Phase IV Study in Asthma Subjects for Dry Powder Inhaler (DPI) Versus (vs) Metered Dose Inhaler (MDI) Correct Use
NCT ID: NCT02794480
Last Updated: 2019-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
324 participants
INTERVENTIONAL
2016-08-22
2016-12-15
Brief Summary
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ELLIPTA is a registered trademark of the GSK group of companies.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Placebo ELLIPTA DPI (QD) in P1 and Placebo AZ MDI (BD) in P2
Eligible subject will receive ELLIPTA DPI taken as one inhalation once daily (QD) for 28 days and Placebo AZ MDI taken as two inhalations twice daily (BD) for next 28 days. Subject will continue to take asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period
ELLIPTA DPI
It is the inhaler with two blister strips containing white coloured powder, one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. It is given as oral inhalation (Inhalation powder)
AZ MDI
It is the placebo inhaler with clear liquid. It is given as oral inhalation (Inhalation Aerosol).
Placebo AZ MDI (BD) in P1 and Placebo ELLIPTA DPI (QD) in P2
Eligible subject will receive AZ MDI taken as two inhalations twice daily for 28 days and Placebo ELLIPTA DPI taken as one inhalation once daily for next 28 days. Subject will continue to take asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period
ELLIPTA DPI
It is the inhaler with two blister strips containing white coloured powder, one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. It is given as oral inhalation (Inhalation powder)
AZ MDI
It is the placebo inhaler with clear liquid. It is given as oral inhalation (Inhalation Aerosol).
Placebo ELLIPTA DPI (QD) in P1 and Placebo GSK MDI (BD) in P2
Eligible subject will receive ELLIPTA DPI taken as one inhalation once daily for 28 days and Placebo GSK MDI taken as two inhalations twice daily for next 28 days. Subject will continue to take asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
ELLIPTA DPI
It is the inhaler with two blister strips containing white coloured powder, one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. It is given as oral inhalation (Inhalation powder)
GSK MDI
It is the placebo inhaler with clear liquid containing propellant (1,1,1, 2- Tetrafluoroethane). It is given as oral inhalation (Inhalation Aerosol).
Placebo GSK MDI (BD) in P1 and Placebo ELLIPTA DPI (QD) in P2
Eligible subject will receive GSK MDI taken as two inhalations twice daily for 28 days and Placebo ELLIPTA DPI taken as one inhalation once daily for next 28 days. Subject will continue to take asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period
ELLIPTA DPI
It is the inhaler with two blister strips containing white coloured powder, one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. It is given as oral inhalation (Inhalation powder)
GSK MDI
It is the placebo inhaler with clear liquid containing propellant (1,1,1, 2- Tetrafluoroethane). It is given as oral inhalation (Inhalation Aerosol).
Interventions
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ELLIPTA DPI
It is the inhaler with two blister strips containing white coloured powder, one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. It is given as oral inhalation (Inhalation powder)
GSK MDI
It is the placebo inhaler with clear liquid containing propellant (1,1,1, 2- Tetrafluoroethane). It is given as oral inhalation (Inhalation Aerosol).
AZ MDI
It is the placebo inhaler with clear liquid. It is given as oral inhalation (Inhalation Aerosol).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Aventura, Florida, United States
GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
North Dartmouth, Massachusetts, United States
GSK Investigational Site
Plymouth, Minnesota, United States
GSK Investigational Site
Columbia, Missouri, United States
GSK Investigational Site
Rolla, Missouri, United States
GSK Investigational Site
Warrensburg, Missouri, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Raleigh, North Carolina, United States
GSK Investigational Site
Canton, Ohio, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Medford, Oregon, United States
GSK Investigational Site
Orangeburg, South Carolina, United States
GSK Investigational Site
Spartanburg, South Carolina, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Waco, Texas, United States
Countries
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References
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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.
Other Identifiers
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204980
Identifier Type: -
Identifier Source: org_study_id
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