Status:
COMPLETED
Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second \[FEV1\]) over the full 24-h time pe...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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 chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (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/forced vital capacity (FVC) \< 70%
- Exclusion criteria:
- Pregnant or lactating females
- Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
- Patients requiring long term oxygen therapy (\>15 h a day)
- Patient who have had a respiratory tract infection 6 weeks prior to V2 (with further criteria)
- Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
- Patients with history of asthma (with further criteria)
- Patients with Type I or uncontrolled type II diabetes.
- Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
- Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
- Patient with a history with long QT syndrome or whose QTc interval is prolonged
- Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structure
- Patients who have had treatment with an investigational drug (with further criteria)
- Patients who have had live attenuated vaccination within 30 days prior to Visit 2, or during run-in period
- Patients with known history of non compliance to medication
- Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00615030
Start Date
January 1 2008
End Date
August 1 2008
Last Update
August 17 2011
Active Locations (7)
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1
Novartis Investigative Site
Beuvry, France
2
Novartis Investigative Site
Nantes, France
3
Novartis Investigative Site
Berlin, Germany
4
Novartis Investigative Site
Hamburg, Germany