A 12 week study to assess theefficacy and safety of switching from salmeterol/fluticasone to QVA149 in symptomatic COPDpatients.
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary Disease
- Registration Number
- CTRI/2015/08/006128
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 88
1. Written informed consent must be obtained before any assessment is performed.
2. Male and female >= 40 years
3. Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack
years is defined as 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years).
An ex-smoker is defined as a patient who has not smoked for >= 6 months at visit 1.
4. Confirmed diagnosis of COPD and post-bronchodilator FEV1 >= 30% and < 80% of the
predicted normal value and post-bronchodilator FEV1/FVC < 0.70 at visit 1
5. Treated with salmeterol/fluticasone 50/500 μg b.i.d. for at least 3 months prior to visit 1 (Salmeterol/fluticasone 50/500 μg b.i.d. treatment has been decided by the patientâ??s primary physician who has full discretion of the appropriateness of this treatment. This treatment decision has been taken outside the context of study and prior to the patientâ??s consideration for participating in the study)
6. Documented CAT score of >= 10 at Visit 1 and 2
1. Treatment with any LAMA in the 2 weeks prior to visit 1
2. Presence of any contraindication, warning, precaution, hypersensitivity in the approved
prescribing information for salmeterol/fluticasone
3. Prior or current diagnosis of asthma
4. History or current diagnosis of clinically significant ECG abnormalities including:
a)Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
b)History of familial long QT syndrome or known family history of Torsades de Pointes
5. Resting QTcF (Fridericia preferred) >= 450 msec (male) or >= 460 msec (female) during
screening (Visit 1 or 2)
6. Concomitant use of medication known to significantly prolong the QT interval unless it
can be permanently discontinued for the duration of the study
7. Clinically significant co-morbidity that could interfere with the assessment of the safety
and efficacy of the study medication
8. Paroxysmal (e.g. intermittent) atrial fibrillation; patients with persistent atrial fibrillation
as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate
control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement,digoxin or ablation therapy), for at least 6 months, may be considered for inclusion. In such patients, atrial fibrillation must be present at Visit 1 and 2, with a resting ventricular rate 100/min.
9. Contraindications or hypersensitivity to
a. Anticholinergic agents
b. Long and short-acting β2-agonists
c. Sympathomimetic amines
d. Lactose or any other excipient of the study medication or to drugs of similar
chemical classes
10. Any malignancy within the past 5 years except localized basal cell carcinoma of the skin
11. Narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck
obstruction or moderate to severe renal impairment or urinary retention. Asymptomatic
BPH patients are not excluded.
12. Not achieved acceptable spirometry results at visit 1 or 2 in accordance with the American
Thoracic Society (ATS) or European Respiratory Society (ERS) criteria for acceptability.
One retest may be performed for patients not meeting the acceptability criteria.
13. More than one COPD exacerbation requiring treatment with antibiotics and/or systemic
corticosteroids and/or hospitalization in the year prior to Visit 1
14. Patients who developed a COPD exacerbation of any severity within the 6 weeks before
the screening (Visit 1) or between screening (Visit 1) and start of treatment (Visit 2) will
not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after
the resolution of the COPD exacerbation
15. Respiratory tract infection within 4 weeks prior to Visit 1
16. Respiratory tract infection between Visit 1 and 2. Patients can be re-screened 4 weeks
after resolution of the infection
17. Requiring oxygen therapy prescribed for 12 hours per day
18. Onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years
19. Intermittent treatment with a H1-antagonist or intra-nasal corticosteroids for allergic
rhinitis (treatment with a stable dose/regimen is perm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate superiority of QVA149 110/50 µg o.d. compared to salmeterol/fluticasone 50/500 µg b.i.d. in trough pre-dose FEV1 at week 12.Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method COPD symptoms at week 12 as measured by the COPD Assessment Test (CAT)Timepoint: 12 weeks;FVC at week 12Timepoint: 12 weeks;Safety and tolerability during the 12 week treatment periodTimepoint: 12 weeks;The mean number of puffs per day of rescue medication use, and percentage of days without rescue medication use over the 12 week treatment periodTimepoint: 12 weeks;Total score of TDI at week 12Timepoint: 12 weeks