Clinical Research Study to compare Umeclidinium/Vilanterol, Umeclidimium, and Salmeterol in subjects with chronic obstructive pulmonary disease (COPD).

Phase 1

• Conditions: Chronic obstructive pulmonary disease (COPD); MedDRA version: 19.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-002513-22-FR
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-27
• Study Completion: 2018-06-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2425

Inclusion Criteria

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

AGE
1. 40 years or older at date of signing informed consent at Screening Visit 1.
TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
2. Outpatient with a diagnosis of COPD.
3. FEV1: Persistent airflow limitations as indicated by: A pre and postalbuterol/ salbutamol FEV1/FVC ratio of <0.70 and a post-albuterol/salbutamol FEV1 of =30% to =80% predicted normal values at Screening Visit 1.
4. CAT score: A CAT score of =10 at Screening Visit 1.

Smoking History
5. Current or former cigarette smokers with a history of cigarette smoking of = 10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g. 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years both equal 10 pack-years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack-year history.

SEX
6. Male and female subjects are eligible to participate in the study
A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies:
a. Non-reproductive potential defined as:
Pre-menopausal females with one of the following:
• Documented tubal ligation
• Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
• Hysterectomy
• Documented Bilateral Oophorectomy
Postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause must be tested. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study.
Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
b. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until [at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer] after the last dose of study medication and completion of the follow-up visit.
The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.

INFORMED CONSENT
7. Capable of giving signed informed consent prior to study participation, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER FUNCTION
1. Asthma
2. Alpha-antitrypsin deficiency
3. Other respiratory disorder
4. Unstable liver disease
5. Unstable or life threatening cardiac disease
6. 12 Lead ECG:
7. Antimuscarinic effects
8. Other disease abnormalities
9. Hospitalization
10. Inhaled corticosteroids (ICS)
11. Exacerbation
12. Other respiratory tract infections
13. Lung Resection
14. Oxygen
(For detailed list, please refer to pages 27-29 of the study protocol)

CONCOMITANT MEDICATIONS
1. Medications prior to Screening: Use of the following medications according to the following defined time intervals prior to Screening (Visit 1) (Please refer to table listed on page 29 of study protocol)
2. Medication prior to spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
3. Maintenance use of short-acting bronchodilators: Regular use (prescribed for daily/ regular use, not for as-needed use) of short-acting bronchodilators (e.g. albuterol/salbutamol).

RELEVANT HABITS
1. Drug or alcohol abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Screening Visit 1 that in the opinion of the investigator would prevent the subject from completing the study procedures.

CONTRAINDICATIONS
1. Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, sympathomimetic, lactose/milk protein or magnesium stearate.

DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA
1. Pulmonary Rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
2. Affiliation with investigator sites: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study
3. Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete questionnaires on the electronic diary.

Subjects who fail to meet inclusion and exclusion criteria at the Screening Visit 1 will be considered screen failures and cannot be re-screened.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified