NCT01627743

Brief Summary

This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice, the possible corelation between patIent perception of the ability to perform morning activities and physician evaluation; patients with COPD, grade C and D.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
505

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

6 months

First QC Date

June 22, 2012

Last Update Submit

February 20, 2013

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

CDLMvisual scale - physician evaluationCOPDGOLD group C and D

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in Capacity of Daily Living during the Morning (CDLM) Questionnaire

    CDLM questionnaire is a simple self-reporting tool of the burden and ability of COPD patients to perform routine morning activities: washing, dressing, eating breakfast, walking around. For each of these morning activities the score is varying from 0 (indicating worst case) to 5 (indicating best case).

    Baseline and 3 months

  • Change from baseline of patient's general health status based upon physician evaluation - visual scale

    General health status visual scale is assessing the physicians perception of the patient health status following the clinical examination. Based upon clinical evaluation, the physician will indicate the patient's general condition on a a scale consisting of 5 levels. The scale will be completed at each visit and the score can vary from 1(very bad general health status) to 5 (very good general health status) .

    Baseline and 3 months

Secondary Outcomes (4)

  • Demographic patient characteristics

    Day 0 (visit1)

  • Patient adherence to treatment - visual scale

    up to 3 months

  • Number of daily walking steps (using pedometer)

    up to 3 months

  • Number of exacerbations

    up to 3 months

Study Arms (1)

COPD patients grade C and D

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients, group C and D according to GOLD guidelines 2011, being treated for at least 1 month with combination ICS/LABA treatment

You may qualify if:

  • Diagnosis of COPD, grade C and D according to GOLD Guidelines Revised 2011
  • Current or past smokers, of at least 10 pack years
  • Receive any inhaled combination therapy for COPD (inhaled corticosteroid / long acting β2-agonist bronchodilator) initiated for at least one month before entering in the study

You may not qualify if:

  • History of exacerbation of COPD symptoms within the last month before visit 1, inclusive; history of asthma or allergic rhinitis; history of lung carcinoma or any other respiratory condition that may limit the airflow circulation
  • Inability to understand study procedures and inability/refuse to complete CDLM questionnaires and/or record the values showed on the pedometer screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Research Site

Bacau, Romania

Location

Research Site

Botoșani, Romania

Location

Research Site

Bucharest, Romania

Location

Research Site

Buzău, Romania

Location

Research Site

Călăraşi, Romania

Location

Research Site

Cluj-Napoca, Romania

Location

Research Site

Constanța, Romania

Location

Research Site

Craiova, Romania

Location

Research Site

Drobeta-Turnu Severin, Romania

Location

Research Site

Fălticeni, Romania

Location

Research Site

Focşani, Romania

Location

Research Site

Iași, Romania

Location

Research Site

Leordeni, Romania

Location

Research Site

Luduş, Romania

Location

Research Site

Oradea, Romania

Location

Research Site

Ploieşti, Romania

Location

Research Site

Râmnicu Vâlcea, Romania

Location

Research Site

Reghin, Romania

Location

Research Site

Slatina, Romania

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Florin Mihaltan, PROFESSOR

    University of Medicine and Pharmacy Carol Davila, Bucharest, Romania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2012

First Posted

June 26, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 21, 2013

Record last verified: 2013-02

Locations

RO(19)