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ELLIPTA, DISKUS

Phase 3

Pulmonary Disease, Chronic Obstructive | Unknown | Respiratory |GSK plc|Last Updated: Mar 4, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment287

FDA Designations

No designations recorded

Clinical trial landscape

ELLIPTA, DISKUS · 1 trial · 1 indication

Phase 3 1
NCT01868009DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD)Pulmonary Disease, Chronic Obstructive
COMPLETED287 Analytics
PHASE3COMPLETED
DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter
up to Study Day 26

The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence.

Secondary Endpoints

Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication
up to Study Day 26
Number of Participants With the Indicated Device Preference Based on the Size of the Device
up to Study Day 26
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ELLIPTA Period 1 and DISKUS Period 2 ArmEXPERIMENTALSubjects will use the ELLIPTA inhaler once daily for 5 to 9 days during the first period followed by the DISKUS inhaler twice daily for 5 to 9 days during the second period.
DISKUS Period 1 and ELLIPTA Period 2 ArmEXPERIMENTALSubjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period.

Interventions

NameTypeDescription
ELLIPTADEVICENovel dry powder inhaler (placebo) with 30 doses (2 strips with 30 blisters per strip)
DISKUSDEVICEMultidose dry powder inhaler (placebo) containing a foil strip worth 60 blisters (1 strip with 60 blisters per strip)
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * 1\. Informed consent * Subject must give their signed and dated written informed consent to participate. * 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 ...

Countries:United States
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Frequently asked questions about ELLIPTA, DISKUS

What is ELLIPTA DISKUS used for in chronic obstructive pulmonary disease?

ELLIPTA DISKUS is an investigational inhaler device combination studied for use in chronic obstructive pulmonary disease (COPD). It was evaluated in a Phase 3 clinical trial to assess patient preference between the DISKUS and ELLIPTA devices. The study enrolled 287 participants aged 40 years and older in the United States.

Who makes ELLIPTA DISKUS?

ELLIPTA DISKUS is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK conducted a Phase 3 clinical trial to evaluate the device preference between DISKUS and ELLIPTA in patients with chronic obstructive pulmonary disease.

What phase is ELLIPTA DISKUS in?

ELLIPTA DISKUS is in Phase 3 clinical development. It has completed one Phase 3 trial, NCT01868009, which was a controlled, randomized study in chronic obstructive pulmonary disease. The trial is completed, and the drug remains investigational, not yet approved by regulatory authorities.

What clinical trials is ELLIPTA DISKUS in?

ELLIPTA DISKUS has one completed Phase 3 clinical trial, NCT01868009, titled 'DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD)'. This randomized, controlled study enrolled 287 participants in the United States and is now completed.

Is ELLIPTA DISKUS the same as DISKUS or ELLIPTA?

ELLIPTA DISKUS refers to a combination of two inhaler devices, DISKUS and ELLIPTA, studied together in a clinical trial. The trial compared patient preference between the two devices in chronic obstructive pulmonary disease. ELLIPTA DISKUS is not a single drug but a device combination evaluated by GSK.