None listed
Conditions
Interventions
SUBJECTS WHO MEET THE ELIGIBILITY CRITERIA AT SCREENING WILL COMPLETE A 7- TO 10-DAY RUN-IN PERIOD FOLLOWED BY A 24-WEEK TREATMENT PERIOD. THERE WILL BE A TOTAL OF 9 CLINIC VISITS. A FOLLOW-UP PHONE C
ON DAY 169. SECONDARY ENDPOINTS INCLUDE WEIGHTED MEAN O-6 HOUR FEV₁
OBTAINED AFTER THE MORNING DOSE AT WEEK 24 AND CHANGE FROM BASELINE IN MEAN SOBDA SCORE DURING WEEK 24. SAFETY WILL BE ASSESSED BY ADVERSE EVENTS, COPD EXACERBATIONS, 12-1EAD ECGS, VITAL SIGNS, AND CL
Sponsors
GlaxoSmithKline,
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. TYPE OF SUBJECT: OUTPATIENT. 2. INFORMED CONSENT: A SIGNED AND DATED WRITTEN INFORMED CONSENT PRIOR TO STUDY PARTICIPATION. 3. AGE: SUBJECTS 40 YEARS OF AGE OR OLDER AT VISIT 1. 4. GENDER: MALE OR FEMALE SUBJECTS. A FEMALE IS ELIGIBLE TO ENTER AND PARTICIPATE IN THE. STUDY IF SHE IS OF: . NON-CHIID BEARING POTENTIAL (I.E. PHYSIOLOGICALLY INCAPABLE OF BECOMING PREGNANT, INCLUDING ANY FEMALE WHO IS POST-MENOPAUSAL OR SURGICALLY STERILE). SURGICALLY STERILE FEMALES ARE DEFINED AS THOSE WITH A DOCUMENTED HYSTERECTOMY ANDLOR BILATERAL OOPHORECTOMY OR TUBALLIGATION. POST-MENOPAUSAL FEMALES ARE DEFINED AS BEING AMENORRHOEIC FOR GREATER THAN 1 YEAR WITH AN APPROPRIATE CLINICAL PROFIJE, E.G. AGE APPROPRIATE > 45 YEARS, IN THE ABSENCE OF HORMONE REPLACEMENT THERAPY. HOWEVER IN QUESTIONABLE CASES, POST-MENOPAUSE STATUS MAY BE CONFIRMED BY ANALYSIS OF A BROAD SAMPLE WITH FSH> 40MIU/ML AND ESTRADIOL < 40PG/ML «140 PMOL/L) AS CONFIRRNATORY. OR . CHILD BEARING POTENTIAL, HAS A NEGATIVE PREGNANCY TEST AT SCREENING, AND AGREES TO ONE OF THE FOLLOWING ACCEPTABLE CONTRACEPTIVE METHODS USED CONSISTENTLY AND CORRECTLY (IE. IN ACCORDANCE WITH THE APPROVED PRODUCT LABEL AND THE INSTRUCTIONS OF THE PHYSICIAN FOR THE DURATION OF THE STUDY - SCREENING TO FOLLOW-UP CONTACT): • ABSTINENCE • ORAL CONTRACEPTIVE, EITHER COMBINED OR PROGESTOGEN ALONE
Exclusion criteria
Exclusion criteria: 1. PREGNANCY: WOMEN WHO ARE PREGNANT OR LACTATING OR ARE PLANNING ON BECOMING PREGNANT DURING THE STUDY 2. ASTHMA: A CURRENT DIAGNOSIS OF ASTHMA 3. OTHER RESPIRATORY DISORDERS: KNOWN RESPIRATORY DISORDERS OTHER THAN COPD INCLUDING BUT NOT LIMITED TO Α-1 ANTITRYPSIN DEFICIENCY, ACTIVE TUBERCULOSIS, BRONCHIECTASIS, SARCOIDOSIS, LUNG FIBROSIS, PULMONARY HYPERTENSIAN, AND INTERSTITIAL LUNG DISEASE. ALLERGIC RHINITIS IS NOT EXCLUSIANARY. 4. OTHER DISEASES/ABNORMALITIES: SUBJECTS WITH HISTARICAL OR CURRENT EVIDENCE OF CLINICALLY SIGNIFICANT CARDIOVASCULAR, NEUROLOGICAL, PSYCHIATRIC, RENAL, HEPATIC, IRNMUNOLOGICAL, ENDOCRINE (INCLUDING UNCONTROLLED DIABETES AR THYROID DISEASE) OR HEMATOLOGICAL ABNORMALITIES THAT ARE UNCONTRALLED AND/OR A PREVIOUS HISTORY OF CANCER IN REMISSION FOR <5 YEARS PRIOR TO VISIT 1 (LOCALIZED CARCINOMA OF THE SKIN THAT HAS BEEN RESECTED FOR CURE IS NOT EXCLUSIONARY). SIGNIFICANT IS DEFINED AS ANY DISEASE THAT, IN THE OPINION OF THE INVESTIGATOR, WOULD PUT THE SAFETY OF THE SUBJECT AT RISK THROUGH PARTICIPATION, OR WHICH WOULD AFFECT THE EFFICACY OR SAFETY ANALYSIS IF THE DISEASE/CONDITION EXACERBATED DURING THE STUDY. 5. CHEST X-RAY: A CHEST X-RAY OR COMPUTED TOMOGRAPHY (CT) SCAN THAT REVEALS EVIDENCE OF CLINICALLY SIGNIFICANT ABNORMALITIES NOT BELIEVED TO BE DUE TO THE PRESENCE OF COPD.
Countries
Romania, Ukraine
Contacts
Public ContactSarita Mattos
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed