Condition category
Respiratory
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
05/04/2011
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 David Singh

ORCID ID

Contact details

Medicines Evaluation Unit
Ledson Road
Wythenshawe
Manchester
M23 9GP
United Kingdom
+44 (0)161 291 2672
dsingh@meu.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226156349

Study information

Scientific title

Acronym

Study hypothesis

To 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

Added on 09/11/2007: Ethics approval received from the Central Manchester Local Research Ethics Committee on 25/02/2005.

Study design

Randomised controlled trial

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 the contact details below to request a patient information sheet

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Intervention

1. 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 type

Drug

Phase

Not Specified

Drug names

Seretide

Primary outcome measures

Induced sputum inflammatory cell counts

Secondary outcome measures

Added 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 trial start date

01/03/2005

Overall trial end date

31/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

12 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. 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

Recruitment start date

01/03/2005

Recruitment end date

31/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medicines Evaluation Unit
Manchester
M23 9GP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

South Manchester University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19603154

Publication citations

  1. Results

    Borrill Z, Roy K, Kolsum U, Southworth T, Vestbo J, Singh D, Seretide withdrawal increases airway inflammation in moderate COPD patients., Eur. J. Clin. Pharmacol., 2009, 65, 11, 1165-1166, doi: 10.1007/s00228-009-0697-5.

Additional files

Editorial Notes