Persistent asthma
Conditions
Interventions
Product Code: GW685698X DISKUS
Pharmaceutical Form: Inhalation powder
Current Sponsor code: GW685698X
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Current S
Sponsors
GlaxoSmithKline Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Type of Subject: Outpatient 2.Age: 12 years of age or older at Visit 1 (or =18 years of age or older if local regulations or the regulatory status of study medication permit enrollment of adults only). 3.Gender: Male or Eligible Female To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by Section 5.2.1 of the protocol. A serum pregnancy test is required for all females. This test will be performed at the initial screening visit (Visit 1) and Visit 7. In addition, a urine pregnancy test on the morning of the double-blind treatment visits, prior to randomization, (Visit 2) and at Visits 3 through 6. 4.Asthma Diagnosis: Asthma as defined by the National Institutes of Health [National Institutes of Health, 2002]. 5.Severity of Disease: A best FEV1 of 50% 80% of the predicted value during Visit 1 based on the "Standardization of Lung Function Tests" [European Respiratory Society, 1993] standards for 18 years and older or Polgar [Polgar, 1971] standards for 12-17 years and race adjusted for African-Americans [American Thoracic Society, 1991]. 6.Reversibility of Disease: Demonstrated a = 12% and = 200mL reversibility of FEV1 within 30-minutes following 2-4 inhalations of albuterol/salbutamol HFA inhalation aerosol (or one nebulized treatment with albuterol/salbutamol solution) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 =12% and =200mL, then the subject is not eligible for the study and will not be allowed to rescreen. 7.Current Anti-Asthma Therapy: Subjects must be using an inhaled corticosteroid for at least 3 months prior to Visit 1 and be maintained on a stable dose for four weeks prior to Visit 1 at the doses specified in the protocol section 5.2.1 8.Short-Acting Beta-2-Agonists: All subjects must be able to replace short-acting ?2-agonists with albuterol/salbutamol HFA inhalation aerosol at Visit 1 for use as needed for the duration of the study. Nebulized albuterol/salbutamol will not be allowed during the study with the exception of its use during reversibility testing at Visit 1. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to study visits. 9.Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study. 10.Compliance: Subjects must be able to comply with all the study requirements. At the end of the run-in period, a subject will be eligible to enter the treatment period of the study if he/she meets the following criteria at Visit 2: 1.Reproducibility: Morning pre-dose percent predicted FEV1 of between 50% and 80% of their predicted normal and within ±15% of the best pre-albuterol/salbutamol HFA FEV1 at Visit 1. 2.Demonstrated and reported in a daily diary, symptoms of asthma (a score of = 1 on the daytime or nighttime asthma symptom scores) on at least 4 of the last 7 consecutive days of the run-in period or daily albuterol/salbutamol HFA use must have been used on at least 4 of the last 7 consecutive days of the run-in period. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures. 2.Respiratory Infection: Cultured documented of suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1. In addition, the subject must be excluded, if such infection occurs between Visits 1 and 2. 3.Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 3 months of Visit 1. A subject must not have had any hospitalization for asthma within 6 months prior to Visit 1. 4.Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmomary disease, or other respiratory abnormatlities other than asthma 5.Other Concurrent Diseases/Abnormalities: A subjects must not have any clinically significant, uncontrolled condition or disease state, that in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study. The list of additional excluded conditions/diseases includes, but is not limited to the following: congestive heart failure, known aortic aneurysm, clinically significant coronary heart disease, clinically significant cardiac arrhythmia, stroke within 3 months of Visit 1, uncontrolled hypertension*, poorly controlled peptic ulcer, hematologic, hepatic, or renal disease, immunologic compromise, current malignancy**, tuberculosis (current or quiescent), Cushing’s disease, Addison’s disease, uncontrolled diabetes mellitus, recent history of drug or alcohol abuse *systolic BP>170, or diastolic BP >100 6.Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has an abnormal orophryngeal exam at Visit 1 (culture positive test for candidiasis) (Protocol 6.3.3) 7.Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 1 or within ten half-lives (t ½) of the prior investigational study (which ever is longer of the two) or concurrently during the study. 8.Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e. lactose or cellobiose octaacetate). 9.Milk Protein Allergy: History of severe milk protein allergy. 10.Immunosuppressive Medications: A subject must not be using, or require use, of immunosuppressive medications during the study. NOTE: Immunotherapy for the treatment of allergies is allowed during the study provided that the treatment was initiated prior to Visit 1 and the subject is maintained on a stable daily dose throughout the study period. 11Tobacco Use. A subject may not have used tobacco products within the past one year (i.e., cigarettes, cigars, or pipe tobacco) or have historical use of >10 pack years (e.g. 20 cigarettes/day for 10 years). 12. Corticosteroid Use: Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1. 13.Potent Cytochrome P450 34A (CYP34A) inhibitors: Patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the dose response, efficacy and safety of four dosage regimens of GW685698X (100mcg, 200mcg, 300mcg and 400mcg) administered once daily in the morning in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma to effectively select the optimum dose of GW685698X for use in further clinical studies of this population. Clinic lung function will be recorded using change in FEV1 from baseline. ;Secondary Objective: To study asthma symptoms (frequency and time of), and requirement for rescue medication in subjects taking GW685698X as recorded by each subject in the daily diary card. Daily changes in lung function will be studied by the subject recording PEF each morning and evening in the diary card.;Primary end point(s): The primary efficacy measure will be the mean change from baseline to the end of the 8-week treatment period (last assessment on treatment using last observation carried forward) in trough (AM pre-dose and pre-rescue bronchodilator) FEV1. | — |
Countries
Estonia, Latvia, Lithuania
Outcome results
None listed