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Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Primary Purpose

Anxiety, COPD

Status
Withdrawn
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
escitalopram
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Exacerbations

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male/females aged between 40-80 years.
  • Previous diagnosis of COPD confirmed by the GOLD criteria.
  • At least two previous admissions to hospital for acute exacerbation of COPD.
  • Physician diagnosed anxiety
  • At least Mild anxiety score on HADS and GAD-7
  • On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion
  • Known history of cigarette smoking at least 10 pack yrs
  • Willing and able to comply with study procedures
  • Able to provide written informed consent to participate

Exclusion Criteria:

  • Current or past diagnosis of asthma
  • Long-term oxygen therapy
  • Currently on treatment with anti-depressives
  • Serious inter-current illness (eg lung cancer)
  • One year survival considered unlikely
  • Patients who have evidence of alcohol or drug abuse
  • Participation in another clinical trial with an investigational drug in four weeks preceding the screening visit
  • Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
  • Known or suspected hypersensitivity to escitalopram

Sites / Locations

  • Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

escitalopram

Arm Description

escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months

Outcomes

Primary Outcome Measures

exacerbation rate
comparison of the rate of COPD exacerbation in the year preceding treatment with that on escitalopram treatment in patients with COPD adjudged to have a significant element of anxiety.

Secondary Outcome Measures

Quality of life
To assess the effect of escitalopram on the patient's quality of life, as measured by St Georges Respiratory Questionnaire
Hospital Anxiety and depression scale (HADS)
Change in HADS score at 3, 9, and 12 months from baseline
General anxiety disorder(GAD-7)
Change in GAD-7 score at 3,9 and 12 months from baseline
Modified Medical Research Council (MMRC) dyspnoea scale
Change in Modified Medical research council Dyspnoea scale at 3, 9 and 12 months from baseline
BODE index
Change in BODE index at 3, 9 and 12months from baseline
Health related utilisation
Number of health related utilisations from baseline to 3, 9 and 12 months
Spirometry
Change in Forced expired volume in 1 sec, Forced vital capacity and Peak expiratory flow measured at 3, 9 and 12 months from baseline

Full Information

First Posted
January 27, 2012
Last Updated
March 28, 2017
Sponsor
Hull University Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01522092
Brief Title
Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Official Title
The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not given ethical approval- a alternative protocol required
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Anxiety and depression are common in patients with severe chronic obstructive pulmonary disease (COPD). Frequently exacerbation's of breathlessness are associated with panic/fear and indeed this may be the main cause for the for hospital admission. Patients prone to a tendency to experience and communicate somatic distress in response to psychosocial stress and to seek medical help for it are top of the "frequent flyer" league, costing the health care economy dearly. This is a particular problem in Hull with the high levels of smoking and urban deprivation combining to place the city at the bottom of the Department of Health COPD league tables. Our hypothesis is that an effective treatment for anxiety will reduce the number of episodes of hospital admission by reducing the panic/fear element of mild COPD exacerbation's thus allowing the patient time to access the existing community based support services.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, COPD
Keywords
Exacerbations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
escitalopram
Arm Type
Experimental
Arm Description
escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months
Intervention Type
Drug
Intervention Name(s)
escitalopram
Other Intervention Name(s)
Cipralex
Intervention Description
5mg-20mg, tablet, od, 12 months
Primary Outcome Measure Information:
Title
exacerbation rate
Description
comparison of the rate of COPD exacerbation in the year preceding treatment with that on escitalopram treatment in patients with COPD adjudged to have a significant element of anxiety.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
To assess the effect of escitalopram on the patient's quality of life, as measured by St Georges Respiratory Questionnaire
Time Frame
12 months
Title
Hospital Anxiety and depression scale (HADS)
Description
Change in HADS score at 3, 9, and 12 months from baseline
Time Frame
12 months
Title
General anxiety disorder(GAD-7)
Description
Change in GAD-7 score at 3,9 and 12 months from baseline
Time Frame
12 months
Title
Modified Medical Research Council (MMRC) dyspnoea scale
Description
Change in Modified Medical research council Dyspnoea scale at 3, 9 and 12 months from baseline
Time Frame
12 month
Title
BODE index
Description
Change in BODE index at 3, 9 and 12months from baseline
Time Frame
12 months
Title
Health related utilisation
Description
Number of health related utilisations from baseline to 3, 9 and 12 months
Time Frame
12 months
Title
Spirometry
Description
Change in Forced expired volume in 1 sec, Forced vital capacity and Peak expiratory flow measured at 3, 9 and 12 months from baseline
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male/females aged between 40-80 years. Previous diagnosis of COPD confirmed by the GOLD criteria. At least two previous admissions to hospital for acute exacerbation of COPD. Physician diagnosed anxiety At least Mild anxiety score on HADS and GAD-7 On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion Known history of cigarette smoking at least 10 pack yrs Willing and able to comply with study procedures Able to provide written informed consent to participate Exclusion Criteria: Current or past diagnosis of asthma Long-term oxygen therapy Currently on treatment with anti-depressives Serious inter-current illness (eg lung cancer) One year survival considered unlikely Patients who have evidence of alcohol or drug abuse Participation in another clinical trial with an investigational drug in four weeks preceding the screening visit Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus Known or suspected hypersensitivity to escitalopram
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alyn H Morice, Professor
Organizational Affiliation
Hull University Teaching Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital
City
Cottingham
State/Province
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom

12. IPD Sharing Statement

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Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

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