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NCT02586506 · ClinicalTrials.gov registry record · Phase 4
Study of the Ease of Use and Correct Use of Placebo ELLIPTA® Inhaler in Subjects With Asthma
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 259
- Enrollment target
NCT02586506 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 259 participants.
The verdict
NCT02586506, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 259 participants
- Enrollment target
Study Summary
Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the delivery of medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study is designed to assess the correct use of the ELLIPTA inhaler in subjects with asthma and also to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of asthma and receiving asthma therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2. ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.
Interventions
- OTHER Questionnaire
- DRUG Placebo ELLIPTA inhaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2015-10-01 |
| Est. Completion | 2016-02-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02586506
The ClinicalTrials.gov registry entry for NCT02586506 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Questionnaire is the first listed.
NCT02586506 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02586506 about?
NCT02586506 is a clinical study titled "Study of the Ease of Use and Correct Use of Placebo ELLIPTA® Inhaler in Subjects With Asthma". Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a mainstay of treatment for treatmen...
What is the current status of trial NCT02586506?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 259 participants. The study started on 2015-10-01. Estimated completion is 2016-02-04.
What interventions are being tested in trial NCT02586506?
The interventions under investigation include: Questionnaire (OTHER), Placebo ELLIPTA inhaler (DRUG).
Who is sponsoring clinical trial NCT02586506?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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