None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with GW685698X (in DISKUS / ACCUHALER devices), in a dose of 200 mcg in one inhalation, BID, in the mornings and in the nights, for 56 days. In case of asthma crisis they will use albuterol / salbutamol in inhalers provided by the research team.
Group name:GROUP 6 Type of group
This group will be treated with GW685698X Placebo (in DISKUS / ACCUHALER devices), in one inhalation, BID, in the mornings and at night, for 56 days. In case of asthma crisis they will use albuterol / salbutamol in inhalers.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Type of Patient: Ambulatory. 2. Age: 12 years of age or older at visit 1 (or ≥ 18 years of age or older if local regulations or the regulatory condition for study medication allows only adult patients to enroll). 3. Gender: Men or eligible women. Women are eligible to participate only if they are not gestating or breastfeeding. In order to be eligible to enter the study, women with the potential to have a family must commit to consistently and correctly using an acceptable method of birth control. 4. Diagnosis of Asthma. 5. Severity of the Disease: A better morning value (AM) of the forced expiratory volume in the first second (FEV1) between 50% and 80% of the value predicted during Visit 1. 6. Reversibility of the Disease: Reversibility ≥ 12% and 200 mL of FEV1 demonstrated within 30 minutes after administering 200 to 400 mcg of albuterol / salbutamol aerosol for inhalation in Visit 1. 7. Concurrent Therapy Against Asthma: Patients should be using an inhaled corticosteroid daily at least 3 months before Visit 1; and should be kept in a stable dose for 4 weeks before Visit 1. 8. Short Action Beta 2 Agonists: All patients should be able to replace the short-acting beta 2 agonists with albuterol / salbutamol spray for inhalation at Visit 1. 9. Informed Consent: All patients must be able and willing to give written informed consent to participate in the study. 10. Compliance: Patients must be able to meet all the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. History of Potentially Lethal Asthma. 2. Asthma Medications: The following medications for asthma should not have been used prior to visit 1, at the intervals indicated below; and should not be taken during the study: A) Within the previous 24 hours: short-acting oral beta 2 agonists. B) Within the previous 2 weeks: a) Combination therapy containing beta 2 agonists and inhaled corticosteroids for asthma. b) Slow release bronchodilators. c) Anticholinergics. d) Long-acting beta 2 agonists. e) Ketotifen. f) Nedocromil sodium. g) Sodium cromoglycate. h) Long-acting oral beta-2 agonists. C) Within the previous 4 weeks: Anti-leukotrienes. D) Within the previous 12 weeks: a) Systemic corticosteroids. b) Anti-IgE. 3. Other Medications: Potent known inhibitors of the CYP3A4 system should not have been used. 4. Respiratory Infections: History of a respiratory tract infection within 4 weeks prior to Visit 1. 5. Exacerbations of Asthma: History of an asthma exacerbation within the previous 4 weeks, any exacerbation of asthma requiring corticosteroids administered orally within 3 months prior to Visit 1, or any hospitalization due to an exacerbation of asthma within 6 months prior to Visit 1. 6. Research Medication: A patient must not have used any investigational drug within 30 days prior to Visit 1 or within ten half lives (t 1/2) of the drug. 7. Abnormal Result in the Ultrasound Study of the Gallbladder: A patient should not have an abnormal result in the ultrasound study of the gallbladder in Visit 1 or a history of current gallbladder disease. 8. Diseases / Concurrent Abnormalities: Historical or current evidence of clinically significant and uncontrolled disease. 9. Oropharyngeal Examination: A patient will not be eligible for the introductory period if he / she had evidence of oropharyngeal candidiasis at Visit 1. 10. Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta 2 agonist, sympathomimetic drug, or any therapy with intranasal, inhalational or systemic corticosteroids. 11. Allergy to Milk Proteins: History of severe allergy to milk proteins. 12. Immunosuppressive medications: A patient should not be using or require the use of immunosuppressive medications during the study. 13. Attendance: A patient will not be eligible if he / she or his / her father or mother or legal representative has any illness, disability or if he / she lives in a geographic location that generates the probability of affecting compliance with any aspect of the protocol of the present study or with the scheduled visits. It also excludes from the participation in the study the presence of any neurological or psychiatric disease or a history of drug or alcohol abuse that could interfere with the appropriate compliance with the protocol requirements by the patient. 14. Use of tobacco: A patient must not have used tobacco products within the previous year and must not have had a historical use> 10 packs per year. 15. Affinity with the Researcher´s Headquarters: A patient will not be eligible if he or she is an immediate family member of the researcher, assistant researcher or coordinator of the participating study, or if he or she is an employee of the participating researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The minimum values (valley) of FEV1 will be measured prior to the dose, prior to the inhalation of albuterol / salbutamol in aerosol between 6 AM and 11 AM and in the visits to the clinic in electronic form, from the curves of flow-volume generated by spirometry. The maximum value of three technically acceptable measurements will be recorded. Measure:Average variation with respect to the start in the Week 8 in the minimum values (valley) of the forced expiratory volume in the first second (FEV1). Timepoints:Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Adverse Events: Each adverse event that occurs during the study must be documented in the Case Report Format. 2) Urinary cortisol: 24-hour urine collection for the measurement of cortisol and creatinine levels. 3) Laboratory analysis: Hematology and serum chemistry panels, urinalysis. 4) Ultrasound of the Biliary Vesicle: Which should be interpreted by a qualified radiologist. 5) Oropharyngeal examination: Visual evidence of candidiasis will be sought. 6) Vital signs: One single pulse and blood pressure evaluation per visit. The patient should be seated for at least 5 minutes before and will be evaluated in a sitting position. 7) Withdrawals from the study: If the patient presents: a) FEV1 below the limit of stability. b) During the 7 days immediately prior to the visit: More than 3 days with maximum expiratory flow (PEF) below the Limit of stability OR More than 2 days in which have been used> 12 inhalations / day of albuterol / salbutamol in spray. c) Clinical exacerbation of asthma, defined as an exacerbation of asthma that requires any treatment apart from the study medication. Measure:Safety of treatment: 1) Incidence of adverse events. 2) Determination of urinary excretion of cortisol for 24 hours before and after the treatment period. 3) Laboratory analysis before, during and after the treatment period. 4) Ultrasound study of the gallbladder before and after the treatment period. 5) Oropharyngeal examination. 6) Evaluation of vital signs. 7) Withdrawals from the study due to worsening asthma during the treatment period. Timepoints:1) Adverse events, oropharyngeal examination, vital signs: Day 0 and weeks 1, 2, 4, 6 and 8. 2) Urinary cortisol, laboratory analysis, ultrasound of the gallbladder: Day 0 and week 8. 3) Withdrawals from the study: When the event is presented. ; Outcome name:1) Pharmacokinetics: Two blood samples of 4 ml each will be taken to each patient. To determine characteristics of | — |
Countries
Australia, Bulgaria, Canada, Chile, Costa Rica, Croatia, Germany, Israel, Mexico, New Zealand, Philippines, Russian Federation, South Africa, Thailand, Ukraine, United States
Outcome results
None listed