A MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-PERIOD CROSSOVER STUDY WITH GSK 573719 AS MONOTHERAPY IN ADULT SUBJECTS WITH ASTHMA
- Registration Number
- PER-045-12
- Lead Sponsor
- GlaxoSmithKline,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 87
• 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)
• • 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method