A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD
Intervention: LABA based treatment: indacaterol (Drug); LAMA based treatment: tiotropium (Drug); LABA/ICS based treatment: salmeterol/fluticasone (Drug); LABA/ICS based treatment: budesonide/formoterol (Drug); theophylline based treatment (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact: Novartis Pharmaceuticals, Phone: +41613241111
Summary
This multi-center study is designed to describe natural history of disease, treatment and
health care products in physician-diagnosed COPD patients who require adding daily
maintenance therapy in real world.
Clinical Details
Official title: A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Secondary outcome: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)COPD exacerbation Questionnaire MMRC Questionnaire CAT Questionnaire TDI
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Willing and able to provide informed consent
- Physician-diagnosis of COPD
- COPD patients requiring long-acting bronchodilator treatment
- Patients with spirometry available at baseline
Exclusion Criteria:
- Patients who have a diagnosis of asthma.
- Patients who had been hospitalized for a COPD exacerbation in the 4 weeks prior to
Visit 1.
- Current clinical diagnosis of other chronic respiratory illnesses
- Concurrent participation in a clinical trial or use of an investigational drug.
- Active malignancy or history of malignancy of any organ system
- Pregnant or nursing (lactating) women
- Women of child-bearing potential with no contraception Other protocol-defined
inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis Pharmaceuticals, Phone: +41613241111
Novartis Investigative Site, Beijing 100730, China; Recruiting
Novartis Investigative Site, Zhengzhou, China; Not yet recruiting
Additional Information
Starting date: February 2013
Last updated: January 2, 2015
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