Inhaled Bronchodilator Association and Quality of Life in... | NCT02176564

Studies
Inhaled Bronchodilator Association and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

NCT02176564

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 18, 2014Estimated

Enrollment

2,639Actual

Phase

Not provided

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

inhaled bronchodilator

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1999

Primary Completion Date

Oct 2000Actual

Completion Date

Not provided

First Submitted Date

Jun 26, 2014

First Submission Date that Met QC Criteria

Jun 26, 2014

First Posted Date

Jun 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2014

Last Update Posted Date

Jul 18, 2014Estimated

Description Module

Brief Summary

A pharmaco-epidemiological, observational study that aimed at assessing in a prospective manner the evolution of Quality of Life (QOL) in chronic obstructive pulmonary disease (COPD) patients treated with inhaled bronchodilators

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,639Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chronic obstructive pulmonary disease		Patients with COPD treated with inhaled bronchodilators	Drug: inhaled bronchodilator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inhaled bronchodilator	Drug		Chronic obstructive pulmonary disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of health-related quality of life (Short-Form Health Survey)		4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of COPD confirmed by Pulmonary Function Test (PFTs)
Recent treatment with a free or fixed association of inhaled bronchodilators

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with COPD

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided