ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000458730

Ethics application status

Approved

Date submitted

1/04/2013

Date registered

22/04/2013

Date last updated

22/04/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

Paroxetine for Anxiety in Patients with Chronic Obstructive Pulmonary Disease(emphysema).

Scientific title

Paroxetine for Anxiety in Patients with Chronic Obstructive Pulmonary Disease (COPD).

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1141-2980

Trial acronym

PAC Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

COPD

Condition category

Condition code

Mental Health

Anxiety

Respiratory

Chronic obstructive pulmonary disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Paroxetine 20 mgs daily as oral capsule for 4 months. Adherence and side efects will be monitered by weekly phone calls for first 4 weeks. At the end of 4 months participants will also be asked to return any capsules if remaining to assess overall adherence.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Identical placebo pill (sugar pill) as oral capsule for 4 months

Control group

Placebo

Outcomes

Primary outcome [1]

Anxiety as measured by Beck Anxiety Inventory (mean difference)

Timepoint [1]

4 months and 12 months.

Secondary outcome [1]

Depression as measured by beck Depression inventory (mean difference)

Timepoint [1]

4 months and 12 months.

Secondary outcome [2]

Quality of Life as assessed by Chronic Respiratory Questionnaire (CRQ) (mean difference)

Timepoint [2]

4 months and 12 months.

Secondary outcome [3]

Exercise capacity as measured by 6MWD in meters (mean difference).

Timepoint [3]

4 months and 12 months.

Secondary outcome [4]

Dyspnea as assessed by MMRC dyspnea scale (mean difference as compared with placebo)

Timepoint [4]

4 months and 12 months.

Secondary outcome [5]

Hospital bed utilization/health economics analysis

Timepoint [5]

4 months and 12 months.

Secondary outcome [6]

Lung Function as measured by FEV1

Timepoint [6]

4 months and 12 months.

Secondary outcome [7]

Adverse events will be monitered by weekly phone calls for first four weeks and will also be documented at 4 months visit. Patients will also be advised to report to the investigators of any side effects that they will experience other than these followup calls/visits. Coomon side effects can be:
Central nervous system: Somnolence , insomnia , headache, dizziness.
Endocrine & metabolic: decreased Libido.
Gastrointestinal: Nausea , xerostomia , constipation , diarrhea.
Genitourinary: Ejaculatory disturbances.
Neuromuscular & skeletal: Weakness , tremor Cardiovascular: Chest pain , palpitations.
Dermatologic: Rash.
Ocular: Blurred vision
Miscellaneous: Diaphoresis.

Timepoint [7]

week 1,2,3 &4.
4months and 12 months.

Secondary outcome [8]

Smoking dependence as measured by exhaled carbon monooxide.

Timepoint [8]

4 months and 12 months.

Secondary outcome [9]

Prediction of COPD related mortality as assessed by using BODE index.
BODE: B= BMI in Kgms/m2; O= Obstruction as measured by spirometry in FEV1. ; D= dyspnea as measured by MMRC and E= exercise capacity as measured using 6MWT.

Timepoint [9]

4 months and 12 months.

Eligibility

Key inclusion criteria

Patients with:
COPD, as confirmed by lung function testing ie FEV1/FVC <0.70, and
Anxiety symptoms with Beck Anxiety Inventory (BAI) score of >15.

Minimum age

40 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Severe cognitive impairment.
Terminal cancer.
Pregnancy and lactation.
Unstable psychiatric condition like schizephrenia or active suicidal ideation.
Current use of MAOinhibitors.
Intolerance or allergy to SSRIs.
Prolonged QT interval on ECG.
Current acute exacerbation of COPD
Current use of regular antianxiety and antidepressant medications.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computerised sequence generation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Based on our primary outcome of anxiety as measured by using Beck Anxiety Inventory (BAI), a sample size of 56 in each group will have 80% power to detect a difference in means of 5.0 assuming that the common standard deviation is 9.3 using a two group t-test with a 0.05 two-sided significance level. Since outcome is being measured at baseline and post-intervention, use baseline adjustment reduces the required sample size. Namely, the required sample size is (1 – r2) n where r is the correlation between baseline and post-intervention readings, and n is the above sample size from a simple t-test. Assuming r = 0.5, then the required sample size per group is 0.75n, ie 42 per group. Allowing for 15% withdrawal, we therefore aim to recruit 50 patients per treatment arm.

