None listed
Conditions
Interventions
SUBJECTS WILL BE RANDOMIZED TO TREATMENT AFTER A 4-10 DAY RUN-IN PERIOD. PRIOR TO RUN-IN, SUBJECTS WILL DISCONTINUE USE OF PREVIOUS COPD MEDICATIONS EXCEPT FOR SHORT-ACTING BRONCHODILATORS AND THEOPHY
Sponsors
GlaxoSmithKline,
Eligibility
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. TYPE OF SUBJECT: OUTPATIENT. 2. INFORMED CONSENT: SUBJECTS MUST GIVE THEIR SIGNED AND DATED WRITTEN INFORMED CONSENT TO PARTICIPATE. 3. GENDER: MALE OR FEMALE. FEMALE SUBJECTS MUST BE POST-MENOPAUSAL OR USING A HIGHLY EFFECTIVE METHOD FOR AVOIDANCE OF PREGNANCY. THE DECISION TO INCLUDE OR EXCLUDE WOMEN OF CHILDBEARING POTENTIAL MAY BE MADE AT THE DISCRETION OF THE INVESTIGATOR IN ACCORDANCE WITH LOCAL PRACTICE IN RELATION TO ADEQUATE CONTRACEPTION. 4. AGE: ≥ 40 AND ≤ 80 YEARS OF AGE AT SCREENING (VISIT 1). 5. TOBACCO USE: SUBJECTS WITH A CURRENT OR PRIOR HISTORY OF ≥ 10 PACK-YEARS OF CIGARETTE SMOKING AT SCREENING (VISIT 1). PREVIOUS SMOKERS ARE DEFINED AS THOSE WHO HAVE STOPPED SMOKING FOR AT LEAST 6 MONTHS PRIOR TO VISIT 1. 6. AIRFLOW OBSTRUCTION: • SUBJECTS WITH A MEASURED POST-ALBUTEROL/SALBUTAMOL FEV1/FVC RATIO OF ≤ 0.70 AT SCREENING (VISIT 1). • SUBJECTS WITH A MEASURED POST-ALBUTEROL/SALBUTAMOL FEV1 ≥ 50 AND ≤ 70% OF PREDICTED NORMAL VALUES CALCULATED USING NHANES III REFERENCE EQUATIONS [HANKINSON, 1999; HANKINSON, 2010] AT SCREENING (VISIT 1). POST-BRONCHODILATOR SPIROMETRY WILI BE PERFORMED APPROXIMATELY 15 MINUTES AFTER THE SUBJECT HAS SELF-ADMINISTERED 4 INHALATIONS (I.E., TOTAL 400 MCG) OF ALBUTEROL/SALBUTAMOL VIA AN MOL WITH A VALVED-HOLDING CHAMBER. THE FEV1/FVC RATIO AND FEV1 PERCENT PREDICTED VALUES WILL BE CALCULATED.
Exclusion criteria
Exclusion criteria: 1. PREGNANCY: WOMEN WHO ARE PREGNANT OR LACTATING. 2. ASTHMA: SUBJECTS WITH A CURRENT DIAGNOSIS OF ASTHMA. (SUBJECTS WITH A PRIOR HISTORY OF ASTHMA ARE ELIGIBLE IF THEY ALSO HAVE A CURRENT DIAGNOSIS OF COPD). 3. Α1-ANTITRYPSIN DEFICIENCY: SUBJECTS WITH KNOWN Α-1 ANTITRYPSIN DEFICIENCY AS THE UNDERLYING CAUSE OF COPD. 4. OTHER RESPIRATORY DISORDERS: SUBJECTS WITH ACTIVE TUBERCULOSIS, LUNG CANCER, BRONCHIECTASIS, SARCOIDOSIS, PULMONARY FIBROSIS, PULMONARY HYPERTENSION, INTERSTITIAL LUNG DISEASES OR OTHER ACTIVE PULMONARY DISEASES. 5. LUNG RESECTION OR TRANSPLANTATION: SUBJECTS WITH LUNG VOLUME REDUCTION SURGERY WITHIN THE 12 MONTHS PRIOR TO SCREENING OR HAVING HAD A LUNG TRANSPLANT. 6. A MODERATE/SEVERE COPD EXACERBATION THAT HAS NOT RESOLVED AT LEAST 14 DAYS PRIOR TO VISIT 1 AND AT LEAST 30 DAYS FOLLOWING THE LAST DOSE OF ORAL CORTICOSTEROIDS (IF APPLICABLE ). 7. CURRENT SEVERE HEART FAILURE (NEW YORK HEART ASSOCIATION CLASS IV). SUBJECTS WILL ALSO BE EXCLUDED IF THEY HAVE A KNOWN EJECTION FRACTION OF <30% OR IF THEY HAVE AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 8. OTHER DISEASES/ABNORMALITIES: ANY LIFE-THREATENING CONDITION WITH LIFE EXPECTANCY <3 YEARS, OTHER THAN VASCULAR DISEASE OR COPD, THAT MIGHT PREVENT THE SUBJECT FROM COMPLETING THE STUDY.
Countries
Argentina, Australia, Canada, Chile, Estonia, Germany, Italy, Mexico, Netherlands, Philippines, South Africa, Sweden, United Kindgdom, United States
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed