None listed
Conditions
Interventions
Group 1 Type of group
GW685698X 200 mcg once a day during the morning through a novel inhaler for dry powder and placebo twice a day through DISKUS / ACCUHALER (one inhalation during the morning and one inhalation during the night).
Group name:Group 6 Type of group
Placebo once a day during the morning through the new inhaler for dry powder and placebo twice per day through DISKUS / ACCUHALER (one inhalation during the morning and one inhalation during the night)
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Type of subject: ambulatory • Age: 12 years or more at Visit 1. For centers in the following countries, the subjects recruited will be 18 years of age: Bulgaria, Czech Republic, Germany, Greece, Lithuania, New Zealand, Russian Federation, Turkey and any other country in which local regulations or the regulatory status of study medication only allow enrollment of adults. • Sex: Men or eligible women. To be eligible to enter the study, women of childbearing age must commit to consistently and correctly using an acceptable method of contraception. • Diagnosis of asthma: Asthma as defined by the [National Institutes of Health (NIH) 2002]. • Severity of the disease: The best FEVi of 40% -85% of the normal predicted value during the Visit 1. The predicted values ​​according to the NHANES III (Third National Health and Nutrition Examination Survey) will be used for the subjects of 12 years of age and adjustments will be made to the predicted values ​​in African-American subjects. [Hankinson, 1999]. • Reversibility of the disease: Having demonstrated a reversibility of 12% and 200 ml in the FEVi within 30 minutes after 4 inhalations of albuterol / salbutamol inhalation aerosol (the inhalation chambers are allowed only for the evaluation of the reversibility, in case of be necessary) or a nebulized solution of albuterol / salbutamol at the Screening Visit. If a subject fails to demonstrate an increase in FEVi 12% and 200 ml, then that subject is not eligible for the study and will not be allowed to be selected again. • Current anti-asthma treatment: Subjects must have been maintained at a stable dose of inhaled corticosteroids during the four weeks prior to Visit 1 • Short-acting Beta2 agonists: All subjects should be able to replace their short-acting beta2 agonists with albuterol / salbutamol inhalatory spray at Visit 1 for use as needed throughout the study. The use of inhaled cameras with inhaled MDI or albuterol / salbutamol will not be allowed during the study, except for its use during the reversibility test in Visit 1. Subjects should be able to suspend all inhaled short-acting beta-sympathomimetic bronchodilators during at least 6 hours before all study visits. • Informed Consent: All subjects must be able and willing to give written informed consent to participate in the study. • Compliance: Subjects must be able to comply with the filling of the Journal, which must be completed daily (includes a paper diary for diseases) • French Subjects: In France, a subject will be eligible for inclusion in this study only if he or she is a member of or is a beneficiary of a social security category.
Exclusion criteria
Exclusion criteria: • History of asthma that implies a threat to life: Defined for this protocol as an episode of asthma that required intubation and / or has been associated with hypercapnia, respiratory arrest or hypoxic convulsions. • Respiratory infection: Bacterial or viral infection of the upper or lower respiratory tract, paranasal sinuses or middle ear, documented by culture or suspected, that has not been resolved within 4 weeks of Visit 1. In addition, the subject must be excluded if said infection occurs between Visits 1 and 3. • Exacerbation of asthma: Any exacerbation of asthma requiring oral corticosteroids within 3 months of Visit 1. Subjects must not have had any hospitalization for asthma within 6 months prior to Visit 1. • Concurrent diseases / abnormalities: Background or current evidence of clinically significant, uncontrolled disease, including, but not limited to: cardiovascular disease, liver disease, kidney disease, hematologic disease, neurological disease, or lung disease (including, but not limited to chronic bronchitis) , emphysema, bronchiectasis in need of treatment, cystic fibrosis, bronchopulmonary dysplasia and chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk in the event that the participant participated, or that could affect efficacy or safety analyzes if the illness / condition were exacerbated during the study. • Oropharyngeal examination: A subject will not be eligible for the pre-inclusion period if he has visual clinical evidence of oral candidiasis at Visit 1. • Drugs in research: A subject must not have participated in a study or used any research drug within 30 days prior to Visit 1. • Drug allergy: Any adverse reaction, including immediate or delayed hypersensitivity to any beta2 agonist, sympathomimetic drug or any intranasal, inhalational or systemic corticosteroid therapy. Known or suspected sensitivity to the components of the novel dry powder inhaler or DISKUS / ACCUHALER (ie, lactose or magnesium stearate). • Allergy to milk proteins: History of severe allergy to milk proteins. • Immunosuppressant medications: A subject should not be using, or require the use of, immunosuppressive medications during the study. • Attendance: A subject will not be eligible if he / she or his / her parent or legal representative has any weakness, disability or living in any geographic location that could (in the opinion of the Investigator) impede the. compliance with any of the aspects of this study protocol or scheduled visits to the study center and if it does not comply with the medication or study procedures (eg complete the diary every day). A neurological or psychiatric disease or a history of drug or alcohol abuse that, in the opinion of the investigator, may interfere with the subject´s appropriate compliance with the protocol´s requirements excludes it from participation in the study. • Use of tobacco: Current smoker or smoking history of 10 packs a year or more (eg 20 cigarettes / day for 10 years). The subject may not have used products that contain tobacco within the last year (ie, cigarettes, cigars or pipe tobacco). • Affiliation with the Investigator Center: A subject will not be eligible for this study if it is a direct family member of the participating Investigator, a sub-Investigator, the study coordinator or an employee of the participating Inve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Mean change, from the baseline assessment to the end of the 8-week treatment period, at the minimum FEV1 (pre-dose AM and salvage bronchodilator). Measure:Change in the minimum FEV1 Timepoints:8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Mean change from the baseline visit in the PEF AM and the PEF PM (prior to the dose and the rescue bronchodilator) daily minimum averaged over the treatment period of 8 weeks. Measure:change from the baseline visit in the PEF AM Timepoints:8 weeks. ; Outcome name:Average change from the baseline visit in the percentage of 24-hour periods no symptoms and 24-hour periods without rescue during the treatment period 8 weeks Measure:change from the baseline visit in the percentage of 24-hour periods no symptoms Timepoints:8 weeks ; Outcome name:The number of discontinuations due to lack of efficacy during the 8-week treatment period. Measure:number of discontinuations due to lack of efficacy Timepoints:8 weeks ; Outcome name:Incidence of adverse events throughout the 8-week treatment period Measure:Incidence of adverse events throughout the 8-week treatment period Timepoints:8 weeks | — |
Countries
Bulgaria, Czech Republic, Estonia, France, Germany, Netherlands, Poland
Contacts
Public ContactElisa Guadalupe Velarde
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed