Escitalopram in Anxiety Associated Chronic Obstructive Pu... | NCT01522092

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

NCT01522092

Sponsor

Hull University Teaching Hospitals NHS Trust

Status

Withdrawn

Last Update Posted

Mar 29, 2017Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Anxiety
COPD

Interventions

escitalopram

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-022038-10	EudraCT Number

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was not given ethical approval- a alternative protocol required

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 27, 2012

First Submission Date that Met QC Criteria

Jan 30, 2012

First Posted Date

Jan 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2017

Last Update Posted Date

Mar 29, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof A H Morice, professor of Respiratory Medicine, Hull University Teaching Hospitals NHS TrustPrincipal Investigator

Lead Sponsor

Hull University Teaching Hospitals NHS TrustOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
escitalopram	Experimental	escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months	Drug: escitalopram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
escitalopram	Drug	5mg-20mg, tablet, od, 12 months	escitalopram	Cipralex

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alyn H Morice, Professor	Hull University Teaching Hospitals NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital		Cottingham	East Yorkshire	HU16 5JQ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D001523	Mental Disorders
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000089983	Escitalopram
D003909	Dexetimide

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572

Browse Leaves

Not provided

Browse Branches

Not provided