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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

Page last updated: August 23, 2015

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