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

NCT02794480 | Completed Phase 4 Results

• 1 other identifier: 204980
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 20

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.

Conditions

Asthma

Keywords

ELLIPTA; metered dose inhaler; Dry powder inhaler

Outcome Measures

Primary Outcomes (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.

  Up to Day 56

Secondary Outcomes (4)

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

  Up to Day 56

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

  Up to Day 56

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

  Up to Day 56

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

  Up to Day 56

Study Arms (4)

Placebo ELLIPTA DPI (QD) in P1 and Placebo AZ MDI (BD) in P2

EXPERIMENTAL

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

Device: ELLIPTA DPI; Device: AZ MDI

Placebo AZ MDI (BD) in P1 and Placebo ELLIPTA DPI (QD) in P2

EXPERIMENTAL

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

Device: ELLIPTA DPI; Device: AZ MDI

Placebo ELLIPTA DPI (QD) in P1 and Placebo GSK MDI (BD) in P2

EXPERIMENTAL

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.

Device: ELLIPTA DPI; Device: GSK MDI

Placebo GSK MDI (BD) in P1 and Placebo ELLIPTA DPI (QD) in P2

EXPERIMENTAL

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

Device: ELLIPTA DPI; Device: GSK MDI

Interventions

ELLIPTA DPI DEVICE

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)

Placebo AZ MDI (BD) in P1 and Placebo ELLIPTA DPI (QD) in P2; Placebo ELLIPTA DPI (QD) in P1 and Placebo AZ MDI (BD) in P2; Placebo ELLIPTA DPI (QD) in P1 and Placebo GSK MDI (BD) in P2; Placebo GSK MDI (BD) in P1 and Placebo ELLIPTA DPI (QD) in P2

GSK MDI DEVICE

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

Placebo ELLIPTA DPI (QD) in P1 and Placebo GSK MDI (BD) in P2; Placebo GSK MDI (BD) in P1 and Placebo ELLIPTA DPI (QD) in P2

AZ MDI DEVICE

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; Placebo ELLIPTA DPI (QD) in P1 and Placebo AZ MDI (BD) in P2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (20)

GSK Investigational Site

Huntington Beach, California, 92648, United States

Location

GSK Investigational Site

Aventura, Florida, 33180, United States

Location

GSK Investigational Site

Clearwater, Florida, 33756, United States

Location

GSK Investigational Site

Miami, Florida, 33173, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21236, United States

Location

GSK Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

GSK Investigational Site

Plymouth, Minnesota, 55441, United States

Location

GSK Investigational Site

Columbia, Missouri, 65203, United States

Location

GSK Investigational Site

Rolla, Missouri, 65401, United States

Location

GSK Investigational Site

Warrensburg, Missouri, 64093, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28277, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27607, United States

Location

GSK Investigational Site

Canton, Ohio, 44718, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45231, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73120, United States

Location

GSK Investigational Site

Medford, Oregon, 97504, United States

Location

GSK Investigational Site

Orangeburg, South Carolina, 29118-2040, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Waco, Texas, 76712, United States

Location

Related Publications (1)

• 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.

  PMID: 30836228 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 9, 2016
• Study Start: August 22, 2016
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: July 2, 2019
• Results First Posted: March 16, 2018

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (20)