moderate COPD MedDRA version: 12.0 Level: LLT Classification code 10029978 Term: Obstructive chronic bronchitis with acute exacerbation
Conditions
Interventions
Product Name: Indacaterol Maleate
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol maleate
CAS Number: 753498-25-8
Current Sponsor code: QAB14
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfil all of the following criteria: 1. Male and female adults aged ≥ 40 years who have signed an Informed Consent Form before any assessment is performed. 2. Co-operative outpatients with a clinical diagnosis of moderate COPD (moderate as classified by the GOLD Guidelines, 2007 (Appendix 1), confirmed by spirometry and including all of the following: a) Smoking history of at least 10 pack years (both current and ex-smokers); b) FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to Visit 1. In the event of an exacerbation occurring during the run-in period (Visits 1-2), the patient must be discontinued from the study. The patient may be re-screened once the inclusion/exclusion criteria have been met. 2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection between Visit 1 and Visit 2 must discontinue from the trial, but may be permitted to re-enroll at a later date once the inclusion/exclusion criteria have been met. 3. Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis or clinically significant bronchiectasis. 4. Patients with alpha-1-antitrypsin deficiency. 5. 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). 6. Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes. 7. Patients whose body mass index is less than 15 or greater than 40 kg/m2. 8. Any patient with lung cancer or a history of lung cancer. 9. 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 human chorionic gonadotrophin (hCG) laboratory test (> 5 mIU/mL). 10. 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 following definition of postmenopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels >40 mIU/mL or are using one or more of the following acceptable methods of contraception: a) surgical sterilization (e.g. bilateral tubal ligation, hysterectomy); b) hormonal contraception (implantable, patch, oral); c) double-barrier methods (any double combination of: intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). 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. 11. Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that a single dose of indacaterol 150 μg is non inferior to a single dose of tiotropium 18 μg with regard to the Inspiratory Capacity (IC) peak value (defined as maximum value within 4 h after inhalation).;Secondary Objective: Key: To demonstrate that single dose of indacaterol 150 μg is superior to single dose of tiotropium 18 μg with regard to the IC peak value (defined as maximum value within 4 h after inhalation). Other Secondary: To compare indacaterol versus tiotropium efficacy in terms of FEV1 across the 4 hours of dosing. To compare indacaterol versus tiotropium efficacy in terms of Forced Volume Capacity (FVC) across the 4 hours of dosing. To compare indacaterol versus tiotropium efficacy in terms of Total Lung Capacity (TLC) across the 4 hours of dosing. To compare indacaterol versus tiotropium efficacy in terms of Airway Resistance (Raw) across the 4 hours of dosing.;Primary end point(s): To demonstrate that a single dose of indacaterol 150 μg is non inferior to a single dose of tiotropium 18 μg with regard to the Inspiratory Capacity (IC) peak value (defined as maximum value within 4 h after inhalation). | — |
Countries
Italy
Outcome results
None listed