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AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3NCT01706328

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)

A Phase 3 study testing FF/VI 100/25 Inhalation Powder NDPI, Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS and Salbutamol as needed in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 63 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
FF/VI 100/25 Inhalation Powder NDPI, Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS and Salbutamol as needed
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
828 participants
Where
63 sitesin 5 countries
Study dates
15 Oct 2012to 17 Jun 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

63 sites in 5 countries.

63 sites in 5 countries

United States16 sites

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Normal, Illinois, 61761

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118

  • GSK Investigational Site

    Renton, Washington, 98055

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    Seneca, South Carolina, 29678

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Union, South Carolina, 29379

  • GSK Investigational Site

    Woodbury, Minnesota, 55125

Other trials in United States

Germany16 sites

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Cottbus, Brandenburg, 03050

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Dresden, Saxony, 01069

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Hamburg, 20253

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Hanover, Lower Saxony, 30173

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04207

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

Other trials in Germany

Romania13 sites

  • GSK Investigational Site

    Bacau, 600114

  • GSK Investigational Site

    Brăila, 810003

  • GSK Investigational Site

    Brasov, 500118

  • GSK Investigational Site

    Brasov, 500283

  • GSK Investigational Site

    Bucharest, 030317

  • GSK Investigational Site

    Bucharest, 70000

  • GSK Investigational Site

    Cluj-Napoca, 400371

  • GSK Investigational Site

    Iași, 700115

  • GSK Investigational Site

    Piteşti, 110084

  • GSK Investigational Site

    Ploieşti, 100379

  • GSK Investigational Site

    Râmnicu Vâlcea, 240564

  • GSK Investigational Site

    Suceava, 720284

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

Russia13 sites

  • GSK Investigational Site

    Chelyabinsk, 454106

  • GSK Investigational Site

    Kemerovo, 650000

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Kursk, 305035

  • GSK Investigational Site

    Novosibirsk, 630051

  • GSK Investigational Site

    Novosibirsk, 630102

  • GSK Investigational Site

    Perm, 614077

  • GSK Investigational Site

    Saint Petersburg, 194291

  • GSK Investigational Site

    Saint Petersburg, 194356

  • GSK Investigational Site

    Saint Petersburg, 195271

  • GSK Investigational Site

    Ulyanovsk, 432063

  • GSK Investigational Site

    Vladivostok, 690002

  • GSK Investigational Site

    Yaroslavl, 150003

Other trials in Russia

Ukraine5 sites

  • GSK Investigational Site

    Kharkiv, 61035

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kyiv, 03038

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Kyiv, 04201

Other trials in Ukraine

About this study

Official title: A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile 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)

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.

Read more

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.

Being tested
FF/VI 100/25 Inhalation Powder NDPI, Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS, Placebo Inhalation Powder NDPI, Placebo Inhalation Powder ACCUHALER/DISKUS, Salbutamol as needed
Keywords
Vilanterol (VI), Novel Dry Powder Inhaler (NDPI), FEV1, Fluticasone Furoate (FF), COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FF/VI 100/25 Inhalation Powder NDPIDrug

    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.

  • Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUSDrug

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

    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 NDPIDrug

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

    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.

  • Placebo Inhalation Powder ACCUHALER/DISKUSDrug

    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 neededDrug

    Salbutamol inhalation powder

Study groups in NCT01706328
Study groupRoleWhat they receive
FF/VI Inhalation Powder NDPIExperimentalSubjects 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.
Receives: Drug: FF/VI 100/25 Inhalation Powder NDPI; Drug: Placebo Inhalation Powder ACCUHALER/DISKUS; Drug: Salbutamol as needed
Fluticasone Propionate/Salmeterol Inhalation PowderActive comparatorSubjects 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.
Receives: Drug: Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS; Drug: Placebo Inhalation Powder NDPI; Drug: Salbutamol as needed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline Trough in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) on Treatment Day 84

    FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements taken at 5, 15, 30, and 60 minutes and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. The weighted mean was derived by calculating the area under curve, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measurements on Day 84 minus the Baseline trough FEV1 value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.

    Measured: Baseline and Day 84

Secondary outcomes (2)

  1. Time to Onset on Treatment Day 1

    Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1 during the 0- to 4-hour serial measurements (5, 15, 30, 60, 120, and 240 minutes post-dose). Participants who never met or exceeded a 100 mL increase over the Baseline value during the 4-hour serial measurements were censored at the actual time of their last FEV1 measurement.

    Measured: Baseline and Day 1

  2. Change From Baseline in Trough FEV1 on Treatment Day 85

    FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline trough was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.

    Measured: Baseline and Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2012 (estimated)
  2. Study start15 Oct 2012
  3. Primary completion17 Jun 2013
  4. Study completion17 Jun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
828 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01706328
Sponsor's protocol ID
116974
Status last verified
Apr 2018
First submitted
11 Oct 2012
Last updated
2 May 2018
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 24998880

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FF/VI 100/25 Inhalation Powder NDPI, Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS and Salbutamol as needed in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 63 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Germany, Romania, Russia, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline Trough in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) on Treatment Day 84 (time frame: Baseline and Day 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01706328, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.

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