Condition category
Respiratory
Date applied
04/11/2015
Date assigned
11/11/2015
Last edited
09/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name used to refer to a number of progressive, devastating and debilitating lung diseases, which includes chronic bronchitis, emphysema and chronic obstructive airways disease. People that have COPD typically feel breathless after physical activity, have a persistent cough with phlegm and suffer frequently from chest infections. Modafinil is a drug licensed for the excessive sleepiness disorder of “narcolepsy”. This tablet has been given to patients with type-2 respiratory failure with COPD. It has found to lead to an improvement in blood oxygen levels and a reduction in blood carbon dioxide levels. This tablet has been given for this condition for 8-10 years but permission to continue to do so is being restricted without formal study data. To take this treatment forward, a formal study needs to be run on a group of patients with raised blood carbon dioxide levels to monitor the improvement under study conditions.

Who can participate?
Patients aged 40-86 with long term high blood carbon dioxide levels and COPD who are not using a nasal ventilator.

What does the study involve?
At the start of the study, each participants medical history is taken and they undergo blood tests. They also complete questionnaires; these ask about sleepiness, respiratory symptoms and also symptoms of anxiety or depression. They are also asked to take a lung function test, have their arterial blood gases taken and have their overnight blood oxygen levels measured (overnight oximetry). Once these tests are complete, each participant is randomly allocated into one of two groups. Those in group 1 are given 200mg of modafinil in pill form every morning in addition to their standard care for 40 days. Those in group 2 (the control group) receive their standard care only. All participants then visit the study centre on three further occasions, once within 10-14 days of the treatment starting, once within 1 month of the treatment starting and once after 40 days of treatment. During these visits oxygen saturation levels, lung function and arterial blood gases are all measured and another questionnaire, identical to the one at the start of the study, is completed. Finally, within one week of the end of the study, all participants receive a follow-up telephone call.

What are the possible benefits and risks of participating?
The potential benefits include reduced blood carbon dioxide levels. Previous studies have shown improvements in overnight sleeping oxygen levels. Risks include rashes, nausea or vomiting. Patients who drink heavily should avoid modafinil along with those with significant liver or kidney disease.

Where is the study run from?
St Helier Hospital, Surrey (UK)

When is the study starting and how long is it expected to run for?
October 2015 to October 2018

Who is funding the study?
St Helier Hospital (charity account)

Who is the main contact?
Dr Veronica Varney
veronica.varney@esth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Veronica Varney

ORCID ID

Contact details

Respiratory Dept
St Helier Hospital
Wrythe Lane
Carshalton
Surrey
SM51AA
United Kingdom
0208 296 2401
veronica.varney@esth.nhs.uk

Additional identifiers

EudraCT number

2013-005107-13

ClinicalTrials.gov number

Protocol/serial number

Protocol Number: 002083935121

Study information

Scientific title

A study to assess the benefit of modafinil in COPD with type-2 respiratory failure: an open randomised study

Acronym

MICOPD

Study hypothesis

The proposed study is a “proof of concept” open randomised study to standardise the data collection so that pilot data can be collected in a standardised fashion from which bigger studies can be planned according to the study findings.

1. Primary objective: assess the efficacy of modafinil on arterial oxygen improvement and blood carbon dioxide reduction at 10 days and 40 days of treatment
2. Secondary objectives: assess the effects of modafinil on day and overnight oximetry measurements and quality of life measures ( HAD, BODE, ESS, MRC5P) and spirometry

Ethics approval

NRES Committee London - Surrey Borders Research Ethics Committee (REC) London Centre, 27/01/2015, ref: 14/LO/2225

Study design

Open randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

COPD with type-2 respiratory failure

Intervention

Visit 1: Each participants medical history is taken and baseline blood tests done. Participants also complete questionnaires, take a lung function test, have arterial blood gas and overnight oximetry assessed. Each participant is then randomly allocated to one of two groups. Those in group 1 are given oral modafinil (200mg) every morning and standard care for 40 days. Those in group 2 (control) are given their usual standard care.
Visit 2 takes place within 10-14 days of study start and oxygen saturation levels, lung function, arterial blood gas and overnight oximetry are assessed. Questionnaires are also completed.
Visits 3 takes place 1 month after the start of the study. Oxygen saturation levels, lung function, arterial blood gas and overnight oximetry are assessed once more and questionnaires completed.
Final visit takes place after 40 days of treatment. after 40 days of treatment where all measurements are taken a final time.
All participants receive a final follow-up phone call within one week of the end of the study.

Intervention type

Drug

Phase

Not Specified

Drug names

Modafinil 200mg mane

Primary outcome measures

The primary efficacy endpoints for the trial will be a change from baseline in arterial oxygen and carbon dioxide levels at 10 days (steady state drug levels) and 40 days

Secondary outcome measures

Secondary endpoints will be change from baseline at 10 and 40 days in:
1. Spirometry (FEV1, FVC, PEFR)
2. Symptom score on the MMRC Scale.
3. Mean overnight oxygen saturations
4. Epworth sleepiness score
5. Respiratory rate at rest
6. BODE score and GAD-7 score
7. Resting oxygen saturation on air
8. Occurrence of hospital admissions or exacerbations

Overall trial start date

21/10/2015

Overall trial end date

21/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or menopausal females aged 40 – 86 years
2. Negative pregnancy test in women at entry to study with a raised FSH level if under 60yrs old
3. Acceptable ECG on entry to study
4. An established clinical history consistent with COPD and known chronic hypercapnic respiratory failure on standard treatments
5. Arterial gases confirming known hypercapnia with PaO2 below 8.1kPa and arterial carbon dioxide level >7.5 kPa in the absence of an exacerbation
6. No use of oxygen or nasal ventilator nor CPAP machine
7. Able to comply with questionnaires and assessments
8. No history of significant renal or liver failure or uncontrolled hypertension and epilepsy that would preclude the use of modafinil
9. No history of significant psychological disturbances
10. No drugs that are likely to interact with modafinil
11. No evidence of current left cardiac failure
12. Compliant with all standard COPD treatments including inhalers, nebulizers and theophyllines and steroids to optimize COPD care

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 (20 active modafinil with standard care and 20 open standard care)

Participant exclusion criteria

1. Hypercapnic respiratory failure only during an acute COPD exacerbation
2. A recognized coexisting respiratory disorder that in the opinion of the investigator would put the patient at risk or invalidate the study outcome measures
3. Epilepsy, significant psychological disorders, un-controlled hypertension, known significant liver or kidney disease
4. Non-menopausal women including pregnant and breast feeding women or those sexually active and taking contraception (both oral and barrier method). This will be checked by a FSH level also

Recruitment start date

21/10/2015

Recruitment end date

21/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Helier Hospital
Wrythe Lane Carshalton
Surrey
SM5 1AA,
United Kingdom

Sponsor information

Organisation

St Helier Hospital, R&D Dept

Sponsor details

Wrythe Lane
Carshalton
Surrey
SM51AA
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Not defined

Funder name

St Helier Hospital (charity account)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

25/01/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes