A 12-week treatment, multi-center, randomized, parallel group, blinded, double dummy study to compare the efficacy and safety of Indacaterol (150 µg o.d.) delivered via a SDDPI with Tiotropium (18 µg o.d.) delivered via a HandiHaler®, in patients with moderate-to-severe COPD.
- Conditions
- COPD (chronic obstructive pulmonary disease)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2009-010665-23-AT
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1600
Male and female adults aged = 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2007) and including:
a. Smoking history of at least 10 pack years
b. Post-bronchodilator FEV1 < 80% and = 30% of the predicted normal value.
c. Post-bronchodilator FEV1/FVC < 70%.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (>5 mIU/mL)
2.Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, including women whose career, lifestyle, or sexual orientation
precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the definition of postmenopausal (given in the protocol).
Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation
3.Patients with a body mass index (BMI) of more than 40 kg/m2
4.Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid
treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening.
5.Patients requiring oxygen therapy for chronic hypoxemia (excluding acute COPD
exacerbation).
6. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2. Patients who develop a respiratory tract infection between Visit 2 and Visit 4 must discontinue from the trial, but may be re-screened at a later date once the inclusion/exclusion criteria have been met.
7. Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless
confirmed by chest x-ray to be no longer active), or clinically significant bronchiectasis
8.Patients with a history (up to and including Visit 2) of asthma indicated by (but not limited to):
a) onset of respiratory symptoms (such as cough, wheezing, shortness of breath)
suggestive of asthma prior to age 40 years
b) history of a diagnosis of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1c > 8.0 % of total hemoglobin measured at Visit 2
9.Patients with contraindications for tiotropium treatment including medical history of
symptomatic prostatic hypertrophy, bladder neck obstruction, narrow angle glaucoma and moderate to severe renal impairment (creatinine clearance = 50 mL/min)
10.Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding chronic stable atrial fibrillation) or other clinically significant ECG findings, uncontrolled hypertension and other significant cardiac disease or conduction defect, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the opinion of investigator or Novartis responsible personnel might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
11.Patients with lung cancer or a history of lung cancer
12.Patients with active malignancy or a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, with
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate non-inferiority of indacaterol (150 µg o.d.) versus tiotropium (18 µg o.d.) with respect to trough Forced Expiratory Volume in one second (trough FEV1) 24h post dose after 12 weeks (84 days) of treatment in patients with moderate to severe COPD. Trough refers to the mean of FEV1 at 23:10h and 23:45h after the morning dose of study drug.;Secondary Objective: To demonstrate superiority of indacaterol (150 µg o.d.) versus tiotropium (18 µg o.d.) with respect to trough FEV1 24h post dose after 12 weeks (84 days) of treatment<br>;Primary end point(s): To demonstrate non-inferiority of indacaterol (150 µg o.d.) versus tiotropium (18 µg o.d.) with respect to trough Forced Expiratory Volume in one second (trough FEV1) 24h post dose after 12 weeks (84 days) of treatment in patients with moderate to severe COPD. Trough refers to the mean of FEV1 at 23:10h and 23:45h after the morning dose of study drug.
- Secondary Outcome Measures
Name Time Method