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

This study is not yet open for participant recruitment.
Verified January 2014 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: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Anxiety
COPD
Drug: escitalopram
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD

Resource links provided by NLM:


Further study details as provided by Hull and East Yorkshire Hospitals NHS Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 Forced expired volume in 1 sec, Forced vital capacity and Peak expiratory flow measured at 3, 9 and 12 months from baseline


Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: escitalopram
escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months
Drug: escitalopram
5mg-20mg, tablet, od, 12 months
Other Name: Cipralex

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522092

Contacts
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

Locations
United Kingdom
Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital Not yet recruiting
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Principal Investigator: Alyn H Morice, Professor         
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Investigators
Principal Investigator: Alyn H Morice, Professor Hull and East Yorkshire Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Prof A H Morice, professor of Respiratory Medicine, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01522092     History of Changes
Other Study ID Numbers: Escit160710, 2010-022038-10
Study First Received: January 27, 2012
Last Updated: January 16, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
Exacerbations

Additional relevant MeSH terms:
Anxiety Disorders
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Mental Disorders
Respiratory Tract Diseases
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on April 17, 2014