Investigating New Standards for Prophylaxis in Reduction of Exacerbations—The INSPIRE Study Methodology

REFERENCES

• Agusti A G, Noguera A, Sauleda J, Sala E, Pons J, Busquets X. Systemic effects of chronic obstructive pulmonary disease. Eur Respir J 2003; 21(2)347–360
   PubMed Web of Science ®Google Scholar
• Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease—updated 2005. Modena: Global Initiative for Chronic Obstructive Lung Disease. 2005
   Google Scholar
• Agusti A G. COPD, a multicomponent disease: implications for management. Respir Med 2005; 99(6)670–682
   PubMed Web of Science ®Google Scholar
• Gompertz S, Bayley D L, Hill S L, Stockley R A. Relationship between airway inflammation and the frequency of exacerbations in patients with smoking related COPD. Thorax 2001; 56(1)36–41
   PubMed Web of Science ®Google Scholar
• Seemungal T, Harper-Owen R, Bhowmik A, Moric I, Sanderson G, Message S, Maccallum P, Meade T W, Jeffries D J, Johnston S L, Wedzicha J A. Respiratory viruses, symptoms, and inflammatory markers in acute exacerbations and stable chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2001; 164(9)1618–1623
   PubMed Web of Science ®Google Scholar
• Hurst J R, Perera W R, Wilkinson T M, Donaldson G C, Wedzicha J A. Systemic and upper and lower airway inflammation at exacerbation of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2006; 173(1)71–78
   PubMed Web of Science ®Google Scholar
• Burge P S, Calverley P M, Jones P W, Spencer S, Anderson J A, Maslen T K. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. Br J Med 2000; 320(7245)1297–1303
   PubMed Web of Science ®Google Scholar
• Pauwels R A, Lofdahl C G, Laitinen L A, Schouten J P, Postma D S, Pride N B, Ohlsson S V. Long-term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking. European Respiratory Society Study on Chronic Obstructive Pulmonary Disease. N J Engl Med 1999; 340(25)1948–1953
   PubMed Web of Science ®Google Scholar
• Calverley P, Pauwels R, Vestbo J, Jones P, Pride N, Gulsvik A, Anderson J, Maden C. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003; 361(9356)449–456
   PubMed Web of Science ®Google Scholar
• Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, Peterson S, Olsson H. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J 2003; 21(1)74–81
   PubMed Web of Science ®Google Scholar
• Vestbo J. The TORCH (TOwards a Revolution in COPD Health) survival study protocol. Eur Respir J 2004; 24(2)206–210
   PubMed Web of Science ®Google Scholar
• Aaron S D, Vandemheen K, Fergusson D, Fitzgerald M, Maltais F, Bourbeau J, Goldstein R, McIvor A, Balter M, O'Donnell D. The Canadian Optimal Therapy of COPD Trial: design, organization and patient recruitment. Can J Respir 2004; 11(8)581–585
   Google Scholar
• Decramer M, Celli B, Tashkin D P, Pauwels R A, Burkhart D, Cassino C, Kesten S. Clinical trial design considerations in assessing long-term functional impacts of tiotropium in COPD: The Uplift trial. J Chron Obstruct Pulmon Dis 2004; 1(2)303–312
   Google Scholar
• Anthonisen N R, Manfreda J, Warren C P, Hershfield E S, Harding G K, Nelson N A. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med 1987; 106(2)196–204
   PubMed Web of Science ®Google Scholar
• Vincken W, van Noord J A, Greefhorst A P, Bantje T A, Kesten S, Korducki L, Cornelissen P J. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. Eur Respir J 2002; 19(2)209–216
   PubMed Web of Science ®Google Scholar
• Niewoehner D E, Rice K, Cote C, Paulson D, Cooper J A, Jr., Korducki L, Cassino C, Kesten S. Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomised trial. Ann Intern Med 2005; 143(5)317–326
   PubMed Web of Science ®Google Scholar
• Mahler D A, Donohue J F, Barbee R A, Goldman M D, Gross N J, Wisniewski M E, Yancey S W, Zakes B A, Rickard K A, Anderson W H. Efficacy of salmeterol xinafoate in the treatment of COPD. Chest 1999; 115(4)957–965
   PubMed Web of Science ®Google Scholar
• Calverley P M, Boonsawat W, Cseke Z, Zhong N, Peterson S, Olsson H. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Respir J 2003; 22(6)912–919
   PubMed Web of Science ®Google Scholar
• Kardos P, Wencker M, Glaab T, Vogelmeier C. Combination therapy with salmeterol and fluticasone propionate (SFC) is more effective than salmeterol (SAL) alone in reducing exacerbations of COPD. Eur Respir J 2005; 26: 292S, (Suppl 49)
   Google Scholar
• Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. 2006, Executive Summary. NHLBI/WHO Workshop Report
   Google Scholar
• Jones P W, Quirk F H, Baveystock C M. The St George's Respiratory Questionnaire. Respir Med 1991; 85: 25–31, (Suppl B)
   PubMed Web of Science ®Google Scholar
• Andersson F, Borg S, Jansson S A, Jonsson A C, Ericsson A, Prutz C, Ronmark E, Lundback B. The costs of exacerbations in chronic obstructive pulmonary disease (COPD). Respir Med 2002; 96(9)700–708
