A study to compare triple therapy versus dual therapy in patients with asthma
- Conditions
- AsthmaMedDRA version: 19.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-001304-37-ES
- Lead Sponsor
- GlaxoSmithKline, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2250
AGE
1. 18 years of age or older at the time of signing the informed consent.
TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
2. Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes of Health at least one year prior to Visit 0.
3. Symptomatic: Subjects with inadequately controlled asthma despite ICS/LABA maintenance therapy at Visit 1.
4. Asthma Control: A documented non-routine healthcare visit due to acute asthma symptoms in the 1 year prior to Visit 1.
5. Current Asthma Maintenance Therapy: Subjects are eligible if they have required daily ICS/LABA for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total dose of ICS of >250 mcg/day fluticasone proprionate
Examples of acceptable doses of commonly prescribed ICS and LABA or ICS/LABA combination medication is provided in the Study Reference Manual (SRM). Dosing regimen should be restricted to the current local product labels.
6. Spirometry:
A best pre-bronchodilator morning FEV1 =30% and <80% of the predicted normal value at Visit 1. Predicted values will be based upon the European Respiratory Society Global Lung Function Initiative
7. Reversibility of Disease: airway reversibility defined as =12% and =200 mL increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1.
Note: If the subject does not meet the above reversibility criteria at Visit 1 then the reversibility assessment may be repeated once within 7 days of Visit 1 if either criteria a) or b) are met:
a) =9% increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1.
b) Documented evidence of a reversibility assessment within 1 year prior to Visit 1 which demonstrated a post-bronchodilator increase in FEV1 of =12% and =200 mL.
Should the subject successfully demonstrate airway reversibility at the second attempt then, provided that all other eligibility criteria assessed at Visit 1 are met, the subject may enter the 3-week runin period
8. Short-Acting ß2 Agonists: All subjects must be able to replace their current SABA inhaler with albuterol/salbutamol aerosol inhaler at Visit 1 as needed for the duration of the study. Subjects must be judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.
SEX
9. Male or Eligible Female, defined as having documentation of non-reproductive potential or reproductive potential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2025
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225
CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER FUNCTION AND QTc INTERVAL)
1. Pneumonia: Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
2. Asthma Exacerbation: Any asthma exacerbation requiring a change in maintenance asthma therapy in the 6 weeks prior to Visit 1.
Note: Subjects who experience an asthma exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator’s discretion, the subject’s condition is stable and they are considered appropriate for enrolment into this study of up to 12 months’ duration.
3. Chronic Obstructive Pulmonary Disease: Subjects with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease guidelines, including all of the following:
-History of exposure to risk factors;
AND
-A post-albuterol/salbutamol FEV1/Forced Vital Capacity ratio of <0.70 and a post-albuterol/salbutamol FEV1 of =70% of predicted normal values;
AND
-Onset of disease =40 years of age
4. Concurrent respiratory disorders: Subjects with current evidence of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.
5. Risk Factors for Pneumonia: immune suppression or other risk factors for pneumonia Patients at potentially high risk will only be included at the discretion of the Investigator.
6. Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine or hematological abnormalities that are uncontrolled. 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.
7. Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities. Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria
8. Clinically significant ECG abnormality: Evidence of a clinically significant abnormality in the 12-lead ECG performed during screening. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject’s medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following:
-Atrial Fibrillation with rapid ventricular rate >120 beats per minute (BPM);
-Sustained or nonsustained ventricular tachycardia;
-Second degree heart block Mobitz type II and third degree heart block (unless
pacemaker or defibrillator had been inserted);
-QTcF =500 msec in patients with
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Mean change from baseline in trough Forced Expiratory Volume in 1 second (FEV1) at Week 24;Timepoint(s) of evaluation of this end point: The primary analysis will be at 24 weeks. Data will be summarised at all timepoints where collected.;Main Objective: To evaluate the effects of FF/UMEC/VI on lung function compared with FF/VI after 24 weeks of treatment;<br> Secondary Objective: -To evaluate the efficacy of FF/UMEC/VI compared with FF/VI<br> -To evaluate the safety of FF/UMEC/VI compared with FF/VI<br> -To evaluate other efficacy assessments of FF/UMEC/VI compared with FF/VI<br>
- Secondary Outcome Measures
Name Time Method