A randomised parallel group trial to investigate the effect of seretide withdrawal in Chronic Obstructive Pulmonary Disease (COPD) using non-invasive biomarkers and physiological measurements

ISRCTN ISRCTN50541811
DOI https://doi.org/10.1186/ISRCTN50541811
Secondary identifying numbers N0226156349
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
05/04/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Singh
Scientific

Medicines Evaluation Unit
Ledson Road
Wythenshawe
Manchester
M23 9GP
United Kingdom

Phone +44 (0)161 291 2672
Email dsingh@meu.org.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesTo investigate the effect of withdrawal of inhaled seretide on airway inflammation and airflow limitation in Chronic Obstructive Pulmonary Disease (COPD) patients using non-invasive measurement methods and lung function tests.

Please note that this record was extensively updated on the 9th November 2007. Updates were performed to the ethics, inclusion criteria, interventions and secondary outcome measures, as some of this information was not provided in the original record. Where changes have been made, the update date (09/11/2007) has been mentioned. Also please note that previous to this update, the anticipated end date of this trial was 03/07/2006.
Ethics approval(s)Added on 09/11/2007: Ethics approval received from the Central Manchester Local Research Ethics Committee on 25/02/2005.
Health condition(s) or problem(s) studiedChronic Obstructive Pulmonary Disease (COPD)
Intervention1. Seretide withdrawal group (withdrawal of Seretide dose for six weeks)
2. Continuation group

Added on 09/11/2007:
Patients will undergo spirometry, impulse oscillometry, body plethysmography, exhaled breath condensate, exhaled nitric oxide, induced sputum and questionaires at two occasions 2 weeks apart prior to randomisation and then at 2 weekly intervals for 6 weeks.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Seretide
Primary outcome measureInduced sputum inflammatory cell counts
Secondary outcome measuresAdded on 09/11/2007:
1. Exhaled breath condensate pH
2. Exhaled breath condensate Leukotriene B4, 8-isoprostane and other metabolites
3. Exhaled breath condensate and serum metabolite profiling by mass spectrometry
4. Exhaled nitric oxide in parts per billion (at 50 mls/sec, Caw, Calvin and Diffusing Capacity)
5. Induced sputum messenger Ribonucleic Acid (RNA) and protein for inflammatory mediators (e.g., Interleukin-8 [IL-8], Interleukin-6 [IL-6])
6. Sputum and blood gene expression (e.g., glucocorticoid receptor)
7. FEV1, Maximal Expiratory Flow (MEF), FVC (measured by spirometry)
8. Total Lung Capacity (TLC), Residual Volume (RV), Functional Residual Capacity (FRC), Inspiratory Capacity (IC), specific airways conductance (sGaw), airway flow resistance (Raw) (measured by body plethysmography)
9. Resonant Frequency (RF), Respiratory resistance at 5 Hz (R5), reactance at 5 Hz (X5) (measured by impulse oscillometry)
Overall study start date01/03/2005
Completion date31/07/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants24
Key inclusion criteria12 in withdrawal group and 12 in continuation group, patients aged 40 - 75 years

Added on 09/11/2007:
1. Males or females aged 40 - 75 years inclusive
2. Ex smokers or current smokers with a cigarette smoking history of pack years (1 pack-year = 20 cigarettes smoked per day for 1 year or the equivalent)
3. Subjects with Forced Expiratory Volume in one second (FEV1) 50 - 80% of predicted normal for height, age and sex at screening visit
4. Subjects with FEV1/Forced Vital Capacity (FVC) ratio less than 70% at screening visit
5. Patients taking inhaled seretide or combined fluticasone/salmeterol at a dose of 200 - 1000 µg fluticasone and 50 - 100 µg serevent per day
6. Subjects on a stable dose of all COPD treatment over the 4 weeks prior to starting the study
7. Subjects capable of providing signed written consent to participate
Key exclusion criteria1. Subjects taking regular oral leukotriene receptor antagonists, oral cortiscosteroids, inhaled nasal corticosteroids, oral theophylline or inhaled tiotropium for 4 weeks prior to the study start
2. Subjects having one or more exacerbations of COPD in the past 12 months requiring treatment with oral corticosteroids
3. Subjects who have had a previous admission for exacerbation of COPD requiring non-invasive or endo-tracheal intubation or admission to the Intensive Care Unit (ICU)
4. History of asthma or significant atopy/rhinitis (requiring medication)
5. Subjects with uncontrolled angina, myocardial infarction within the last 12 months or congestive cardiac failure
6. Subjects with other significant pulmonary, cardiovascular, neurological, hepatic, renal, endocrine or haematological diseases
7. Female subjects who intend to become pregnant
8. Subjects who have experienced cold or flu-like symptoms or a respiratory infection within 4 weeks of the study start
9. Subjects who have received an investigational drug within 30 days or within 5 drug half-lives of the drug
10. Subjects with a history (or suspected history) of alcohol misuse or any other recreational substance abuse
Date of first enrolment01/03/2005
Date of final enrolment31/07/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Medicines Evaluation Unit
Manchester
M23 9GP
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

South Manchester University Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2009 Yes No