Comparison of Indacaterol and Tiotropium on Lung Function and Related Outcomes in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
- Registration Number
- EUCTR2008-007944-33-CZ
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3500
1.Male and female adults aged =40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
2.Patients diagnosed with COPD at age 40 and over
3.Co-operative outpatients with a diagnosis of COPD (severe as classified by the GOLD Guidelines, 2007 and including:
Smoking history of at least 10 pack years, both current and ex-smokers are eligible
Post-bronchodilator FEV1 <50% and =30% of the predicted normal value
Post-bronchodilator FEV1/FVC <70%
A documented history of at least 1 moderate or severe exacerbation in the previous 12 months (where exacerbation is defined as worsening of 2 or more of the following major symptoms for at least 2 consecutive days:
•dyspnea
•sputum volume
•sputum purulence
AND requiring treatment with systemic corticosteroids and/or antibiotic.
OR
worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days:
•sore throat
•colds (nasal discharge and/or nasal congestion)
•fever without other cause
•increased cough
•increased wheeze
AND requiring treatment with systemic corticosteroids and/or antibiotic.
COPD exacerbations are considered of moderate severity if treatment with systemic corticosteroids and/or antibiotic was required and severe if hospitalization was required also. An Emergency Room (ER) visit of longer than 24 hours will be considered a hospitalization.
(Post refers to 15 min after inhalation of 400 µg (4x100µg) of salbutamol, equivalent to 4 x 90 µg albuterol delivered at the mouthpiece, at Visit 2).
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 1841
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1604
1.Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
2.Patients requiring long-term oxygen therapy (>15 h a day) for chronic hypoxemia
3.Patients who have had a respiratory tract infection within 6 weeks prior to screening
4.Patients with concomitant pulmonary disease
5.Patients with a history of asthma
6.Patients with diabetes Type I or uncontrolled diabetes Type II
7.Any patient with lung cancer or a history of lung cancer
8.Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
9.Patients with a history of long QT syndrome or whose QTc interval (Fredricia’s) measured at screening is prolonged
10.Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
11.Patients unable to successfully use a dry powder inhaler device, or perform spirometry measurements
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To demonstrate that indacaterol 150 µg o.d, is non inferior to tiotropium 18 µg o.d. with regard to the rate of exacerbations during 52 weeks of treatment.;Primary end point(s): To demonstrate non-inferiority of 150 µg o.d. of indacaterol versus tiotropium 18 µg o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment. Trough is defined as the mean of FEV1 measurements at 23h 10 min and 23h 45 min post morning dose.;Timepoint(s) of evaluation of this end point: 12 weeks;Main Objective: To demonstrate non-inferiority of 150 µg o.d. of indacaterol versus tiotropium 18 µg o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment. Trough is defined as the mean of FEV1 measurements at 23h 10 min and 23h 45 min post morning dose.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To demonstrate that indacaterol 150 µg o.d. is non inferior to tiotropium 18 µg o.d. with regard to the rate of exacerbations during 52 weeks of treatment ;Timepoint(s) of evaluation of this end point: 52 weeks