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

This study is not yet open for participant recruitment.
Verified September 2012 by Hull and East Yorkshire Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01522092
First received: January 27, 2012
Last updated: September 11, 2012
Last verified: September 2012
History of Changes

January 27, 2012
September 11, 2012
October 2012
January 2014   (final data collection date for primary outcome measure)
exacerbation rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01522092 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in HADS score at 3, 9, and 12 months from baseline
  • General anxiety disorder(GAD-7) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in GAD-7 score at 3,9 and 12 months from baseline
  • Modified Medical Research Council (MMRC) dyspnoea scale [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Change in Modified Medical research council Dyspnoea scale at 3, 9 and 12 months from baseline
  • BODE index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in BODE index at 3, 9 and 12months from baseline
  • Health related utilisation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of health related utilisations from baseline to 3, 9 and 12 months
  • Spirometry [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in FEV1, FVC and PEF measured at 3, 9 and 12 months from baseline
Same as current
Not Provided
Not Provided
 
Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD

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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anxiety
  • COPD
Drug: escitalopram
5mg-20mg, tablet, od, 12 months
Other Name: Cipralex
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
November 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact: Caroline E Wright, BSc 01482 624067 ext 3782 c.e.wright@hull.ac.uk
Contact: Jackie Mower, RGN 01482 624009 jackie.mower@hey.nhs.uk
United Kingdom
 
NCT01522092
Escit160710, 2010-022038-10
No
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust
Hull and East Yorkshire Hospitals NHS Trust
Not Provided
Principal Investigator: Alyn H Morice, Professor Hull and East Yorkshire Hospitals NHS Trust
Hull and East Yorkshire Hospitals NHS Trust
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP