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LAMA/LABA

Phase 3FDA approved 2013

COPD | Small molecule | Respiratory |GSK plc|Trials Updated: Aug 15, 2017

LAMA/LABA development status

FDA approval Dec 18, 2013 as Anoro Ellipta
Approval holderGlaxosmithkline
ApplicationNDA203975
Highest phase Phase 3
Registered trials 2 across 2 sponsors since Dec 2011

Label indication ANORO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and effectiveness of ANORO ELLIPTA in asthma have not been established. FDA label

LAMA/LABA target and mechanism

ModalitySmall molecule

Also known as Anoro ELLIPTA

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

LAMA/LABA clinical trials

LAMA/LABA · 1 trial · 1 indication

Phase 3 1
NCT01491802Effect of a New Combination Bronchodilator on Exercise in GOLD Stage II Moderate COPDCOPD
COMPLETED17 Analytics
PHASE3COMPLETED
Effect of a New Combination Bronchodilator on Exercise in GOLD Stage II Moderate COPD
COPDUnlock trial analytics

Study Endpoints

Primary Endpoints

Exertional Dyspnea Intensity at Isotime Exercise.
4 weeks

Intensity of dyspnea (defined as breathing discomfort) at a standardized time (isotime) during constant work rate exercise tests as measured by the modified 10-point Borg scale. A rating of 0 represents no dyspnea up to a maximum of 10: a smaller rating is therefore an improvement. Isotime was defined as the highest exercise time in minutes completed in both post-treatment tests.

Secondary Endpoints

Exercise Endurance Time
4 weeks
Inspiratory Capacity at Rest
4 weeks
Ventilation at Isotime Exercise
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LAMA alone, then LAMA/LABA combinationEXPERIMENTALParticipants will first receive an inhaled long-acting muscarinic antagonist (LAMA) once daily for 4 weeks. After a 2 week washout period, they will then receive the fixed-dose combination product \[LAMA plus long-acting beta2-agonist (LABA)\] once daily for 4 weeks.
LABA/LAMA combination, then LAMA aloneEXPERIMENTALParticipants will first receive a long-acting muscarinic antagonist (LAMA) plus long-acting beta2-agonist (LABA) combination product once daily for 4 weeks. After a 2 week washout period, they will then receive the LAMA single product once daily for 4 weeks.

Interventions

NameTypeDescription
LAMA/LABADRUGGSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.
LAMADRUGGSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Stable moderate COPD * Post-bronchodilator FEV1/FVC\<0.7 and 50%≤FEV1\<80% predicted * Baseline Dyspnea Index ≤ 9 and MRC dyspnea scale \>2 * Cigarette smoking history at least 20 pack-years Exclusion Criteria: * Presence of a significant disease other than COPD that could c...

Countries:Canada
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