A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01706328

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 828 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-15
• Study Completion Date: 2013-06-17

Brief Summary

This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subjects.

Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to evaluate the subject's adherence with study treatment, study procedures and assessment of disease stability.

At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the Randomization Criteria will be randomized to double-blind study medication (12-week treatment period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1 inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return to the clinic at the end of the treatment period.

A follow-up phone contact will be performed approximately 7 days after the last clinic visit. The overall study duration (Screening to Follow-up) for each subject is approximately 15 weeks.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FF/VI Inhalation Powder NDPI

Subjects randomized to the FF/VI 100/25 arm will take an active inhalation of study medication during their morning dosing from their NDPI and will have an inhalation of dummy medication (placebo) as their morning ACCUHALER/DISKUS dose and as their evening dose.

Group Type: EXPERIMENTAL

FF/VI 100/25 Inhalation Powder NDPI

Intervention Type: DRUG

Subjects randomized to the FF/VI Inhalation Powder Novel Dry Powder Inhaler (NDPI) arm will receive a single inhalation of 100 mcg FF and 25 mcg VI via NDPI every morning for 12 weeks.

Placebo Inhalation Powder ACCUHALER/DISKUS

Intervention Type: DRUG

Subjects randomized to the FF/VI Inhalation Powder NDPI arm will receive a single inhalation of placebo inhalation powder via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks.

Salbutamol as needed

Intervention Type: DRUG

Salbutamol inhalation powder

Fluticasone Propionate/Salmeterol Inhalation Powder

Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg arm will have an active dose of medication during both their morning and evening treatments from the ACCUHALER/DISKUS and a dummy placebo dose in the morning from their NDPI.

Group Type: ACTIVE_COMPARATOR

Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS

Intervention Type: DRUG

Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of 250 mcg Fluticasone Propionate and 50 mcg Salmeterol via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks.

Placebo Inhalation Powder NDPI

Intervention Type: DRUG

Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of placebo inhalation powder via NDPI every morning for 12 weeks.

Salbutamol as needed

Intervention Type: DRUG

Salbutamol inhalation powder

Interventions

FF/VI 100/25 Inhalation Powder NDPI

Subjects randomized to the FF/VI Inhalation Powder Novel Dry Powder Inhaler (NDPI) arm will receive a single inhalation of 100 mcg FF and 25 mcg VI via NDPI every morning for 12 weeks.

Intervention Type: DRUG

Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS

Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of 250 mcg Fluticasone Propionate and 50 mcg Salmeterol via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks.

Intervention Type: DRUG

Placebo Inhalation Powder NDPI

Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of placebo inhalation powder via NDPI every morning for 12 weeks.

Intervention Type: DRUG

Placebo Inhalation Powder ACCUHALER/DISKUS

Subjects randomized to the FF/VI Inhalation Powder NDPI arm will receive a single inhalation of placebo inhalation powder via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks.

Intervention Type: DRUG

Salbutamol as needed

Salbutamol inhalation powder

Intervention Type: DRUG

Other Intervention Names

ACCUHALER and DISKUS are registered trade marks of the GlaxoSmithKline Group of companies; ACCUHALER and DISKUS are registered trade marks of the GlaxoSmithKline Group of companies

Eligibility Criteria

Inclusion Criteria

• A male or female >=40 years of age at Screening (Visit 1).
• Capable of giving written informed consent.
• Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy.
• Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society.
• Subject with a measured post-albuterol (salbutamol) FEV1/forced vital capacity(FVC) ratio of <=0.70 at Screening.
• Subjects with a measured post-albuterol (salbutamol) FEV1 <=70% of predicted normal values.
• Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening.

Exclusion Criteria

• Current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
• Other respiratory disorders (alpha1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases).
• Lung volume reduction surgery within the 12 months prior to Screening.
• Hospitalized due to poorly controlled COPD within 12 weeks of Screening.
• Poorly controlled COPD (occurrence of the following in the 6 weeks prior to Screening -Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician).
• Lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Screening.
• Moderate/severe COPD exacerbation/lower respiratory tract infection during Run-In Period.
• Abnormal and clinically significant 12-lead ECG at Screening
• Historical or current evidence of uncontrolled or clinically significant disease like cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
• History of hypersensitivity to any of the study medications or components of the inhalation powder; or history of severe milk protein allergy.
• Known or suspected history of alcohol or drug abuse within the last 2 years.
• Subjects who are medically unable to withhold their albuterol (salbutamol) and/or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit.
• The subject has taken any other investigational drug within 30 days or 5 half-lives of the investigational product (IP) prior to the first dosing day in the current study.
• Use of additional medications prior to Screening (list of medications and time intervals are different for different class of medications and are indicated in the protocol)
• Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., <=12 hours per day) is not exclusionary.
• Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening
• Subjects at risk of non-compliance, or unable to comply with study procedures.
• Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
• Women who are pregnant or lactating or are planning on becoming pregnant during the study.
• Previously randomized to either the HZC113109 or HZC112352 clinical studies.

• 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

Clearwater, Florida, United States

GSK Investigational Site

DeLand, Florida, United States

GSK Investigational Site

Coeur d'Alene, Idaho, United States

GSK Investigational Site

Normal, Illinois, United States

GSK Investigational Site

Woodbury, Minnesota, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Easley, South Carolina, United States

GSK Investigational Site

Gaffney, South Carolina, United States

GSK Investigational Site

Greenville, South Carolina, United States

GSK Investigational Site

Orangeburg, South Carolina, United States

GSK Investigational Site

Rock Hill, South Carolina, United States

GSK Investigational Site

Seneca, South Carolina, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

Union, South Carolina, United States

GSK Investigational Site

Renton, Washington, United States

GSK Investigational Site

Cottbus, Brandenburg, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Neu-Isenburg, Hesse, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Delitzsch, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Leipzg, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Bacau, , Romania

GSK Investigational Site

Brasov, , Romania

GSK Investigational Site

Brasov, , Romania

GSK Investigational Site

Brăila, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Cluj-Napoca, , Romania

GSK Investigational Site

Iași, , Romania

GSK Investigational Site

Piteşti, , Romania

GSK Investigational Site

Ploieşti, , Romania

GSK Investigational Site

Râmnicu Vâlcea, , Romania

GSK Investigational Site

Suceava, , Romania

GSK Investigational Site

Timișoara, , Romania

GSK Investigational Site

Chelyabinsk, , Russia

GSK Investigational Site

Kemerovo, , Russia

GSK Investigational Site

Kemerovo, , Russia

GSK Investigational Site

Kursk, , Russia

GSK Investigational Site

Novosibirsk, , Russia

GSK Investigational Site

Novosibirsk, , Russia

GSK Investigational Site

Perm, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Ulyanovsk, , Russia

GSK Investigational Site

Vladivostok, , Russia

GSK Investigational Site

Yaroslavl, , Russia

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kiev, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

Countries

United States; Germany; Romania; Russia; Ukraine

References

Dransfield MT, Feldman G, Korenblat P, LaForce CF, Locantore N, Pistolesi M, Watkins ML, Crim C, Martinez FJ. Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients. Respir Med. 2014 Aug;108(8):1171-9. doi: 10.1016/j.rmed.2014.05.008. Epub 2014 Jun 19.

Reference Type: DERIVED

PMID: 24998880 (View on PubMed)

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: Annotated Case Report Form

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: Informed Consent Form

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: Dataset Specification

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

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

116974

Identifier Type: -

Identifier Source: org_study_id