Last updated: 07/17/2024 17:23:38
Phase IV study in asthma subjects for dry powder inhaler (DPI) versus (vs) metered dose inhaler (MDI) correct use
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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:
Frequency of errors by type for ELLIPTA after 28 days of use in each treatment phase
Timeframe: Up to Day 56
Frequency of errors by type for MDI after 28 days of use in each treatment phase
Timeframe: Up to Day 56
Number of errors per participant for each inhaler after 28 days of use (all evaluable par)
Timeframe: Up to Day 56
Number of errors per participant for each after 28 days of use (par with at least one error)
Timeframe: Up to Day 56
Interventions:
Enrollment:
324
Primary completion date:
2016-15-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Edward M. Kerwin, Andrew Preece, Dimitra Brintziki, Kathryn A. Collison, Raj Sharma. ELLIPTA dry powder versus metered-dose inhalers in an optimized clinical trial setting. J Allergy Clin Immunol Pract. 2019;7(6):1843-1849
DOI: 10.1016/j.jaip.2019.02.023
PMID: 30836228
Medical condition
Asthma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2016 to December 2016
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- - Subjects aged 18 years or older, at the time of signing the informed consent
- Documented history of moderate persistent asthma
- 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)
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28277
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Showing 1 - 6 of 20 Results
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2016-15-12
Actual study completion date
2016-15-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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