Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Product Name: Indacaterol
Product Code: QAB149
Pharmaceutical Form: Inhalation powder
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use
Trad
Sponsors
Novartis Pharma 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 (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 following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH 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: IUD, 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, post-ovulation 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 who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period 4. Patients requiring long term (> 6 months) oxygen therapy for chronic hypoxemia. (‘prn’ use up to 10 h total in any given 24 h period is acceptable) 5. 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 3 must discontinue from the trial, but may be permitted to re-enroll at a later date (at least 6 weeks after the start of the respiratory tract infection). 6. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis 7. Patients with a history (up to Visit 1) of asthma indicated by (but not limited to): a) Blood eosinophil count > 400/mm3 b) Onset of respiratory 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 > 8.0% of total Hb measured at Visit 1 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, 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 a history of lung cancer 11. Any patient with 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess indacaterol (200 & 400 µg o.d. via Certihaler) 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: To evaluate the effect of indacaterol (200 & 400 µg o.d. via Certihaler) on the following: 1.Number of ‘days of poor control’ reported over the 52 week randomized treatment period, as compared to placebo. 2.Effect on the St Georges Respiratory Questionnaire (SGRQ), as compared with placebo after 12 weeks treatment as compared with placebo 3.Effect on time to first exacerbation during the 52-week randomised treatment period as compared with placebo. For other secondary objectives see protocol.;Primary end point(s): The primary objective is to determine if indacaterol (200 & 400 µg o.d.) is superior to placebo with respect to 24 hour post dose (trough) FEV1 in patients with COPD following 12 weeks of treatment. The trough in FEV1 is defined as the average of the 23 h 30 min and the 23 h 55 min values taken in the clinic at Visits 4 (Day 2), 9 (Week 13) and 17 (Week 53) only. At all other visits the trough in FEV1 is defined as the value taken in the clinic at 5 minutes prior to dosing. The baseline measurement is defined as the average of the FEV1 values taken in the clinic at 30 and 5 minutes prior to dosing at Visit 3. The primary variable is ‘trough FEV1’ at Visit 9. | — |
Countries
Germany, Sweden, United Kingdom
Outcome results
None listed