Clinical trial NCT02794480: Phase IV Study in Asthma Subjects for Dry Powder Inhaler (DPI) Versus (vs) Metered Dose Inhaler (MDI) Correct Use
Official title: 204980: An Open-label Study to Evaluate the Correct Use of Placebo ELLIPTA™ Dry Powder Inhaler (DPI) Compared to Placebo Metered Dose Inhalers (MDI) in Subjects With Moderate Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: ELLIPTA
metered dose inhaler
Dry powder inhaler
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-06-09
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is conducted to evaluate the potentially improved patient handling of the ELLIPTA Dry Powder Inhaler (DPI). Therefore, the study aims to evaluate errors encountered by subject with asthma during handling ELLIPTA DPI relative to two metered dose inhalers (MDI), a GSK MDI and the AstraZeneca (AZ) MDI. It is a randomised, multi-centre, open-label, cross-over study comparing placebo ELLIPTA DPI with placebo MDI (GSK and AZ) to assess correct inhaler use. No active drug will be used in this study in order to prevent any drug-related effects. Approximately, 152 subjects will be randomized to receive ELLIPTA DPI inhaler and 152 will be randomized to receive one of the MDI inhalers, for use during the first period (P) (approximately 28 days). At Visit 2 (Day 28) all subjects previous receiving the ELLIPTA DPI will be randomized to receive one of the MDI inhalers and all subjects who received a MDI in the previous period will receive the ELLIPTA DPI for use during second period (approximately 28 days). Subjects will continue taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.

ELLIPTA is a registered trademark of the GSK group of companies.


Eligibility criteria: Inclusion Criteria:

* - Subjects aged 18 years or older, at the time of signing the informed consent
* Documented history of moderate persistent asthma
* Asthma Control Test (ACT) score \>=20
* Male or Females (who are not pregnant or planning pregnancy during the study or not lactating)
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions
* 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
* Should not have received maintenance therapy via MDI or ELLIPTA in the past six months (DISKUS (trade name owned by GSK group of companies under license), TWISTHALER (trade name owned by Merck Sharp \& Dohme Corporation, a subsidiary of Merck \& Co, under license, etc are acceptable). Subject must be on maintenance therapy for 3 months, have not changed dose in the month prior to inclusion and be able to continue using their maintenance therapy throughout the study
* Requires Short-acting-beta-agonist (SABA) for symptom control =\<2 days/week. Use of SABA prior to exercise for the prevention of exercise induced bronchoconstriction is exclusionary.

Exclusion Criteria:

* Subjects with a known or suspected alcohol or drug abuse at Visit 1 which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement
* Current smokers or subjects with a smoking history of 10 pack-years or more (example, 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)
* Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
* History of life threatening asthma or has experienced more than 1 exacerbation which required oral/systemic corticosteroids in the 12 months prior to Visit 1
* History of hypersensitivity to any components of the study inhaler (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation
* 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 hematological 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 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
* A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.

Primary outcomes:
measure: Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase
timeFrame: Up to Day 56
Secondary outcomes:
measure: Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase
timeFrame: Up to Day 56
measure: Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase
timeFrame: Up to Day 56
measure: Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par)
timeFrame: Up to Day 56
measure: Number of Errors Per Participant for Each After 28 Days of Use (Par With at Least One Error)
timeFrame: Up to Day 56
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Aventura
country: United States
facility: GSK Investigational Site
state: Florida
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: North Dartmouth
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Plymouth
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Columbia
country: United States
facility: GSK Investigational Site
state: Missouri
city: Rolla
country: United States
facility: GSK Investigational Site
state: Missouri
city: Warrensburg
country: United States
facility: GSK Investigational Site
state: Missouri
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Orangeburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Waco
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Kerwin EM, Preece A, Brintziki D, Collison KA, Sharma R. ELLIPTA Dry Powder Versus Metered-Dose Inhalers in an Optimized Clinical Trial Setting. J Allergy Clin Immunol Pract. 2019 Jul-Aug;7(6):1843-1849. doi: 10.1016/j.jaip.2019.02.023. Epub 2019 Mar 2.