A randomised study, comparing FF/UMEC/VI single inhaler triple therapy, versus multiple inhaler therapy(budesonide/formoterol plus tiotropium) in participants with chronic obstructive pulmonary disease

Phase 1

• Conditions: Chronic obstructive pulmonary disease (COPD); MedDRA version: 20.0 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: EUCTR2017-001149-28-CZ
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-18
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 732

Inclusion Criteria

1. Informed consent: capable of giving signed informed consent prior to study start which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

2. Type of participant: Outpatient.

3. Age: Participants 40 years of age or older at Screening (Visit 1).

4. Gender: Male or female participants.
Female participants:
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP)
OR
A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 of the protocol during the treatment period and until the safety follow-up contact after the last dose of study treatment.

5. COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004].

6. Smoking History: Current or former cigarette smokers with a history of cigarette smoking of =10 pack-years at Screening (Visit 1) [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)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
Note: Pipe and/or cigar use cannot be used to calculate pack-year history.

7. Severity of COPD symptoms: A score of =10 on the COPD Assessment Test (CAT) at Screening (Visit 1).

8. Severity of Disease:
Participants must demonstrate at Screening: a post-bronchodilator FEV1<50 % predicted normal
OR a post-bronchodilator FEV1<80 % predicted normal and a documented history of =2 moderate exacerbations or one severe (hospitalized) exacerbation in the previous 12 months.
Participants must also have a measured post albuterol/salbutamol FEV1/forced vital capacity (FVC) ratio of <0.70 at screening.
Note: Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations [Quanjer, 2012].
Note: A documented history of a COPD exacerbation (e.g., medical record verification) is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or
hospitalization (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnoea, sputum volume, or sputum purulence (colour). Participant verbal reports are not acceptable.

9. Existing COPD maintenance treatment: participant must have been receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening.
Note: Participants taking only as-needed COPD medications are not eligible.

Are the trial subjects under 18? no

Exclusion Criteria

1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.

2. Asthma: Participants with a current diagnosis of asthma. (Participants with a prior history of asthma are eligible if they have a current diagnosis of COPD).

3. a1-antitrypsin deficiency: Participants with a1-antitrypsin deficiency as the underlying cause of COPD.

4. Other respiratory disorders: Participants with active tuberculosis, lung cancer, and clinically significant: bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease or other active pulmonary diseases.

5. Lung resection: Participants who have undergone lung volume reduction surgery within the 12 months prior to Screening.

6. Risk Factors for Pneumonia: immune suppression (e.g. advanced human immunodeficiency virus [HIV] with high viral load and low CD4 count, lupus on immunosuppressants) that in the opinion of the investigator would increase risk of pneumonia or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson’s Disease, Myasthenia Gravis).
Participants at potentially high risk for pneumonia (e.g. very low body mass index [BMI], severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator.

7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable).

8. Respiratory tract infection that has not resolved at least 7 days prior to Screening.

9. Abnormal Chest x-ray: Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on chest X-ray (e.g. significant cardiomegaly, pleural effusion or scarring).
All participants will have a chest X-ray at Screening Visit 1 (or historical radiograph or computerized tomography [CT] scan obtained within 3 months prior to screening).
Note: Participants who have experienced pneumonia and/or moderate or severe COPD exacerbations within 3 months of screening must provide a post pneumonia/exacerbation chest X-ray or have a chest X-ray conducted at Screening.
For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (BfS).

10. Other diseases/abnormalities: Participants with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at

Study & Design

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