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.

Study Overview

• Status: Withdrawn
• Conditions: Anxiety; COPD
• Intervention / Treatment: Drug: escitalopram

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • East Yorkshire
    • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
      • Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Cipralex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	To assess the effect of escitalopram on the patient's quality of life, as measured by St Georges Respiratory Questionnaire	12 months
Hospital Anxiety and depression scale (HADS)	Change in HADS score at 3, 9, and 12 months from baseline	12 months
General anxiety disorder(GAD-7)	Change in GAD-7 score at 3,9 and 12 months from baseline	12 months
Modified Medical Research Council (MMRC) dyspnoea scale	Change in Modified Medical research council Dyspnoea scale at 3, 9 and 12 months from baseline	12 month
BODE index	Change in BODE index at 3, 9 and 12months from baseline	12 months
Health related utilisation	Number of health related utilisations from baseline to 3, 9 and 12 months	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	12 months

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Investigators: Principal Investigator: Alyn H Morice, Professor, Hull University Teaching Hospitals NHS Trust

Study record dates

Study Registration Dates

• First Submitted: January 27, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (Estimate): January 31, 2012

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Exacerbations
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: Escit160710; 2010-022038-10 (EudraCT Number)