A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator

August 27, 2019 updated by: Novartis Pharmaceuticals

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.

The study planned to enroll 550 patients in Indacaterol group and 9450 patients in non- Indacaterol group, a total of 10,000 patients. Enrollment was stopped at 2253 patients due to low recruitment in indacaterol group. Finally a total of 2229 patients were analyzed in full analysis set.

A total of 2253 patients entered into the database, of which 24 patients were exclude during the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a total of 2229 patients enrolled successfully.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2229

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Novartis Investigative Site
      • Zhengzhou, China
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Indacaterol
LABA: Indacaterol, once a day, 150μg each time
Drug: LABA based treatment: indacaterol
LABA based treatment: indacaterol
EXPERIMENTAL: Tiotropium Bromide
LAMA: Tiotropium Bromide, once a day, 18 μg
Drug: LAMA based treatment: tiotropium
LAMA based treatment: tiotropium
EXPERIMENTAL: Salmeterol/Fluticasone
LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg
Drug: LABA/ICS based treatment: salmeterol/fluticasone
LABA/ICS based treatment: salmeterol/fluticasone
EXPERIMENTAL: Budesonide/ formoterol
Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg
Drug: LABA/ICS based treatment: budesonide/formoterol
LABA/ICS based treatment: budesonide/formoterol
EXPERIMENTAL: Indacaterol +Tiotropium
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
Drug: LABA based treatment: indacaterol
LABA based treatment: indacaterol
Drug: LAMA based treatment: tiotropium
LAMA based treatment: tiotropium
EXPERIMENTAL: LABA/ICS (Or budesonide/ formoterol)+ Tiotropium
Salmeterol / fluticasone Or budesonide / formoterol
Drug: LAMA based treatment: tiotropium
LAMA based treatment: tiotropium
Drug: LABA/ICS based treatment: salmeterol/fluticasone
LABA/ICS based treatment: salmeterol/fluticasone
Drug: LABA/ICS based treatment: budesonide/formoterol
LABA/ICS based treatment: budesonide/formoterol
EXPERIMENTAL: Oral theophylline
Drug: theophylline based treatment
theophylline based treatment
EXPERIMENTAL: Other treatment
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
Drug: Other treatment
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline,3 months
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. Pulmonary function tests were performed at study visits including FEV1, and Force Vital Capacity (FVC). These were performed 30 minutes before treatment and not more than 2 hours in advance after stopping the Long-acting bronchodilators eight hours before visits. In order to reduce the variation between each test, the same instrument was used in the whole research process if condition allowed.
Baseline,3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline,12 months
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. Pulmonary function tests were performed at study visits including FEV1, and Force Vital Capacity (FVC). These were performed 30 minutes before treatment and not more than 2 hours in advance after stopping the long-acting bronchodilators eight hours before visits. In order to reduce the variation between each test, the same instrument was used in the whole research process if condition allowed.
Baseline,12 months
COPD Exacerbation
Time Frame: Baseline,12 months
Number of COPD exacerbations evaluated over 12 months. COPD exacerbation is defined as a new onset or worsening of at least 1 respiratory major symptoms (e.g. dyspnea, cough, sputum volume or sputum purulence) for at least 3 consecutive days, which results in recorded treatment change (antibiotics/steroids/oxygen therapy) OR recorded COPD related hospitalization/Emergency visit. COPD exacerbation is not considered as adverse event, and should only be recorded in COPD e-CRF.
Baseline,12 months
Change in Health Status Questionnaire MMRC
Time Frame: Baseline,3,6,9,12 months
The mMRC scale is scored from 0 (less severe) to 4 (severe). 0 Not troubled with breathlessness except with strenuous exercise; 1 Troubled by shortness of breath when hurrying on the level or walking up a slight hill; 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level; 3 Stops for breath after walking about 100 yards or after a few minutes on the level; 4 Too breathless to leave the house or breathless when dressing or undressing. The modified Medical Research Council (mMRC) Dyspnea Scale , is a five-item instrument (part of the Borg scale) to assess a patient's degree of breathlessness in relation to physical activity. Participants will be required to read a brief description of an activity and then select a statement that best describes their experience with dyspnea at Visit 101. The mMRC was assessed by the investigators at the scheduled visits.
Baseline,3,6,9,12 months
Change From Baseline in Questionnaire COPD Assessment Test (CAT) Score
Time Frame: Baseline,3,6,9,12 months
The COPD assessment test (CAT) is a short instrument scale used to quantify the symptom burden of COPD and will be used to assess the health status of patients in this study. It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.
Baseline,3,6,9,12 months
Change From Baseline Questionnaire Transition Dyspnea Index (TDI) Score
Time Frame: Baseline,3,6,9,12 months
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. BDI/TDI was used to assess dyspnea from several aspects, caused by daily activities. These were evaluated by the investigators in the study at the scheduled study visits. The indices were to be evaluated by the same investigator.as far as possible.
Baseline,3,6,9,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 5, 2013

Primary Completion (ACTUAL)

May 25, 2015

Study Completion (ACTUAL)

May 25, 2015

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 15, 2013

First Posted (ESTIMATE)

February 20, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAB149BCN01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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