Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 8.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: indacaterol
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
Pharmaceutical form of the placebo: Inhalation powde
Sponsors
NovartisPharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female adults aged = 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure 2.Co-operative outpatients with a diagnosis of COPD according to the GOLD Guidelines (2005) and: a)Smoking history of at least 20 pack years b)Pre-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing women 2. Women of child-bearing potential UNLESS they meet a pre-defined definition of post-menopausal, OR are using one or more pre-specified acceptable methods of contraception: 3. Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 2 or during the run-in period. 4. Patients requiring long term oxygen therapy for chronic hypoxemia. 5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2. 6. Patients with concomitant pulmonary disease including a history of lung cancer, pulmonary tuberculosis or clinically significant bronchiectasis. 7. Patients with a history (up to Visit 2) of asthma indicated by (but not limited to): a) Blood eosinophil count > 400/mm3 b) Onset of symptoms prior to age 40 years. 8. 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 > 6.5% of total Hb. 9. 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 stable AF), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigator’s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study. 10. Any patient with lung cancer or other active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable. 11. Patients with a history of long QT syndrome or prolonged QTc (Bazett’s) intervals > 450 ms (males) or > 470 ms (females) 12. Patients with a history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof. 13. Patients who do not maintain regular day/night, waking/sleeping cycles 14. Patients who have had treatment with other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 15. Patients who have had live attenuated vaccinations within 30 days prior to Visit 2 and during the run-in period. (Influenza vaccination is acceptable provided it is not administered within 48 h prior to Visits 1 or 2). 16. Treatments for COPD and allied conditions: the following medications must not be used prior to Visit 2 for at least the minimum washout period specified below or at any time during the study: a) The long acting anti-cholinergic agent tiotropium: 7 days b) Short acting anti-cholinergics: 8 h c) Fixed combinations of beta-2-agonists and inhaled corticosteroids: 48 h (Patients taking fixed dose combination therapy must switch to inhaled corticosteroid as monotherapy plus salbutamol/albuterol as rescue therapy) d) Long-acting beta-2-agonists: 48 h e) Short acting beta-2-agonists (other than those prescribed in the study): 6 h f) Theophylline and other xanthines: 1 week g) Parenteral or oral corticosteroids: 1 month 17. Treatments for COPD and allied conditions: The following medications should not be used unless they have been s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess indacaterol (300 & 600 µg o.d. via SDDPI) superiority in patients with COPD as compared to placebo with respect to 24 h post dose (trough) FEV1 after 12 weeks of treatment; Secondary Objective: KEY:Effect of indacaterol (300 & 600 µg o.d.) on % ‘days of poor control’ over 52 weeks, versus placebo. Effect of indacaterol versus placebo on the following: St Georges Respiratory Questionnaire, after 12 weeks Time to first COPD exacerbation over 52 weeks QoL after 4, 8, 12, 24, 44 and 52 weeks. COPD exacerbation rates over 52 weeks TDI focal score after 4, 8, 12, 24, 44 and 52 weeks. Trough FEV1 measured on Day 2 and after 52 weeks. Spirometry at all time points with respect to early, peak and trough response. Morning and evening PEF, clinical symptoms and use of rescue medication over 52 weeks. •Long term tolerability and safety (ECG, laboratory tests, blood pressure, and adverse events). ;Primary end point(s): The primary objective is to determine if indacaterol 600 µg is superior to placebo and indacaterol 300 µg is superior to placebo with respect to 24 hour post dose (trough) FEV1 in patients with COPD following 12 weeks of treatment. | — |
Countries
Belgium, Czech Republic, Denmark, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Slovakia, Sweden, United Kingdom
Outcome results
None listed