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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00452699 |
This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID and Fluticasone propionate 250 mcg BID |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
Official Title: | A 52-Week, Randomized, Double-Blind, Parallel-Group Study of Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 Mcg BID and Fluticasone Propionate (FP) DISKUS 250 Mcg BID in Treatment of Subjects With Asthma |
Estimated Enrollment: | 600 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A female is eligible to enter and participate in the study if she is:
of child-bearing potential but has a negative urinary pregnancy test at Screening (Visit 1 and when specified in Appendix 1) and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study.
Acceptable methods of contraception [Hatcher, 2004] are:
- Abstinence
double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent
The major symptoms of asthma are episodes of dyspnea, wheezing, and cough, which may vary from mild and almost undetectable to severe and unremitting (status asthmaticus). The primary physiological manifestation of this hyperresponsiveness is variable airway obstruction. This can take the form of spontaneous fluctuations in the severity of obstruction, substantial improvements in the severity of obstruction following bronchodilators or corticosteroids, or increased obstruction caused by drugs or other stimuli [American Thoracic Society, 1987].
1) Asthma Medication History: A subject must be using a low to medium dose of an ICS (Table 1) OR a combination of controller medications (Table 2), containing a low (total daily) dose ICS (as defined in Table
1) for at least 4 weeks preceding screening.
Table 1 (ICS Dosage Table) Inhaled Corticosteroid (Dosage (mcg/day))(LowMedium) Beclomethasone dipropionate CFC(168 = 504> 504 = 840) Beclomethasone dipropionate HFA (80 = 240>240 = 640) Triamcinolone acetonide(400 = 1000>1000 = 2000) Flunisolide (500 = 1000> 1000 = 2000) Fluticasone propionate inhalation aerosol (176 = 220> 220 = 440) Fluticasone propionate inhalation powder (100 = 250> 250 = 500) Budesonide1 (200 = 600> 600 =1200) Mometasone (200 = 400> 400 = 800) Ciclesonide (80 = 160>160 = 320)
1.Respules are allowed at a dosage of 250-500mcg/day.
Table 2 (Asthma Controller Medications) Asthma Controller Medication(s) Low dose ICS + Leukotriene modifiers Low dose ICS + Theophylline products Low Dose ICS + Inhaled anticholinergics or combination products (e.g., Atrovent or Combivent) Low Dose ICS + Long acting inhaled anticholinergic (e.g. Spiriva) Low dose ICS+ long acting beta agonist or combination products containing a low dose ICS and a long-acting beta-agonists (e.g. ADVAIR™/SERETIDE™1 100/50 mcg BID or Symbicort 160/9 mcg BID (i.e 80/4.5 mcg two inhalations BID)
1) ADVAIR/SERETIDE =250/50 mcg BID or Symbicort 320/9 mcg BID (i.e 160/4.5 mcg two inhalation BID) are not permitted.
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
The list of excluded conditions/diseases includes, but is not limited to:
congestive heart failure known aortic aneurysm clinically significant coronary clinically significant cardiac arrhythmia heart disease stroke within 3 months of screening (Visit 1) uncontrolled hypertension coronary artery disease hematologic, hepatic, or renal disease cystic fibrosis poorly controlled peptic ulcer dyspnea by any other cause than asthma gastroesophageal reflux disease (GERD) not controlled by pharmacotherapy and may be causing/contributing to subject's respiratory symptoms thyrotoxicosis hypokalemia immunologic compromise current malignancy1 tuberculosis (current or quiescent) Cushing's or Addison's disease pneumonia, pneumothorax, chronic bronchitis or atelectasis uncontrolled diabetes mellitus recent history of drug or alcohol abuse 1) history of malignancy is acceptable only if subject has been in remission for one year prior to screening (Visit 1; remission = no treatment for the malignancy in the 12 months prior to screening [Visit 1])
- Drug Allergy: A subject must not have had any immediate or delayed hypersensitivity to any beta2-agonist; sympathomimetic drug; any intranasal; inhaled or systemic corticosteroid therapy; lactose; or have a severe milk protein allergy.
Medication (Exclusion Period Prior to screening (Visit 1)) Oral or parenteral systemic corticosteroids (4 weeks) Omalizumab (Xolair) (6 months)
Concurrent Medications: A subject must not have the concurrent use of any of the following medications that interact with any of the study drugs used in this study, or that may affect the course of asthma or interact with sympathomimetic amines, such as: - beta-adrenergic receptor blocking agents
- monoamine oxidase (MAO) inhibitors
- tricyclic antidepressants
- ritonavir
Tobacco Use: >10 pack year history or use of any tobacco products within 1 year of screening (Visit 1).
This includes cigarettes, cigars, pipe, chewing tobacco, and snuff.
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ADA109055 |
Study First Received: | March 26, 2007 |
Last Updated: | May 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00452699 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; United States: Food and Drug Administration |
Asthma long-term study ADVAIR 250 |
FLOVENT 250 Salmeterol fluticasone propionate |
Anti-Inflammatory Agents Neurotransmitter Agents Salmeterol Bronchial Diseases Adrenergic Agents Adrenergic beta-Agonists Anti-Asthmatic Agents Asthma Anti-Allergic Agents Adrenergic Agonists |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Fluticasone Dermatologic Agents |
Salmeterol Adrenergic beta-Agonists Immune System Diseases Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |