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
Scientific
Medicines Evaluation Unit
Ledson Road
Wythenshawe
Manchester
M23 9GP
United Kingdom
| Phone | +44 (0)161 291 2672 |
|---|---|
| dsingh@meu.org.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Seretide |
| Primary outcome measure | 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 study start date | 01/03/2005 |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 24 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Medicines Evaluation Unit
Manchester
M23 9GP
United Kingdom
M23 9GP
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
