DB2114930: A RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UMECLIDINIUM/VILANTEROL COMPARED WITH FLUTICASONE PROPIONATE/SALMETEROL OVER 12 WEEKS IN SUBJECTS WITH COPD

Not Applicable

• Conditions: -J44 Other chronic obstructive pulmonary disease; Other chronic obstructive pulmonary disease; J44

• Registration Number: PER-125-12
• Lead Sponsor: GlaxoSmithKline,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 14

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-CHILD 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 AND/OR BILATERAL OOPHORECTOMY OR TUBAL LIGATION. POST-MENOPAUSAL FEMALES ARE DEFINED AS BEING AMENORRHOEIC FOR GREATER THAN 1 YEAR WITH AN APPROPRIATE CLINICAL PROFILE, E.G. AGE APPROPRIATE, > 45 YEARS, IN THE ABSENCE OF HORMONE REPLACEMENT THERAPY.
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 (I.E. 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
• INJECTABLE PROGESTOGEN
• IMPLANTS OF LEVONORGESTREL

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 Α-1 ANTITRYPSIN DEFICIENCY, ACTIVE LUNG INFECTIONS (SUCH AS TUBERCULOSIS), AND LUNG CANCER ARE ABSOLUTE EXCLUSIONARY CONDITIONS. A SUBJECT, WHO, IN THE OPINION OF THE INVESTIGATOR, HAS ANY OTHER SIGNIFICANT RESPIRATORY CONDITION IN ADDITION TO COPD SHOULD BE EXCLUDED. EXAMPLES MAY INCLUDE CLINICALLY SIGNIFICANT BRONCHIECTASIS, PULMONARY HYPERTENSION, SARCOIDOSIS, OR INTERSTITIAL LUNG DISEASE. INACTIVE TUBERCULOSIS IN MORE THAN ONE LOBE IS EXCLUSIONARY. ALLERGIC RHINITIS IS NOT EXCLUSIONARY.
4. OTHER DISEASES/ABNORMALITIES: SUBJECTS WITH HISTORICAL OR CURRENT EVIDENCE OF CLINICALLY SIGNIFICANT CARDIOVASCULAR, NEUROLOGICAL, PSYCHIATRIC, RENAL, HEPATIC, IMMUNOLOGICAL, ENDOCRINE (INCLUDING UNCONTROLLED DIABETES OR THYROID DISEASE) OR HEMATOLOGICAL ABNORMALITIES THAT ARE UNCONTROLLED 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified