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 measure
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
01/10/2020
Reason abandoned (if study stopped)
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
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
Basic results (scientific)
Publication list