Advair HFA For Chronic Obstructive Pulmonary Disease(COPD)

NCT ID: NCT00633217

Last Updated: 2016-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-02-28

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

Study Design

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

Study Groups

arm 1

Group Type: ACTIVE_COMPARATOR

Fluticasone Propionate/Salmeterol DISKUS 250/50mcg

Intervention Type: DRUG

treatment drug

arm 2

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

treatment drug

Interventions

Fluticasone Propionate/Salmeterol DISKUS 250/50mcg

treatment drug

Intervention Type: DRUG

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

treatment drug

Intervention Type: DRUG

Other Intervention Names

Fluticasone Propionate/Salmeterol DISKUS 250/50mcg

Eligibility Criteria

Inclusion Criteria

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:

1. 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,

2. 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].

• A post-albuterol FEV1/FVC ratio of ≤ 0.70
• A post-albuterol FEV1 ≥ 0.70L and ≤ 70% of predicted normal OR a post-albuterol FEV1 of ≤ 0.70L and ≥40% of predicted normal but still ≤70% of predicted normal based on NHANES III reference values [Hankinson, 1999].
• Current or previous smokers with a cigarette smoking history of ≥ 10 pack-years. [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]. Former-smokers are defined as subjects who have discontinued smoking for ≥ 6 months prior to Visit 1. Subjects who decide to stop smoking at Visit 1 will not be eligible for participation in the study.

Exclusion Criteria

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.
• A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis), including subjects with a diagnosis of alpha-1-antitrypsin deficiency. Allergic rhinitis is not exclusionary.
• 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.
• Previously diagnosed cancer unless it is in complete clinical remission (no evidence of any tumor burden) at Visit 1. Localized carcinomas of the skin that have been resected for cure are not considered exclusionary.
• 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:

Medication (Exclusion Prior to Visit 1) Short-acting beta-agonists (e.g., albuterol) (6 hours) Ipratropium (6 hours) Ipratropium/albuterol combination product (6 hours) Oral beta-agonists (48 hours) Salmeterol and formoterol (48 hours) Theophylline preparations (48 hours) Tiotropium (48 hours) Long-acting beta-agonist/inhaled corticosteroid combination products (e.g., ADVAIR™ or Symbicort) (30 days) Inhaled corticosteroids (30 days) Oral or parenteral corticosteroids (30 days) Any investigational drug (30 days)

• 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.
• Use of nocturnal positive pressure [e.g., continuous positive airway pressure or bi-level positive airway pressure].
• A body mass index (BMI) of ≥ 40kg/m².
• Subject is a study investigator, sub-investigator, study coordinator, or employee of a participating investigator or immediate family members of the aforementioned.
• Any intellectual deficiency including illiteracy, history of substance abuse in the two years prior to Visit 1 (including drug and alcohol), or other conditions, which will limit the validity of informed consent to participate in the study.
• Supplemental oxygen, with the following exceptions:

• Use at high altitude (> 5000 feet) provided subject does not require a flow rate of > 2 L/minute
• Use for exertion provided subject does not require > 2 hours per day of oxygen and does not require a flow rate of > 2L/minute
• Use for nocturnal therapy provided subject does not require a flow rate of > 2L/minute

• 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

Jasper, Alabama, United States

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Lafayette, Louisiana, United States

GSK Investigational Site

New Orleans, Louisiana, United States

GSK Investigational Site

Sunset, Louisiana, United States

GSK Investigational Site

Saint Charles, Missouri, United States

GSK Investigational Site

Elizabeth City, North Carolina, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Gaffney, South Carolina, United States

GSK Investigational Site

Greenville, South Carolina, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

Union, South Carolina, United States

GSK Investigational Site

Corsicana, Texas, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Morgantown, West Virginia, United States

Countries

Argentina; United States

References

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.

Reference Type: BACKGROUND

PMID: 21253451 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Dataset Specification

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

111117

Identifier Type: -

Identifier Source: org_study_id