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

NHS Trust

Status and phase

Withdrawn

Phase 3

Conditions

COPD

Anxiety

Treatments

Drug: escitalopram

Study type

Interventional

Funder types

Other

Identifiers

NCT01522092

2010-022038-10 (EudraCT Number)

Escit160710

Details and patient eligibility

About

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.

Sex

All

Ages

40 to 80 years old

Volunteers

No 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