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AsthmaPhase 4NCT02794480

Phase IV Study in Asthma Subjects for Dry Powder Inhaler (DPI) Versus (vs) Metered Dose Inhaler (MDI) Correct Use

A Phase 4 study testing ELLIPTA DPI, GSK MDI and AZ MDI in people with Asthma, run by GlaxoSmithKline at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
ELLIPTA DPI, GSK MDI and AZ MDI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
20 sitesUnited States
Study dates
22 Aug 2016to 15 Dec 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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 locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Baltimore, Maryland, 21236

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Charlotte, North Carolina, 28277

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • GSK Investigational Site

    Columbia, Missouri, 65203

  • GSK Investigational Site

    Huntington Beach, California, 92648

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Miami, Florida, 33173

  • GSK Investigational Site

    North Dartmouth, Massachusetts, 02747

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73120

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118-2040

  • GSK Investigational Site

    Plymouth, Minnesota, 55441

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Rolla, Missouri, 65401

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Warrensburg, Missouri, 64093

Other trials in United States

About this study

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

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.

Conditions
Asthma
Being tested
ELLIPTA DPI, GSK MDI, AZ MDI
Keywords
ELLIPTA, metered dose inhaler, Dry powder inhaler
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELLIPTA DPIDevice

    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 MDIDevice

    It is the placebo inhaler with clear liquid containing propellant (1,1,1, 2- Tetrafluoroethane). It is given as oral inhalation (Inhalation Aerosol).

  • AZ MDIDevice

    It is the placebo inhaler with clear liquid. It is given as oral inhalation (Inhalation Aerosol).

Study groups in NCT02794480
Study groupRoleWhat they receive
Placebo ELLIPTA DPI (QD) in P1 and Placebo AZ MDI (BD) in P2ExperimentalEligible 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
Receives: Device: ELLIPTA DPI; Device: AZ MDI
Placebo AZ MDI (BD) in P1 and Placebo ELLIPTA DPI (QD) in P2ExperimentalEligible 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
Receives: Device: ELLIPTA DPI; Device: AZ MDI
Placebo ELLIPTA DPI (QD) in P1 and Placebo GSK MDI (BD) in P2ExperimentalEligible 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.
Receives: Device: ELLIPTA DPI; Device: GSK MDI
Placebo GSK MDI (BD) in P1 and Placebo ELLIPTA DPI (QD) in P2ExperimentalEligible 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
Receives: Device: ELLIPTA DPI; Device: GSK MDI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase

    A checklist for correct use of each inhaler was developed based on the steps identified in the package insert. Baseline assessment was conducted when the par were dispensed the inhaler and were guided by a trained healthcare provider (HCP) to demonstrate correct use of the assigned inhaler. A second assessment was conducted after each 28 day dosing period without instruction by HCP. The Correct Use Check list was completed by HCP at each visit. Percentage of par with zero errors in inhaler use at Day 28, was analyzed using a Mainland-Gart test for each ELLIPTA versus MDI comparison separately (Sub-study 1: ELLIPTA vs GSK MDI and Sub-study 2: ELLIPTA vs AZ MDI). For each ELLIPTA vs MDI analyses, only par who made no error in any of the inhalers and at least one error on the other inhaler (discordant cases) were included in the analysis. NA indicates that par did not receive the inhaler in that particular sub-study.

    Measured: Up to Day 56

Secondary outcomes (4)

  1. Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase

    The occurrence of each type of error while using ELLIPTA inhaler was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. Only par who made at least one error was included in the summary (represented by the number of Participants).

    Measured: Up to Day 56

  2. Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase

    The occurrence of each type of error while using GSK MDI in Sub-Study 1 and AZ MDI in Sub-Study 2 was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. The number of errors is reported as NA for the type of error which was not applicable to the particular inhaler type. Only par who made at least one error are included in the summary (represented by the number of Participants).

    Measured: Up to Day 56

  3. Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par)

    The number of errors per par for each inhaler (ELLIPTA and GSK MDI or AZ MDI) was evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par did not receive the inhaler in that particular sub-study.

    Measured: Up to Day 56

  4. Number of Errors Per Participant for Each After 28 Days of Use (Par With at Least One Error)

    The number of errors for each inhaler (ELLIPTA and GSK MDI or AZ MDI) in par with one or more errors were evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par. did not receive the inhaler in that particular sub-study. Only those par who made at least one error were included in the summary (represented by n=X, X in the category titles).

    Measured: Up to Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2016 (estimated)
  2. Study start22 Aug 2016
  3. Primary completion15 Dec 2016
  4. Study completion15 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02794480
Sponsor's protocol ID
204980
Status last verified
Jun 2019
First submitted
6 Jun 2016
Last updated
2 Jul 2019
Data monitoring committee
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • 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.

    PubMed 30836228

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ELLIPTA DPI, GSK MDI and AZ MDI in people with Asthma, run by GlaxoSmithKline at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to Day 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02794480, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.

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