4-10 Week Observational Study Comparing 3 Management Strategies for Obstructive Chronic BronchoPneumopathy (OCBP) in Common Clinical Practice

NCT ID: NCT01885247

Last Updated: 2016-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-12-31

Brief Summary

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

The management of patients with Obstructive Chronic BronchoPneumopathy (OCBP) is based on a progression of therapeutic options and on a sensitization to physical activity.

For these patients selected on OCBP stage 2, the treatment options include Long Acting Beta-Agonist Bronchodilator (LABA) or Long Acting Muscarinic Antagonist Anticholinergic (LAMA) or both (LAMA+LABA).

The purpose of this study is to observe in common clinical practice the benefit of physical activity on quality of life, dyspnoea and walking distance for these patients under treatment (LABA and/or LAMA) and to determine whether these 3 medical strategies (LABA/LAMA/LABA+LAMA) benefit from physical activity.

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.

Obstructive Chronic BronchoPneumopathy (OCBP)

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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

Inclusion Criteria

* Patients with Obstructive Chronic BronchoPneumopathy stage ≥ 2.
* Patients under treatment with LABA or LAMA or LABA+LAMA since at least 1 month.
* VEMS/CVF\<70%
* VEMS\<80%
* Patients without regular physical activity and without physical activity program since 1 year.

Exclusion Criteria

* Patients under treatment with LABA + inhaled Corticoids.
* Contraindication to physical activity.
* Patients with previous history of respiratory exacerbations.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Novartis

INDUSTRY

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

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.

Gilles Devouassoux, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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

Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Countries

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

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gilles DEVOUASSOUX, MD, PhD

Role: CONTACT

33 4.26.73.29.47

Isabelle DELFOUR

Role: CONTACT

33 4.26.73.27.25

Other Identifiers

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

2012-746

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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