long-acting beta 2-agonist [LABA]) inhaler
 therapy (with no prior or ongoing use of ELLIPTA inhaler) for the treatment of asthma.
 Subjects must be able to continue using their currently prescribed asthma maintenance
 inhaler therapy throughout the study and as needed short acting betaadrenergic 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.

 -  Capable of giving signed and dated written informed consent as described in protocol
 which includes compliance with the requirements and restrictions listed in the consent
 form and in this 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

 -  Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current diagnosis of
 COPD.

 -  Asthma medications:

 Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their
 daily asthma therapy (as needed [prn] or regularly scheduled).

 Has changed maintenance asthma treatment within 4 weeks prior to Screening/Visit 1 or plans
 to change asthma treatment within 4 weeks of Visit 1.

 -  Asthma/Exacerbations/Hospitalization:

 Any asthma exacerbation, defined as deterioration of asthma requiring the use of systemic
 corticosteroids (oral, parenteral or depot) within 4 weeks of Visit 1. A subject must not
 have any hospitalisation or emergency department visit due to asthma within 3 months of
 Visit 1.

 Subjects with poorly controlled or who have unstable asthma, in the investigator's judgment
 that would affect subject's ability to evaluate "ease of use and correct use".

 History of life-threatening asthma, defined an asthma episode that required intubation
 and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.

 -  Other Respiratory Disorders: Subjects with other respiratory disorders, including
 active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis,
 pulmonary hypertension, or pulmonary disease (including, but not confined to chronic
 bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis,
 bronchopulmonary dysplasia, and chronic obstructive pulmonary disease), interstitial
 lung diseases or other active pulmonary diseases.

 -  Other Disease Abnormalities:

 Historical or current evidence of clinically significant or rapidly progressing or unstable
 cardiovascular, neurological, 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 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.

 -  Oropharyngeal Examination: Subjects with clinical visual evidence of oral candidiasis
 at Visit 1 are not eligible.

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

 -  Tobacco Use: Current smokers or subjects with a smoking history of 10 pack-years or
 more (e.g., 20 cigarettes/day for 10 years) are not eligible. A subject may not have
 used tobacco products within the past year (i.e., cigarettes, cigars, or pipe
 tobacco).

 -  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/inhaler within 30 days of entry into this study (Screening/Visit 1), or
 within five drug half-lives of the investigational drug, whichever is longer