Descriptive statistics, response rates and follow-up prevalence of anxiety will be calculated. The primary hypothesis comparing prevalence of anxiety after 4 months by treatment arm will be undertaken using a two-sided chi-squared test. A log binomial GLM model will be used to explore changes in anxiety levels over time as part of secondary analyses. The results presented will follow the Consort Statement Performa, and will be on an intention to treat basis. The statistical package STATA 11 and SPSS 19, with intention to treat, will be used for all analyses. Imbalances in all outcome measures at baseline will be controlled using linier regression modeling

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

27/05/2013

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [2]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment hospital [3]

Repatriation Hospital - Daw Park

Recruitment hospital [4]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [5]

Flinders Medical Centre - Bedford Park

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Respiratory Medicine, The Queen Elizabeth Hospital, (TQEH) South Australia, Australia.

Address [1]

4A, TQEH
28 Woodville Road,
Woodville South, SA 5011

Country [1]

Australia

Primary sponsor type

Hospital

Name

Department of Respiratory Medicine, TQEH

Address

4A, TQEH
28 Woodville Road,
Woodville South, SA 5011

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HUMAN RESEARCH ETHICS COMMITTEE (TQEH/LMH/MH)

Ethics committee address [1]

DX 465101
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/01/2012

Approval date [1]

30/04/2012

Ethics approval number [1]

2012012

Summary

Brief summary

An association between increased dyspnoea scores, mood disorders and anxiety levels in patients with COPD has been well established. On a neurochemical level, this association has been further explained in rat models showing that prolonged hypoxia affects the areas of the brain involved in mood control. The understanding of mechanisms of mood control by antidepressants has evolved over time. The strong antidepressant activity of Tricyclic Antidepressants (TCAs) has supported the role of both norepinephrine and serotonin (5-HT) in mood disorders. The next generation of antidepressants included the Selective Serotonin Reuptake Inhibitos (SSRIs), further supporting the role of serotonin. Furthermore, antidepressants have been hypothesised to work in COPD patients by decreasing autonomic over-activity, or detaching excessive distress associated with COPD, thus enabling patients to better endure increased physical activity and physiological changes.

Hence, our hypothesis is that subjects recruited from public hospitals with COPD and clinically significant depression and/or anxiety that are given paroxetine 20 mgs daily  for 4 months will:

(Hypothesis 1: principle hypothesis): have a significant reduction in their anxiety symptoms as compared with the placebo at 4 months follow-up, and;

(Hypothesis 2): these improved levels of anxiety will be associated with:
improved quality of life and exercise capacity, and

(Hypothesis 3): these improved levels of anxiety will be associated with:
a.) a reduction in hospital bed utilisation, and;
b.) a reduction in health care costs in relation to existing practice in long term (12 months)

Trial website

Trial related presentations / publications

Public notes

Primary outcome assessments will occur at 4 months. However in order to assess the longterm effects all the outcomes will be reassessed at 12 months.

Contacts

Principal investigator

Name

Dr Zafar Ahmad Usmani

Address

4A, Department of Respiratory Medicine,
The Queen Elizabeth Hospital (TQEH).
28 Woodville Road,
Woodville South, SA, Australia, 5011

Country

Australia

Phone

61-0438360714

Fax

61882226041

zafar-ahmad.usmani@health.sa.gov.au

Contact person for public queries

Name

Zafar Ahmad Usmani

Address

4A, Department of Respiratory Medicine,
TQEH.
28 Woodville Road,
Woodville South, SA, Australia, 5011

Country

Australia

Phone

61-0438360714

Fax

61882226041

zafar-ahmad.usmani@health.sa.gov.au

Contact person for scientific queries

Name

Zafar Ahmad Usmani

Address

4A, Department of Respiratory Medicine,
TQEH.
28 Woodville Road,
Woodville South, SA, Australia, 5011

Country

Australia

Phone

61-0438360714

Fax

zafar-ahmad.usmani@health.sa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A randomized placebo-controlled trial of paroxetine for the management of anxiety in chronic obstructive pulmonary disease (PAC study).	2018	https://dx.doi.org/10.2147/JMDH.S166022

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically