Condition category
Musculoskeletal Diseases
Date applied
14/07/2010
Date assigned
14/07/2010
Last edited
02/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nick Hopkinson

ORCID ID

Contact details

Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom
-
n.hopkinson@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8238

Study information

Scientific title

Impact of smoking cessation on skeletal muscle atrophy and hypertrophy pathways in chronic obstructive pulmonary disease (COPD)

Acronym

Study hypothesis

Our hypothesis is that smoking cessation in patients with chronic obstructive pulmonary disease (COPD) will lead to an increase in skeletal muscle bulk and endurance and that this will be associated with alterations in the pathways controlling skeletal muscle atrophy and hypertrophy including the Akt/FOXO/atrogene, mTOR and MyoD and myostatin pathways. We also propose that smoking cessation will lead to a more oxidative fibre type with an increase in the expression of type I myosin and reduction in the expression of type II myosin heavy chains. We will investigate this by making detailed assessment of skeletal muscle function and examining biopsies from the quadriceps muscle before and after smoking cessation.

In parallel with this we will study the effect of smoking cessation on lung function, exercise capacity and systemic inflammation.

Ethics approval

UCLH Committee Alpha approved (ref: 09/H0715/37)

Study design

Single-centre observational non-randomised diagnosis and screening cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal

Intervention

Smoking cessation advice, counselling and pharmacotherapy as clinically indicated. This may include NRT and varenicline. Outcomes will be assessed 8 weeks after the quit date.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Activity of the IGF-1 PI3K/Akt/FOXO/atrogene pathway and the mTOR pathway in muscle biopsy specimens, measured at 8 weeks after quit date

Secondary outcome measures

Measured at 8 weeks after quit date:
1. Dynamic hyperinflation during cycle ergometry
2. MyoD and myostatin protein and mRNA levels
3. Quadriceps endurance
4. Quadriceps strength

Overall trial start date

01/11/2009

Overall trial end date

15/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consenting adult smokers who wish to quit
2. Both COPD patients who smoke and smokers with normal lung function
3. Male and female, lower age limit of 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 95; UK sample size: 95

Participant exclusion criteria

The presence of significant co-morbidity judged likely to have a significant impact on muscle strength

Recruitment start date

01/11/2009

Recruitment end date

15/08/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton Hospital
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Imperial College
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes