| April 28, 2008 |
| September 1, 2008 |
| April 2008 |
| August 2008 (final data collection date for primary outcome measure) |
| Forced expiratory volume in 1 second (FEV1) at 5 mins post dose of indacaterol (150 and/or 300 μg) as compared to placebo |
| Same as current |
| Complete list of historical versions of study NCT00669617 on ClinicalTrials.gov Archive Site |
- FEV1 at 5 mins post dose of indacaterol (150 and 300 μg) versus salmeterol/fluticasone (50/500 μg)
- FEV1 at 5 mins post dose of indacaterol (150 and 300 μg) versus salbutamol (200 μg)
- FEV1 at 5 mins post dose of salmeterol/fluticasone (50/500 μg) and salbutamol (200 μg) versus placebo
|
| Same as current |
| |
| Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |
| A Phase III, Randomized, Double-Blind, Triple-Dummy, Placebo Controlled, Multicenter, 5-Period, Single-Dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls |
This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to salbutamol 200 µg and salmeterol/fluticasone 50/500 µg |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
| Chronic Obstructive Pulmonary Disease |
- Drug: Indacaterol 150 µg
- Drug: Indacaterol 300 µg
- Drug: Salmeterol/fluticasone (50/500 μg)
- Drug: Salbutamol 200 µg
- Drug: Placebo
|
- Experimental: Indacaterol 150 µg single dose, delivered via single-dose dry powder inhaler (SDDPI)
- Experimental: Indacaterol 300 µg single dose, delivered via single-dose dry powder inhaler (SDDPI)
- Active Comparator: Salmeterol/fluticasone (50/500 μg) fixed-dose combination delivered via manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI)
- Active Comparator: Salbutamol 200 μg delivered via manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI)
- Placebo Comparator: Placebo delivered via matching devices
|
| |
| |
| Completed |
| 75 |
| August 2008 |
| August 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
- Patients with a diagnosis of COPD (moderate-to-severe as classified by the GOLD Guidelines, 2006) and:
- Smoking history of at least 20 pack years
- Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value.
- Post-bronchodilator FEV1/FVC < 70%, where FVC is forced vital capacity ('Post-' refers to 15-30 mins after inhalation of 400 μg of salbutamol at Visit 2)
Exclusion Criteria:
- Pregnant / nursing women or women of child-bearing potential
- Long term oxygen therapy (more than 15h per day) on a daily basis for chronic hypoxemia
- Patients hospitalized for COPD exacerbation in 6 weeks prior to Visit 2 and up to Visit 3
- Respiratory tract infection within 6 weeks prior to Visit 2 and up to Visit 3
- Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
- Any history of asthma, including: blood eosinophil count >400/mm3; onset of asthma symptoms prior to age 40 years
- History of long QT syndrome or whose QTc (Bazett's) measured at Visit 2 or Visit 3 is prolonged (>450ms for males or >470ms for females)
- Clinically relevant lab abnormalities / conditions 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
- Uncontrolled Type I / Type II Diabetes or blood glucose outside normal or HbA1c >8.0% of total hemoglobin measured at Visit 2
- Any patient with lung cancer or any active cancer or a history of cancer with less than 5 years disease-free survival time
- History of hypersensitivity to any of the study drugs
- Irregular day/night, waking/sleeping cycles e.g. shift workers
- Live attenuated vaccinations within 30 days prior to Visit 2
- Investigational drug within 30 days prior to Visit 2
- Known history of non-compliance or not able to use devices or perform spirometry Other protocol-defined inclusion/exclusion criteria may apply
|
| Both |
| 40 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Belgium, Germany, Hungary |
| |
| NCT00669617 |
| External Affairs, Novartis |
| CQAB149B2307, EUDRACT: 2007-006189-14 |
| Novartis |
|
|
| Novartis |
| September 2008 |