Efficacy and Safety of the Addition of Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide Inhalation Powder (62.5 or 125mcg) Once-daily Over 12 Weeks.

NCT01772147 | Completed Phase 3 Results

• 1 other identifier: 116136
• Study Type: interventional
• Target: 608
• Locations: 5 countries
• Sites: 55

Brief Summary

The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85

  FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline, and day by treatment interactions.

  Baseline and Day 85

Secondary Outcomes (3)

• Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84

  Baseline and Day 84

• Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12

  Baseline and Weeks 1- 12

• Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12

  Baseline and Weeks1- 12

Study Arms (2)

Umeclidinium bromide

EXPERIMENTAL

Long-acting muscarinic antagonist (LAMA)

Drug: Umeclidinium bromide 62.5mcg; Drug: Umeclidinium bromide 125mcg

Fluticasone propionate/Salmeterol

ACTIVE COMPARATOR

Inhaled corticosteroid (ICS)/Long-acting beta agonist (LABA)

Drug: Fluticasone propionate 250mcg/Salmeterol 50mcg

Interventions

Umeclidinium bromide 62.5mcg DRUG

Inhalation powder

Umeclidinium bromide

Umeclidinium bromide 125mcg DRUG

Inhalation powder

Umeclidinium bromide

Fluticasone propionate 250mcg/Salmeterol 50mcg DRUG

Inhalation powder

Fluticasone propionate/Salmeterol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type of subject: Outpatient.
• Informed Consent: A signed and dated written informed consent prior to study participation.
• Age: Subjects 40 years of age or older at Visit 1.
• Gender: Male or female subjects. A female is eligible to enter and participate if of non-child-bearing potential, or if of child bearing potential, has a megative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in the protocol, used consistently and correctly.
• Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.
• Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years \[number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)\]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history.
• Severity of Disease: A pre and post-albuterol/salbutamol FEV1/FVC ratio of \<0.70 and a pre and post-albuterol/salbutamol FEV1 of ≤70% of predicted normal values at Visit 1 (Screening) calculated using Nutrition Health and Examination Survey (NHANES) III reference equations.
• Dyspnea: A score of ≥2 on the mMRC Dyspnea Scale at Visit 1.

You may not qualify if:

• Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
• Asthma: A current diagnosis of asthma.
• Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate, or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholingeric.
• Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
• Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1.
• Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Specific ECG findings that preclude subject eligibility are listed in Appendix 4. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 4.
• Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
• Medications Prior to Screening: use of certain medications for the protocol-specific times prior to Visit 1.
• Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy.
• Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
• Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
• Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, subinvestigator, study coordinator, or employee of the participating investigator.
• Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (55)

GSK Investigational Site

Mobile, Alabama, 36608, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85006, United States

Location

GSK Investigational Site

Huntington Beach, California, 92647, United States

Location

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

Orlando, Florida, 32822, United States

Location

GSK Investigational Site

Tampa, Florida, 33603, United States

Location

GSK Investigational Site

Coeur d'Alene, Idaho, 83814, United States

Location

GSK Investigational Site

Sunset, Louisiana, 70584, United States

Location

GSK Investigational Site

Saint Charles, Missouri, 63301, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28207, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45245, United States

Location

GSK Investigational Site

Rock Hill, South Carolina, 29732, United States

Location

GSK Investigational Site

Seneca, South Carolina, 29678, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Newport News, Virginia, 23606, United States

Location

GSK Investigational Site

Richmond, Virginia, 23229, United States

Location

GSK Investigational Site

Richmond, Virginia, 23249, United States

Location

GSK Investigational Site

Viña del Mar, Región de Valparaíso, 2520024, Chile

Location

GSK Investigational Site

Viña del Mar, Región de Valparaíso, Chile

Location

GSK Investigational Site

Concepción, Región Del Biobio, 4070038, Chile

Location

GSK Investigational Site

Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7500710, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7500800, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 8880465, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Location

GSK Investigational Site

Talca, Región Metro de Santiago, 3460001, Chile

Location

GSK Investigational Site

Karlovy Vary, 360 09, Czechia

Location

GSK Investigational Site

Kralupy nad Vltavou, 278 01, Czechia

Location

GSK Investigational Site

Lovosice, 410 02, Czechia

Location

GSK Investigational Site

Olomouc, 772 00, Czechia

Location

GSK Investigational Site

Ostrava - Poruba, 70868, Czechia

Location

GSK Investigational Site

Pilsen, 301 00, Czechia

Location

GSK Investigational Site

Pilsen, 323 00, Czechia

Location

GSK Investigational Site

Prague, 140 46, Czechia

Location

GSK Investigational Site

Prague, 150 00, Czechia

Location

GSK Investigational Site

Prague, 170 00, Czechia

Location

GSK Investigational Site

Tábor, 390 19, Czechia

Location

GSK Investigational Site

Teplice, 415 10, Czechia

Location

GSK Investigational Site

Elblag, 82-300, Poland

Location

GSK Investigational Site

Gdynia, 81-384, Poland

Location

GSK Investigational Site

Grudziądz, 86-300, Poland

Location

GSK Investigational Site

Inowrocław, 88-100, Poland

Location

GSK Investigational Site

Krakow, 31-024, Poland

Location

GSK Investigational Site

Ostrów Wielkopolski, 63-400, Poland

Location

GSK Investigational Site

Piła, 64-920, Poland

Location

GSK Investigational Site

Warsaw, 01-192, Poland

Location

GSK Investigational Site

Wroclaw, 50-088, Poland

Location

GSK Investigational Site

Daegu, 705-717, South Korea

Location

GSK Investigational Site

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 130-848, South Korea

Location

GSK Investigational Site

Seoul, 134-701, South Korea

Location

GSK Investigational Site

Seoul, 143-729, South Korea

Location

GSK Investigational Site

Seoul, 152-703, South Korea

Location

GSK Investigational Site

Seoul, 158-710, South Korea

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 21, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 23, 2017
• Results First Posted: April 21, 2014

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

CZ (12); US (17); CL (9); PL (9); KR (8)