Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? – study protocol for a randomized controlled trial [NCT00120978]
<p>Abstract</p> <p>Background</p> <p>Systemic inflammation is associated with various complications in chronic obstructive pulmonary disease including weight loss, cachexia, osteoporosis, cancer and cardiovascular diseases. Inhaled corticosteroids attenuate airway infla...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2006-02-01
|
| Series: | BMC Pulmonary Medicine |
| Online Access: | http://www.biomedcentral.com/1471-2466/6/3 |
| _version_ | 1811252850555092992 |
|---|---|
| author | Ramesh Warren Mainra Rajesh R York Ernest Wong Eric FitzGerald Mark Ford Gordon Marciniuk Darcy D Man SF Paul Sin Don D Melenka Lyle S Wilde Eric Cowie Robert L Williams Dave Rousseau Roxanne |
| author_facet | Ramesh Warren Mainra Rajesh R York Ernest Wong Eric FitzGerald Mark Ford Gordon Marciniuk Darcy D Man SF Paul Sin Don D Melenka Lyle S Wilde Eric Cowie Robert L Williams Dave Rousseau Roxanne |
| author_sort | Ramesh Warren |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Systemic inflammation is associated with various complications in chronic obstructive pulmonary disease including weight loss, cachexia, osteoporosis, cancer and cardiovascular diseases. Inhaled corticosteroids attenuate airway inflammation, reduce exacerbations, and improve mortality in chronic obstructive pulmonary disease. Whether inhaled corticosteroids by themselves or in combination with a long-acting β<sub>2</sub>-adrenoceptor agonist repress systemic inflammation in chronic obstructive pulmonary disease is unknown. The Advair Biomarkers in COPD (ABC) study will determine whether the effects of inhaled corticosteroids alone or in combination with a long-acting β<sub>2</sub>-adrenoceptor agonist reduce systemic inflammation and improve health status in patients with chronic obstructive pulmonary disease.</p> <p>Methods/Design</p> <p>After a 4-week run-in phase during which patients with stable chronic obstructive pulmonary disease will receive inhaled fluticasone (500 micrograms twice daily), followed by a 4-week withdrawal phase during which all inhaled corticosteroids and long acting β<sub>2</sub>-adrenoceptor agonists will be discontinued, patients will be randomized to receive fluticasone (500 micrograms twice daily), fluticasone/salmeterol combination (500/50 micrograms twice daily), or placebo for four weeks. The study will recruit 250 patients across 11 centers in western Canada. Patients must be 40 years of age or older with at least 10 pack-year smoking history and have chronic obstructive pulmonary disease defined as forced expiratory volume in one second to vital capacity ratio of 0.70 or less and forced expiratory volume in one second that is 80% of predicted or less. Patients will be excluded if they have any known chronic systemic infections, inflammatory conditions, history of previous solid organ transplantation, myocardial infarction, or cerebrovascular accident within the past 3 months prior to study enrolment. The primary end-point is serum C-reactive protein level. Secondary end-points include circulating inflammatory cytokines such as interleukin-6 and interleukin-8 as well as health-related quality of life and lung function.</p> <p>Discussion</p> <p>If inhaled corticosteroids by themselves or in combination with a long-acting β<sub>2</sub>-adrenoceptor agonist could repress systemic inflammation, they might greatly improve clinical prognosis by reducing various complications in chronic obstructive pulmonary disease.</p> |
| first_indexed | 2024-04-12T16:40:53Z |
| format | Article |
| id | doaj.art-f2f9f4b1935c48d98f6b1fadceb80df2 |
| institution | Directory Open Access Journal |
| issn | 1471-2466 |
| language | English |
| last_indexed | 2024-04-12T16:40:53Z |
| publishDate | 2006-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pulmonary Medicine |
| spelling | doaj.art-f2f9f4b1935c48d98f6b1fadceb80df22022-12-22T03:24:47ZengBMCBMC Pulmonary Medicine1471-24662006-02-0161310.1186/1471-2466-6-3Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? – study protocol for a randomized controlled trial [NCT00120978]Ramesh WarrenMainra Rajesh RYork ErnestWong EricFitzGerald MarkFord GordonMarciniuk Darcy DMan SF PaulSin Don DMelenka Lyle SWilde EricCowie Robert LWilliams DaveRousseau Roxanne<p>Abstract</p> <p>Background</p> <p>Systemic inflammation is associated with various complications in chronic obstructive pulmonary disease including weight loss, cachexia, osteoporosis, cancer and cardiovascular diseases. Inhaled corticosteroids attenuate airway inflammation, reduce exacerbations, and improve mortality in chronic obstructive pulmonary disease. Whether inhaled corticosteroids by themselves or in combination with a long-acting β<sub>2</sub>-adrenoceptor agonist repress systemic inflammation in chronic obstructive pulmonary disease is unknown. The Advair Biomarkers in COPD (ABC) study will determine whether the effects of inhaled corticosteroids alone or in combination with a long-acting β<sub>2</sub>-adrenoceptor agonist reduce systemic inflammation and improve health status in patients with chronic obstructive pulmonary disease.</p> <p>Methods/Design</p> <p>After a 4-week run-in phase during which patients with stable chronic obstructive pulmonary disease will receive inhaled fluticasone (500 micrograms twice daily), followed by a 4-week withdrawal phase during which all inhaled corticosteroids and long acting β<sub>2</sub>-adrenoceptor agonists will be discontinued, patients will be randomized to receive fluticasone (500 micrograms twice daily), fluticasone/salmeterol combination (500/50 micrograms twice daily), or placebo for four weeks. The study will recruit 250 patients across 11 centers in western Canada. Patients must be 40 years of age or older with at least 10 pack-year smoking history and have chronic obstructive pulmonary disease defined as forced expiratory volume in one second to vital capacity ratio of 0.70 or less and forced expiratory volume in one second that is 80% of predicted or less. Patients will be excluded if they have any known chronic systemic infections, inflammatory conditions, history of previous solid organ transplantation, myocardial infarction, or cerebrovascular accident within the past 3 months prior to study enrolment. The primary end-point is serum C-reactive protein level. Secondary end-points include circulating inflammatory cytokines such as interleukin-6 and interleukin-8 as well as health-related quality of life and lung function.</p> <p>Discussion</p> <p>If inhaled corticosteroids by themselves or in combination with a long-acting β<sub>2</sub>-adrenoceptor agonist could repress systemic inflammation, they might greatly improve clinical prognosis by reducing various complications in chronic obstructive pulmonary disease.</p>http://www.biomedcentral.com/1471-2466/6/3 |
| spellingShingle | Ramesh Warren Mainra Rajesh R York Ernest Wong Eric FitzGerald Mark Ford Gordon Marciniuk Darcy D Man SF Paul Sin Don D Melenka Lyle S Wilde Eric Cowie Robert L Williams Dave Rousseau Roxanne Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? – study protocol for a randomized controlled trial [NCT00120978] BMC Pulmonary Medicine |
| title | Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? – study protocol for a randomized controlled trial [NCT00120978] |
| title_full | Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? – study protocol for a randomized controlled trial [NCT00120978] |
| title_fullStr | Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? – study protocol for a randomized controlled trial [NCT00120978] |
| title_full_unstemmed | Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? – study protocol for a randomized controlled trial [NCT00120978] |
| title_short | Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? – study protocol for a randomized controlled trial [NCT00120978] |
| title_sort | can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease study protocol for a randomized controlled trial nct00120978 |
| url | http://www.biomedcentral.com/1471-2466/6/3 |
| work_keys_str_mv | AT rameshwarren caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT mainrarajeshr caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT yorkernest caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT wongeric caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT fitzgeraldmark caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT fordgordon caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT marciniukdarcyd caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT mansfpaul caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT sindond caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT melenkalyles caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT wildeeric caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT cowierobertl caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT williamsdave caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 AT rousseauroxanne caninhaledfluticasonealoneorincombinationwithsalmeterolreducesystemicinflammationinchronicobstructivepulmonarydiseasestudyprotocolforarandomizedcontrolledtrialnct00120978 |