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A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma

Study category: Respiratory

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Description

GSK is currently developing a once-daily ?closed? triple therapy of an ICS/LAMA/LABA combination [FF/UMEC/Vilanterol (VI)] in a single device, with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over established combination therapies. Through the comparison of a closed triple therapy to a standard of care ICS/LABA combination therapy this study will provide important information to prescribers regarding the benefit of step-up to closed triple therapy to patients uncontrolled on ICS/LABA.

Details
Age

Adult

Eligibility

AGE 1. 18 years of age or older at the time of signing the informed consent. TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY 2. Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes of Health [NIH 2007] at least one year prior to Visit 0. 3. Symptomatic: Subjects with inadequately controlled asthma (ACQ-6 score ≥1.5) despite ICS/LABA maintenance therapy at Visit 1.

Detailed Eligibility: 18 years of age or older at the time of signing the informed consent. 2. Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes of Health [NIH 2007] at least one year prior to Visit 0. 3. Symptomatic: Subjects with inadequately controlled asthma (ACQ-6 score ≥1.5) despite ICS/LABA maintenance therapy at Visit 1. 4. Asthma Control: Note: please refer to the SRM for guidance on the following: In the 1 year prior to Visit 1:  A documented healthcare contact for acute asthma symptoms OR  A documented temporary change in asthma therapy for acute asthma symptoms, according to a pre-specified asthma action plan (or equivalent) 5. Current Asthma Maintenance Therapy: Subjects are eligible if they have required daily ICS/LABA for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total dose of ICS of >250 mcg/day fluticasone proprionate [FP, or equivalent]). Examples of acceptable doses of commonly prescribed ICS medication are provided in the GINA guidelines [GINA 2016], [BTS/SIGN 2016], [Japanese guidelines for adult asthma 2017]. Dosing regimen (once or twice daily to equal the total daily dose) should be restricted to the current local product labels/treatment guidelines. 6. Spirometry: A best pre-bronchodilator morning (AM) FEV1 ≥30% and <85% of the predicted normal value at Visit 1. Predicted values will be based upon the European Respiratory Society (ERS) Global Lung Function Initiative [Quanjer 2012]. 7. Reversibility of Disease: airway reversibility defined as ≥12% and ≥200 mL increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1. Note: If the subject does not meet the above reversibility criteria at Visit 1 then the reversibility assessment may be repeated once within 7 days of Visit 1 if either criteria a) or b) are met: 2016N271022_05 CONFIDENTIAL 205715 39 a) ≥9% increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1. b) Documented evidence of a reversibility assessment within 1 year prior to Visit 1 which demonstrated a post-bronchodilator increase in FEV1 of ≥12% and ≥200 mL. Should the subject successfully demonstrate airway reversibility (defined as ≥12% and ≥200 mL increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol) at the second attempt then, provided that all other eligibility criteria assessed at Visit 1 are met, the subject may enter the 3-week runin period (see Section 7.3.4.1). 8. Short-Acting β2 Agonists (SABAs): All subjects must be able to replace their current SABA inhaler with albuterol/salbutamol aerosol inhaler at Visit 1 as needed for the duration of the study. Subjects must be judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Fernando Holguin,  MD

Fernando Holguin, MD

Study ID

Protocol Number: 17-2041

ClinicalTrials.gov: NCT02924688

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