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

Anxiety Clinical Trial

Official title:

The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01522092
• Other study ID #: Escit160710
• Secondary ID: 2010-022038-10
• Status: Withdrawn
• Phase: Phase 3
• First received: January 27, 2012
• Last updated: March 28, 2017

Study information

• Verified date: March 2017
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• escitalopram
5mg-20mg, tablet, od, 12 months

Locations

Country	Name	City	State
United Kingdom	Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital	Cottingham	East Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Hospital Anxiety and depression scale (HADS)	Change in HADS score at 3, 9, and 12 months from baseline	12 months
Secondary	General anxiety disorder(GAD-7)	Change in GAD-7 score at 3,9 and 12 months from baseline	12 months
Secondary	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
Secondary	BODE index	Change in BODE index at 3, 9 and 12months from baseline	12 months
Secondary	Health related utilisation	Number of health related utilisations from baseline to 3, 9 and 12 months	12 months
Secondary	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