Cross-Over Study in Subjects With COPD, Evaluating Lung Function Response After Treatment With Once Daily Umeclidinium 62.5mcg, Vilanterol 25mcg, and Umeclidinium/Vilanterol 62.5/25mcg

NCT01716520 | Completed Phase 3 Results

• 1 other identifier: 116133
• Study Type: interventional
• Target: 182
• Locations: 2 countries
• Sites: 21

Brief Summary

The purpose of this study is to evaluate the lung function response to UMEC/VI, UMEC, and VI in individual patients using a cross-over design. This is a multicenter, randomized, double-blind, 3-way crossover study. Eligible subjects will be randomized to a sequence of UMEC 62.5mcg, VI 25mcg, and UMEC/VI 62.5/25mcg. All subjects will receive each treatment once-daily for 14 days, and each treatment will be separated by a 10-14 day washout period. There will be a 5-7 day run-in period prior to randomization.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

long-acting muscarinic antagonist; long-acting beta-agonist; Chronic Obstructive Pulmonary Disease; vilanterol; umeclidinium

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type

  FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 \[mean of the 23 and 24 hour assessments post Day 13 dosing\]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP. Participants could have been classified as responders to both UMEC and VI.

  Baseline and Day 14 of each treatment period (up to study day 83)

Secondary Outcomes (3)

• Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC, or VI According to FEV1 at Day 1 of Each Treatment Period (TP)

  Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 71)

• Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone

  Baseline and Day 14 of each treatment period (up to study day 83)

• Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period

  Baseline and Day 15 of each treatment period (up to study day 84)

Study Arms (3)

Umeclidinium/Vilanterol 62.5/25 mcg

EXPERIMENTAL

Umeclidinium/Vilanterol 62.5/25 mcg once daily in the morning via novel dry powder inhaler (NDPI)

Device: Umeclidinium/Vilanterol 62.5/25 mcg

Umeclidinium 62.5 mcg

EXPERIMENTAL

Umeclidinium 62.5 mcg once daily in the morning via novel dry powder inhaler (NDPI)

Device: Umeclidinium 62.5 mcg

Vilanterol 25 mcg

EXPERIMENTAL

Vilanterol 25 mcg once daily in the morning via novel dry powder inhaler (NDPI)

Device: Vilanterol 25 mcg

Interventions

Umeclidinium/Vilanterol 62.5/25 mcg DEVICE

Umeclidinium/Vilanterol 62.5/25 mcg once daily in the morning via novel dry powder inhaler (NDPI)

Umeclidinium/Vilanterol 62.5/25 mcg

Umeclidinium 62.5 mcg DEVICE

Umeclidinium 62.5 mcg once daily in the morning via novel dry powder inhaler (NDPI)

Umeclidinium 62.5 mcg

Vilanterol 25 mcg DEVICE

Vilanterol 25 mcg once daily in the morning via novel dry powder inhaler (NDPI)

Vilanterol 25 mcg

Eligibility Criteria

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

You may qualify if:

• Type of Patient: 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.
• COPD diagnosis: As defined by the American Thoracic Society/European Respiratory Society (ATS/ERS)
• Severity of disease: A pre- and post-salbutamol FEV1/FVC ratio of \<0.70 and a pre- and post-salbutamol FEV1 of ≤ 70% of predicted normal values at Visit 1
• Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years at Visit 1
• Female subject of non child-bearing potential OR a female subject of child bearing potential, with a negative pregnancy test at screening, and agreeing to consistently and correctly use one of the acceptable contraceptive methods

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
• Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for \< 5 years prior to Visit 1
• Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as of 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 anticholinergic.
• 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
• Screening Labs: Significantly abnormal finding from clinical chemistry or hematology tests at Visit 1 as determined by the study investigator.
• Medication Prior to Spirometry: Unable to withhold salbutamol for the 4 hour period required prior to spirometry testing at each study visit and at each spirometry test performed at home.
• Medications Prior to Screening: Use of the prohibited medications according to defined time intervals prior to Visit 1
• Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol, ipratropium bromide) 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: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study.
• 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 (21)

GSK Investigational Site

Haapsalu, 90502, Estonia

Location

GSK Investigational Site

Tallinn, 10117, Estonia

Location

GSK Investigational Site

Tallinn, 10138, Estonia

Location

GSK Investigational Site

Tallinn, 13619, Estonia

Location

GSK Investigational Site

Tartu, 51014, Estonia

Location

GSK Investigational Site

Munich, Bavaria, 80339, Germany

Location

GSK Investigational Site

Nuremberg, Bavaria, 90402, Germany

Location

GSK Investigational Site

Potsdam, Brandenburg, 14467, Germany

Location

GSK Investigational Site

Potsdam, Brandenburg, 14469, Germany

Location

GSK Investigational Site

Hamburg, Hamburg, 20253, Germany

Location

GSK Investigational Site

Rodgau, Hesse, 63110, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30173, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Leipzg, Saxony, 04109, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

GSK Investigational Site

Lübeck, Schleswig-Holstein, 23552, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10367, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13086, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13581, Germany

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

Condition Hierarchy (Ancestors)

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

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 30, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 9, 2017
• Results First Posted: February 11, 2014

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (5); DE (16)