AnxietyPhase 3NCT01522092
Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
A Phase 3 study testing escitalopram in people with Anxiety and COPD, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital
Cottingham, East Yorkshire, HU16 5JQ
About this study
Official title: 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.
- Being tested
- escitalopram
- Keywords
- Exacerbations
- Medical subject headings
- Anxiety Disorders, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
Also called Cipralex
5mg-20mg, tablet, od, 12 months
| Study group | Role | What they receive |
|---|---|---|
| escitalopram | Experimental | escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months Receives: Drug: escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Quality of life
To assess the effect of escitalopram on the patient's quality of life, as measured by St Georges Respiratory Questionnaire
Measured: 12 months
Hospital Anxiety and depression scale (HADS)
Change in HADS score at 3, 9, and 12 months from baseline
Measured: 12 months
General anxiety disorder(GAD-7)
Change in GAD-7 score at 3,9 and 12 months from baseline
Measured: 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
Measured: 12 month
BODE index
Change in BODE index at 3, 9 and 12months from baseline
Measured: 12 months
Health related utilisation
Number of health related utilisations from baseline to 3, 9 and 12 months
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
Why it stopped: Study was not given ethical approval- a alternative protocol required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof A H Morice, Hull University Teaching Hospitals NHS Trust
- Investigators
- Alyn H Morice, Professor, Principal investigator, Hull University Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522092
- Sponsor's protocol ID
- Escit160710
- Other IDs
- 2010-022038-10
- Status last verified
- Mar 2017
- First submitted
- 27 Jan 2012
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD
- ClinicalTrials.gov ID
- NCT01522092
- Acronym / sponsor ID
- Escit160710
- Keywords
- Exacerbations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not given ethical approval- a alternative protocol required
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| escitalopram | Experimental | Drug: escitalopramescitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| escitalopramAlso: Cipralex5mg-20mg, tablet, od, 12 months | Drug | escitalopram |
Primary outcome
exacerbation rate
Time frame: 12 months
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.
7 secondary outcomes
Quality of life
Time frame: 12 months
Hospital Anxiety and depression scale (HADS)
Time frame: 12 months
General anxiety disorder(GAD-7)
Time frame: 12 months
Modified Medical Research Council (MMRC) dyspnoea scale
Time frame: 12 month
BODE index
Time frame: 12 months
Health related utilisation
Time frame: 12 months
Spirometry
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyn H Morice, Professor principal investigator
Hull University Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing escitalopram in people with Anxiety and COPD, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exacerbation rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.