None listed
Conditions
Interventions
THE STUDY WILL EVALUATE FIVE DOSES OFGSK573719 INHALATION POWDER (15.6 MCG, 31.25 MCG, 62.5 MCG, 125 MCG AND 250 MCG) ADMINISTERED ONCE-DAILY
AND TWO DOSES OF GSK573719 INHALATION POWDER (15.6 MCG, 31.25 MCG) ADMINISTERED TWICE-DAILY (ONCE IN THE MORNING AND ONCE IN THE EVENING) VIA THE NOVEL DRY POWDER INHALER (DPI), OVER TREATMENT PERIODS
29, 30 TO ≤
49, AND ≥
50 YEARS.
Sponsors
GlaxoSmithKline,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • 1. INFORMED CONSENT: SUBJECTS MUST GIVE THEIR SIGNED AND DATED WRITTEN INFORMED CONSENT TO PARTICIPATE. 2. TYPE OF SUBJECT: OUT-PATIENTS. HOWEVER A SUB-GROUP OF SUBJECTS FROM SELECTED SITES WILL REMAIN IN THE CLINIC OVERNIGHT AT THE END OF EACH TREATMENT PERIOD FOR SERIAL SAFETY, EFFICACY AND PK BLOOD AND URINE ASSESSMENTS OVER A 24 HOUR PERIOD. 3. AGE: 18 YEARS OF AGE OR OLDER AT VISIT 1. 4. DIAGNOSIS: DIAGNOSIS OF ASTHMA AS DEFINED BY THE NATIONAL INSTITUTES OF HEALTH [NIH, 2007] AT LEAST 6 MONTHS PRIOR TO VISIT 1. 5. GENDER: MALE OR ELIGIBLE FEMALE, ELIGIBLE BEING DEFINED AS OF NON-CHILDBEARING POTENTIAL OR CHILDBEARING POTENTIAL USING AN ACCEPTABLE METHOD OF BIRTH CONTROL CONSISTENTLY AND CORRECTLY, AS DEFINED BY THE FOLLOWING: • MALE PARTNER WHO IS STERILE PRIOR TO THE FEMALE SUBJECT´S ENTRY INTO THE STUDY AND IS THE SOLE SEXUAL PARTNER FOR THAT FEMALE SUBJECT • IMPLANTS OF LEVONORGESTREL OR ETONOGESTREL • INJECTABLE PROGESTOGEN • ORAL CONTRACEPTIVE (EITHER COMBINED OR PROGESTOGEN ALONE) • ESTROGENIC VAGINAL RING • PERCUTANEOUS CONTRACEPTIVE PATCHES • ANY INTRAUTERINE DEVICE (IUD) WITH A DOCUMENTED FAILURE RATE OF LESS THAN 1 % PER YEAR. • MALE CONDOM COMBINED WITH A VAGINAL SPERMICIDE (FOAM, GEL, FILM, CREAM, OR SUPPOSITORY)
Exclusion criteria
Exclusion criteria: • • 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 WITHIN THE LAST 5 YEARS. • ASTHMA EXACERBATION: A SUBJECT MUST NOT HAVE A HISTORY OF ASEVERE ASTHMA EXACERBATION WITHIN 4 WEEKS PRIOR TO VISIT 1. ASEVERE ASTHMA EXACERBATION IS DEFINED AS DETERIORATION OF ASTHMA REQUIRING THE USE OF SYSTEMIC CORTICOSTEROIDS (ORAL, OR INJECTION) FOR AT LEAST 3 DAYS OR AN INPATIENT HOSPITALIZATION OR EMERGENCY DEPARTAMENT VISIT DUE TO ASTHMA THAT REQUIRED SYSTEMIC CORTICOSTEROIDS. • RESPIRATORY INFECTION EXPECTED TO AFFECT THE SUBJECT´S ABILITY TO PARTICIPATE IN THE STUDY: WITHIN 4 WEEKS PRIOR TO VISIT 1 A SUBJECT HAS HAD A CULTURE DOCUMENTED OR SUSPECTED BACTERIAL OR VIRAL INFECTION OF THE UPPER OR LOWER RESPIRATORY TRACT, SINUS OR MIDDLE EAR THAT IS NOT RESOLVED AND HAS LED TO A CHANGE IN ASTHMA MANAGEMENT OR, IN THE OPINION OF THE INVESTIGATOR, IS EXPECTED TO AFFECT THE SUBJECT´S ASTHMA STATUS OR THE SUBJECT´S ABILITY TO PARTICIPATE IN THE STUDY.
Countries
Bulgaria, Germany, Mexico, Peru, Poland, United States
Contacts
Public ContactJuan Vargas
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed