MedDataX Logo

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

NCT ID: NCT01794780

Last Updated: 2019-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-05

Study Completion Date

2015-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00463567

Pulmonary Disease, Chronic Obstructive COPD Lung Diseases, Obstructive
COMPLETED PHASE2/PHASE3

A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

NCT01712516

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00615030

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control

NCT01715311

Chronic Obstructive Pulmonary Disease (COPD)
WITHDRAWN PHASE4

Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01908140

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Indacaterol

LABA: Indacaterol, once a day, 150μg each time

Group Type EXPERIMENTAL

LABA based treatment: indacaterol

Intervention Type DRUG

LABA based treatment: indacaterol

Tiotropium Bromide

LAMA: Tiotropium Bromide, once a day, 18 μg

Group Type EXPERIMENTAL

LAMA based treatment: tiotropium

Intervention Type DRUG

LAMA based treatment: tiotropium

Salmeterol/Fluticasone

LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg

Group Type EXPERIMENTAL

LABA/ICS based treatment: salmeterol/fluticasone

Intervention Type DRUG

LABA/ICS based treatment: salmeterol/fluticasone

Budesonide/ formoterol

Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg

Group Type EXPERIMENTAL

LABA/ICS based treatment: budesonide/formoterol

Intervention Type DRUG

LABA/ICS based treatment: budesonide/formoterol

Indacaterol +Tiotropium

Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg

Group Type EXPERIMENTAL

LABA based treatment: indacaterol

Intervention Type DRUG

LABA based treatment: indacaterol

LAMA based treatment: tiotropium

Intervention Type DRUG

LAMA based treatment: tiotropium

LABA/ICS (Or budesonide/ formoterol)+ Tiotropium

Salmeterol / fluticasone Or budesonide / formoterol

Group Type EXPERIMENTAL

LAMA based treatment: tiotropium

Intervention Type DRUG

LAMA based treatment: tiotropium

LABA/ICS based treatment: salmeterol/fluticasone

Intervention Type DRUG

LABA/ICS based treatment: salmeterol/fluticasone

LABA/ICS based treatment: budesonide/formoterol

Intervention Type DRUG

LABA/ICS based treatment: budesonide/formoterol

Oral theophylline

Group Type EXPERIMENTAL

theophylline based treatment

Intervention Type DRUG

theophylline based treatment

Other treatment

non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"

Group Type EXPERIMENTAL

Other treatment

Intervention Type DRUG

non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LABA based treatment: indacaterol

LABA based treatment: indacaterol

Intervention Type DRUG

LAMA based treatment: tiotropium

LAMA based treatment: tiotropium

Intervention Type DRUG

LABA/ICS based treatment: salmeterol/fluticasone

LABA/ICS based treatment: salmeterol/fluticasone

Intervention Type DRUG

LABA/ICS based treatment: budesonide/formoterol

LABA/ICS based treatment: budesonide/formoterol

Intervention Type DRUG

theophylline based treatment

theophylline based treatment

Intervention Type DRUG

Other treatment

non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Zhengzhou, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Han J, Dai L, Zhong N, Young D. Breathlessness or health status in chronic obstructive pulmonary disease: the impact of different definitions. COPD. 2015 Apr;12(2):115-25. doi: 10.3109/15412555.2014.974741. Epub 2014 Dec 4.

Reference Type DERIVED
PMID: 25474373 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CQAB149BCN01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)
NCT00239421 COMPLETED PHASE4
Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen
NCT01985334 COMPLETED PHASE4
Efficacy of Indacaterol 150 µg Versus Formoterol
NCT01377428 WITHDRAWN PHASE4
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
NCT00900731 COMPLETED PHASE3
Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)
NCT01089127 COMPLETED PHASE3
Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00669617 COMPLETED PHASE3
Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease
NCT01627327 COMPLETED PHASE3
A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
NCT01727141 COMPLETED PHASE3
Lung Function Changes Following the Addition of Formoterol to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02242240 COMPLETED PHASE2
Study in Subjects Greater Than 40 Years of Age With COPD
NCT00507234 COMPLETED PHASE3
Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort
NCT02516592 COMPLETED PHASE4
A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01168310 COMPLETED PHASE2
Effects of Once Daily Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity
NCT00274573 COMPLETED PHASE3
Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00677807 COMPLETED PHASE3
Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients
NCT01727024 COMPLETED PHASE4
Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00435760 COMPLETED PHASE3
Observational Study of Adherence to LABA / LAMA in Chronic Obstructive Pulmonary Disease (COPD)
NCT01937390 COMPLETED
A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149
NCT01709903 COMPLETED PHASE3
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00794157 COMPLETED PHASE3
Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD
NCT02059434 COMPLETED PHASE1
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT01437540 COMPLETED PHASE3
Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01604278 COMPLETED PHASE3
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
NCT00393458 COMPLETED PHASE3
Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo
NCT01049360 COMPLETED PHASE2
Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
NCT01572792 COMPLETED PHASE3