   PubMed Web of Science ®Google Scholar
• Soler-Cataluna J J, Martinez-Garcia M A, Roman S P, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005; 60(11)925–931
   PubMed Web of Science ®Google Scholar
• Price M J, Hurrell C, Efthimiou J, Medley H V. Health care costs of treating exacerbations of chronic obstructive pulmonary disease (COPD). Eur Respir J 2005; 14: 30S, (Suppl)
   Google Scholar
• European Respiratory Society & European Lung Foundation. European lung white book. The first comprehensive survey on respiratory health in Europe. 2003
   Google Scholar
• Spencer S, Calverley P M, Sherwood B P, Jones P W. Health status deterioration in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2001; 163(1)122–128
   PubMed Web of Science ®Google Scholar
• Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest 2000; 117: 398S–401S, (5 Suppl 2)
   PubMed Web of Science ®Google Scholar
• Pauwels R, Calverley P, Buist A S, Rennard S, Fukuchi Y, Stahl E, Lofdahl C G. COPD exacerbations: the importance of a standard definition. Respir Med 2004; 98(2)99–107
   PubMed Web of Science ®Google Scholar
• Wedzicha J A, Seemungal T A, MacCallum P K, Paul E A, Donaldson G C, Bhowmik A, Jeffries D J, Meade T W. Acute exacerbations of chronic obstructive pulmonary disease are accompanied by elevations of plasma fibrinogen and serum IL-6 levels. Thromb Haemost 2000; 84(2)210–215
   PubMed Web of Science ®Google Scholar
• Spencer S, Jones P W. Time course of recovery of health status following an infective exacerbation of chronic bronchitis. Thorax 2003; 58(7)589–593
   PubMed Web of Science ®Google Scholar
• Sin D D, Wu L, Anderson J A, Anthonisen N R, Buist A S, Burge P S, Calverley P M, Connett J E, Lindmark B, Pauwels R A, Postma D S, Soriano J B, Szafranski W, Vestbo J. Inhaled corticosteroids and mortality in chronic obstructive pulmonary disease. Thorax 2005; 60(12)992–997
   PubMed Web of Science ®Google Scholar
• Wouters E F. Economic analysis of the Confronting COPD survey: an overview of results. Respir Med 2003; 97: S3–14, (Suppl C)
   PubMed Web of Science ®Google Scholar
• Seemungal T A, Donaldson G C, Paul E A, Bestall J C, Jeffries D J, Wedzicha J A. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1998; 157: 1418–1422, (5 Pt 1)
   PubMed Web of Science ®Google Scholar
• Seemungal T A, Donaldson G C, Bhowmik A, Jeffries D J, Wedzicha J A. Time course and recovery of exacerbations in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2000; 161(5)1608–1613
   PubMed Web of Science ®Google Scholar
• Calverley P, Pauwels D R, Lofdahl C G, Svensson K, Higenbottam T, Carlsson L G, Stahl E. Relationship between respiratory symptoms and medical treatment in exacerbations of COPD. Eur Respir J 2005; 26(3)406–413
   PubMed Web of Science ®Google Scholar
• Sin D D, Lacy P, York E, Man S F. Effects of fluticasone on systemic markers of inflammation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004; 170(7)760–765
   PubMed Web of Science ®Google Scholar
• de Torres J P, Cordoba-Lanus E, Lopez-Aguilar C, de Fuentes M M, de Garcini A M, Aguirre-Jaime A, Celli B R, Casanova C. C-reactive protein levels and clinically important predictive outcomes in stable COPD patients. Eur Respir J 2006, Feb 2: [Epub ahead of print]
   Web of Science ®Google Scholar
• Donaldson G C, Seemungal T A, Patel I S, Bhowmik A, Wilkinson T M, Hurst J R, MacCallum P K, Wedzicha J A. Airway and systemic inflammation and decline in lung function in patients with COPD. Chest 2005; 128(4)1995–2004
   PubMed Web of Science ®Google Scholar
• Kanner R E, Anthonisen N R, Connett J E. Lower respiratory illnesses promote FEV(1) decline in current smokers but not ex-smokers with mild chronic obstructive pulmonary disease: results from the lung health study. Am J Respir Crit Care Med 2001; 164(3)358–364
   PubMed Web of Science ®Google Scholar
• Broekhuizen R, Wouters E F, Creutzberg E C, Schols A M. Raised CRP levels mark metabolic and functional impairment in advanced COPD. Thorax 2006; 61(1)17–22
   PubMed Web of Science ®Google Scholar
• Jones P W, Stahl E. Does short-term treatment intensification influence long-term treatment effects on health status in COPD?. Eur Respir J 2005; 26: 293S, (Suppl 49)
   Google Scholar
• Jarad N A, Wedzicha J A, Burge P S, Calverley P M. An observational study of inhaled corticosteroid withdrawal in stable chronic obstructive pulmonary disease. ISOLDE Study Group. Respir Med 1999; 93(3)161–166
   PubMed Web of Science ®Google Scholar
• Stockley R A, Chopra N, Rice L. Addition of salmeterol to existing treatment in patients with COPD: a 12 month study. Thorax 2006; 61(2)122–128
   PubMed Web of Science ®Google Scholar
• Casaburi R, Mahler D A, Jones P W, Wanner A, San P G, Wallack Zu RL, Menjoge S S, Serby C W, Witek T, Jr. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002; 19(2)217–224
   PubMed Web of Science ®Google Scholar