Advair HFA For Chronic Obstructive Pulmonary Disease(COPD)

NCT00633217 | Completed Phase 4 Results

• 1 other identifier: 111117
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 16

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of the FSC HFA MDI in subjects with COPD. The dose of FSC HFA MDI to be evaluated corresponds to the dose of FSC DISKUS (250/50mcg twice-daily) that is indicated for the treatment of COPD associated with chronic bronchitis in the US. This study will last up to approximately 15 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests and will record their peak expiratory flow measurements daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The FSC HFA MDI used in this study has been approved by FDA for use in asthma while the FSC 250/50mcg DISKUS has been approved for use in asthma and COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

DISKUS; Salmeterol; Fluticasone Propionate; Chronic Obstructive Pulmonary Disease (COPD); Hydroflouroalkane; COPD; HFA MDI

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug

  The primary efficacy analysis was mean change from baseline in 2-hour post-dose FEV1 compared between the two treatment groups at Endpoint. Change from baseline was calculated as the value at Endpoint minus the baseline value. FEV1, which is assessed using spirometry, is the maximal amount of air you can forcefully exhale in one second. Endpoint was defined as the last scheduled observation for 2 hour post-dose FEV1 during the 12-week treatment period.

  2 hours after administration of blinded study drug; Baseline through Week 12

Secondary Outcomes (2)

• Mean Change From Baseline in AM Pre-dose FEV1

  Measurement of FEV1 prior to study drug administration; Baseline through Week 12

• Mean Change From Baseline in Peak Expiratory Flow

  Baseline through Week 12

Study Arms (2)

arm 1

ACTIVE COMPARATOR

Drug: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg

arm 2

EXPERIMENTAL

Drug: Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg

Interventions

Fluticasone Propionate/Salmeterol DISKUS 250/50mcg DRUG

treatment drug

arm 1

Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg DRUG

treatment drug

Also known as: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg

arm 2

Eligibility Criteria

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

You may qualify if:

• Subjects eligible for enrollment in the study must meet all of the following criteria:
• Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation.
• Males or females ≥ 40 years of age.
• A female is eligible to participate in this study if she is of:
• non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal \[i.e., \>1 year without menses in the absence of hormone replacement therapy\]); or,
• child-bearing potential, has a negative pregnancy test (urine) at screen, and one of the following applies:
• Abstinence from intercourse, or,
• Male partner was sterile prior to the female subject's entry into the study, or,
• Use of implants of levonorgestrel; or,
• Injectable progesterone; or,
• Oral contraceptive (combined or progesterone only), contraceptive patch, vaginal ring; or,
• Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (e.g., Paragard), or,
• Double barrier technique simultaneously using two of the following: spermicide, male condom, diaphragm, or female condom
• An established clinical history of COPD (including chronic bronchitis and/or emphysema) in accordance with the following definition by the American Thoracic Society:
• COPD is a preventable and treatable disease state characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences \[Celli, 2004\].

You may not qualify if:

• Subjects meeting any of the following criteria must not be enrolled in the study:
• A current diagnosis of asthma.
• Any clinically significant and uncontrolled disease, including but not limited to the following: neurological, psychiatric, renal, immunological, endocrine/metabolic (including uncontrolled diabetes, hypokalemia or thyroid disease), cardiovascular, neuromuscular, hepatic, gastric, or hematological abnormalities, or peripheral vascular disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would affect the efficacy analysis if the disease/condition exacerbated during the study.
• An abnormal and clinically significant chest x-ray or computed tomography (CT) scan not believed to be due to the presence of COPD. A chest x-ray must be taken if the subject has not had one within 6 months of Visit 1.
• An abnormal and clinically significant 12-lead electrocardiogram (ECG). For the purposes of this study, an abnormal ECG is defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following:
• Myocardial ischemia
• Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome)
• Clinically significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia) The study investigator will determine the clinical significance of any ECG abnormality and determine if a subject is precluded from entering the study.
• Any immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or intranasal, inhaled, or oral corticosteroid including any components of the formulations (e.g. lactose or milk protein).
• Initiation of systemic beta-blocker medications within 30 days of Visit 1.
• Use of products containing the protease inhibitor ritonavir (Norvir, Kaletra).
• Use of the following medications within the defined times prior to Visit 1:
• Lung resection surgery (e.g., lung volume reduction surgery, or lobectomy) within 1 year of Visit 1.
• A COPD exacerbation and/or infection of the upper or lower respiratory tract requiring treatment with systemic (oral or parenteral) corticosteroids and/or antibiotics that has not resolved within 30 days of Visit 1
• A COPD exacerbation that resulted in hospitalization that has not resolved within 3 months of Visit 1.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (16)

GSK Investigational Site

Jasper, Alabama, 35501, United States

Location

GSK Investigational Site

Mobile, Alabama, 36608, United States

Location

GSK Investigational Site

Lafayette, Louisiana, 70503, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70115, 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

Elizabeth City, North Carolina, 27909, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16508, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29406-7108, United States

Location

GSK Investigational Site

Gaffney, South Carolina, 29340, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Union, South Carolina, 29309, United States

Location

GSK Investigational Site

Corsicana, Texas, 75110, United States

Location

GSK Investigational Site

Richmond, Virginia, 23229, United States

Location

GSK Investigational Site

Morgantown, West Virginia, 26505, United States

Location

Related Publications (1)

• Koser A, Westerman J, Sharma S, Emmett A, Crater GD. Safety and efficacy of fluticasone propionate/salmeterol hydrofluoroalkane 134a metered-dose-inhaler compared with fluticasone propionate/salmeterol diskus in patients with chronic obstructive pulmonary disease. Open Respir Med J. 2010 Oct 21;4:86-91. doi: 10.2174/1874306401004010086.

  PMID: 21253451 BACKGROUND

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

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

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: March 11, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 8, 2016
• Results First Posted: November 26, 2009

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (16)