STUDY DB2116961, A MULTICENTRE, RANDOMISED, BLINDED, DOUBLE-DUMMY, PARALLEL GROUP STUDY TO COMPARE UMEC/VI (UMECLIDINIUM/VILANTEROL) IN A FIXED DOSE COMBINATION WITH INDACATEROL PLUS TIOTROPIUM IN SYMPTOMATIC SUBJECTS WITH MODERATE TO VERY SEVERE COPD

Not Applicable

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

• Registration Number: PER-018-14
• Lead Sponsor: GlaxoSmithKline,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 57

Inclusion Criteria

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.
5. Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
7.Severity of Disease: A pre and post-albuterol/salbutamol FEV₁/FVC ratio of <0.70 and a pre and post-albuterol/salbutamol FEV₁ of ≤70% predicted normal value at Visit 1, calculated using NHANES III reference equations [Hankinson, 1999; Hankinson, 2010].
8. Dyspnoea: A score of ≥ 2 on the Modified Medical Research Council Dyspnoea Scale (mMRC) at Visit 1.
9.QTc Criteria:
QTc <450 msec or
QTc <480 msec for patients with bundle branch block
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

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.
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).
5.Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta₂-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician, contraindicates study participation or use of an inhaled anticholinergic or beta₂ agonist.
6.Hospitalisation: Hospitalisation for COPD or pneumonia within 12 weeks prior to Visit 1.

Study & Design

• Study Type: Interventional
• Study Design: Not specified