A Randomized, Parallel, Double-blind and Comparative Study that Evaluates Pulmonary Function and Other Measures of Asthma Control in Adults and Adolescents of At Least 12 Years of Age, with Persistent Asthma, Who Have Genotypes B16-Arg / Arg , B16- Gly / Gly or B-16 / Arg / Gly and that are treated with a Combination Product that contains Fluticasone Propionate / Salmeterol in the DISKUS System Administered in Dose of 100/50 mcg or with Salmeterol in a Dosage of 50 mcg in the DISKUS System Twice a Day.
- Conditions
- -J451 Nonallergic asthmaNonallergic asthmaJ451
- Registration Number
- PER-082-04
- Lead Sponsor
- GLAXOSMITHKLINE BIOLOGICALS,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Type of subject: A subject must be treatable in an outpatient modality.
• Age: The subject must be 12 years of age or older in Visit 1.
• Gender: Male or Female.
• Women are eligible to participate only if they are not currently pregnant and if they are not breastfeeding. There are no restrictions regarding birth control for the present study. Women subjects with potential to have a family will undergo a urine test to diagnose pregnancy at the beginning of the study (Visit 2) and at Visits 4, 6, 8, 10 and at the end of the study (Visit Premature Discontinuation). Any woman who becomes pregnant during the study will be withdrawn. Women subjects should not be enrolled if they plan to leave the pregnancy during the time of their participation in the study.
• Illness: Each subject should have a diagnosis of persistent asthma for at least 3 months before Visit 1, defined by the American Thoracic Society as follows: Asthma is a clinical syndrome characterized by a Increased reactivity of the tracheobronchial tree to a variety of stimuli The main symptoms of asthma are paroxysms of dyspnea, wheezing and cough, which can range from mild and almost undetectable to severe and non-remitting (asthmatic status) .The primary physiological manifestation of this Hyperreactivity is a variable obstruction of the airways.This can take the form of spontaneous changes in the severity of the obstruction, substantial improvements in the severity of the obstruction after using bronchodilators or corticosteroids, or a greater obstruction caused by drug its other stimuli [American Thoracic Society, 1987]
• FEVi Component: The subject has a better value of FEVj that is> 70% and <100% of the normal level predicted in Visit 1 after stopping medications for asthma, as detailed in the protocol. The predicted value for FEVi will be based on the predicted normal values for ages 8 years and above of the National Survey of Health and Nutrition Examination (NHANES III, National Health and Nutrition Examination Survey) [Hankinson, 1999].
• Reversibility Component: The subject has reversible airway disease, as demonstrated by an increase> 12% in FEVi and 200 mL with respect to the onset within 30 minutes after receiving treatments consisting of inhaling 2- 4 aerosolizations (160 pg-360 pg) of albuterol (with or without a spacer) or 1-2 albuterol sprays (2 sprays = 1 sprays) at Visit 1 or on a visit within the 7-day period immediately after of the Visit 1. If the subject does not reverse at least 12% during Visit 1, a second attempt for the reversal could be scheduled within a period of 7 days. If the second attempt to document reversibility was not successful, the subject could undergo a metacholine challenge test (MCT). If a PC20 <8 mg / mL is documented during an unscheduled visit prior to Visit 2, the subject is eligible. An MCT should not be done in any subject under 18 years of age. Challenge tests with methacholine should only be done in places with previous experience in carrying out the aforementioned test.
• Concurrent Anti-Asthma Therapy: Eligible subjects should have reported the use of p2 agonists in a demand (or scheduled) modality before Visit 1. Each subject should be qualified by the investigator as capable of stopping agonist therapy b2 short-acting at least 6 hours before clinic visits when FEV1 measurements are made.
• The subject agrees to have a venous puncture to take blood samples.
• The subject
• Potentially Lethal Asthma: The subject should not have potentially lethal asthma. Potentially lethal asthma is defined for the present protocol as a history of significant episodes of asthma requiring intubation, which have been associated with hypercapnia, respiratory arrest, hypoxic seizures, or episode (s) of syncope related to asthma.
• Asthma instability: The subject must not have been hospitalized due to asthma in the 6 months prior to Visit 1.
• Respiratory disease: Current evidence of cystic fibrosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis or any other respiratory abnormality other than asthma, excludes a subject from participating in the study.
• Asthma Medications: The asthma medications listed below must not have been used before the Selection (visit 1) for the required interval indicated below; and should not be taken during the study.
• Any subject who has been treated with oral corticosteroids for 2 months or more must have discontinued their use for at least 6 months before Visit 1.
• The subject must not have had two courses of oral or parenteral corticosteroids for the treatment of asthma in the 6 months prior to Visit 1.
• Concurrent medications: The concurrent use of any of the following medications that may affect the course of asthma or that interact with sympathomimetic amines will not be allowed.
• Immunosuppressive medications: The use of immunosuppressive medications is not allowed at any time during the study.
• Other Medications: The medications listed below must not have been used before the Selection (Visit 1) during the required time interval indicated below; and should not be taken during the study.
• Respiratory Tract Infections: The subject has a respiratory infection that is suspected or diagnosed within the 4 weeks immediately preceding Visit 1 or during the period from Visit 1 to Visit 6. The subject may go through the hospital again. selection once. This new selection should not be before 4 weeks after the resolution of any suspected or diagnosed respiratory infection (whether or not it has received treatment)
• Use of Antibiotics: The subject has used an antibiotic (or some other medication) for the treatment of a high respiratory infection or suspected or diagnosed within a period of 4 weeks of Visit 1 or during the periods between visits 1 to Visit 6. The subject could go through the selection once again. The use of antibiotics for other infections or for acne is allowed.
• Other Conditions / Concurrent Diseases: Any condition or state of clinically significant and uncontrolled disease that, in the opinion of the investigator, could jeopardize the safety of the subject due to participation in the study or that could distort the interpretation of the results if the Condition / disease when exacerbated during the study excludes a subject from participating in it. The list of conditions / diseases that result in exclusion from the study if it is determined to be clinically significant includes, but is not limited to, the following: cardiac arrhythmias, congestive heart failure, coronary heart disease, Cushing or Addison´s disease, diabetes mellitus , dyspnea for any cause other than asthma, hematological, hepatic, neurological, thyroid disease, peptic ulcer or kidney disease, uncontrolled hypertension, immunological compromise, current malignancy, active or quiescent tuberculosis.
• Drug Allergy: The
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The area under the curve that describes the morning PEF in relation to the initial values [AUC (bl)] over the period of sixteen weeks of double-blind treatment.<br>Measure:Morning PEF in relation to the initial values<br>Timepoints:16 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Area under the curve (which describes the morning PEF and FEV1 over time) in relation to the initial values<br>Measure:PEF and the morning FEV1 over time<br>Timepoints:During treatment<br>;<br>Outcome name:Clinical evaluation of signs and symptoms<br>Measure:Changes with respect to the start in the percentage of days without symptoms<br>Timepoints:During treatment<br>;<br>Outcome name:The need to add Atrovent to the treatment is evaluated, based on the clinical response<br>Measure:Supplementary use of Atrovent<br>Timepoints:During treatment<br>;<br>Outcome name:It is determined with the AUC (bl) of the morning PEF during the last four weeks of open-label treatment with albuterol administered on demand against what was observed during the last four weeks of open-label treatment with ipratropion bromide administered on demand, in accordance with the genotype.<br>Measure:Pulmonary function<br>Timepoints:4 weeks<br>