Asthma
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Consent: A signed and dated written informed consent must be obtained from the subject and/or subject's legally acceptable representative prior to study participation. 2.Type of Subject: Outpatient 3.Gender: Male or female Females are eligible to participate only if they are currently non-pregnant and non-lactating. A female is eligible to enter and participate in the study if she is: a. of non-child-bearing potential; OR b. 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 - oral contraceptive (either combined or progestogen only) - injectable progestogen - implants of levonorgestrel - estrogenic vaginal ring - percutaneous contraceptive devices - intrauterine device (IUD) or intrauterine system (IUS) with published data showing that the lowest expected failure rate is less than 1% per year - male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject - double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent 1. Age: A subject must be 12 years of age at Visit 1 (screening). 2. Asthma Diagnosis: A documented diagnosis of persistent asthma, for at least six months, as defined by the following American Thoracic Society definition: Asthma is a clinical syndrome characterized by increased responsiveness of the airways to a variety of stimuli. 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. 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 lon
Exclusion criteria
Exclusion criteria: 1.Life-Threatening Asthma: A subject must not have life-threatening asthma. Life-threatening asthma is defined for this protocol as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures, or asthma-related syncopal episode(s) within the 12 months prior to screening (Visit 1). 2.Worsening of Asthma: A subject must not have experienced a worsening of asthma which involved an ER visit, hospitalization or use of oral/parenteral corticosteroids within 4 weeks of screening (Visit 1). 3.Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent or seasonal or exercise-induced asthma are excluded from participation in this study. 4.Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma. 5.Concurrent Conditions/Diseases: A subject with historical or current evidence of any clinically significant, co-morbid or uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was to demonstrate that FSC DISKUS 250/50 BID is superior to FP DISKUS 250 BID at increasing pulmonary function as measured by forced expiratory volume in one second (FEV1) over a 52-week treatment period.;Secondary Objective: Secondary objectives were to compare the efficacy of the two treatment groups with respect to the following parameters: morning (AM) peak expiratory flow (PEF), percent of symptom-free days, and the incidence of asthma attacks. ;Primary end point(s): Mean change from baseline in pre-dose FEV1 over Weeks 1-52;Timepoint(s) of evaluation of this end point: Weeks 1-52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Morning peak flow; percentage of symptom free days; asthma attack rate •Morning peak flow (AM PEF) Percentage of symptom-free days Asthma attack rate (per subject per year) •Comparison of improvement in lung function as measured by FEV1 between ADVAIR DISKUS 250/50 mcg BID vs FLOVENT DISKUS mcg BID over 52 weeks ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed