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

NCT ID: NCT01716520

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Umeclidinium/Vilanterol 62.5/25 mcg

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

Group Type: EXPERIMENTAL

Umeclidinium/Vilanterol 62.5/25 mcg

Intervention Type: DEVICE

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

Umeclidinium 62.5 mcg

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

Group Type: EXPERIMENTAL

Umeclidinium 62.5 mcg

Intervention Type: DEVICE

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

Vilanterol 25 mcg

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

Group Type: EXPERIMENTAL

Vilanterol 25 mcg

Intervention Type: DEVICE

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

Interventions

Umeclidinium/Vilanterol 62.5/25 mcg

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

Intervention Type: DEVICE

Umeclidinium 62.5 mcg

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

Intervention Type: DEVICE

Vilanterol 25 mcg

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
• Asthma: A current diagnosis of asthma
• Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions.
• 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.
• 12-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
• Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., ≤ 12 hours per day) is not exclusionary.
• 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Haapsalu, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Nuremberg, Bavaria, Germany

GSK Investigational Site

Potsdam, Brandenburg, Germany

GSK Investigational Site

Potsdam, Brandenburg, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Rodgau, Hesse, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Leipzg, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, Germany

GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

Countries

Estonia; Germany

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

116133

Identifier Type: -

Identifier Source: org_study_id