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Journal of Allergy and Clinical Immunology

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Control of airway inflammation maintained at a lower steroid dose with 100/50 μg of fluticasone propionate/salmeterol - 17/08/11

Doi : 10.1016/j.jaci.2006.03.043 
Nizar N. Jarjour, MD a, Susan J. Wilson, PhD b, Steven M. Koenig, MD c, Michel Laviolette, MD d, Wendy C. Moore, MD e, W. Bruce Davis, MD f, Dennis E. Doherty, MD g, Qutayba Hamid, MD h, Elliott Israel, MD i, Mani S. Kavuru, MD j, Joe W. Ramsdell, MD k, Donald P. Tashkin, MD l, Donna S. Reilly, BS m, Steven W. Yancey, MS m, Lisa D. Edwards, PhD m, John L. Stauffer, MD m, Paul M. Dorinsky, MD m, Ratko Djukanovic, MD b, ⁎
a From the Pulmonary and Critical Care Medicine Section, the University of Wisconsin School of Medicine, Madison 
b University of Southampton 
c Division of Pulmonary Medicine and Critical Care, University of Virginia, Charlottesville 
d Laval Hospital and University, Montreal 
e Division of Pulmonary and Critical Care Medicine, Wake Forest University School of Medicine, Winston-Salem 
f Medical College of Georgia, Augusta 
g University of Kentucky, Lexington 
h Meakins Christie Laboratories, McGill University, Montreal 
i Brigham and Women’s Hospital, Harvard Medical School, Boston 
j Cleveland Clinic Foundation 
k University of California at San Diego Clinical Trials Center 
l University of California at Los Angeles 
m Respiratory Medicine Development Center, GlaxoSmithKline, Research Triangle Park 

Reprint requests: Ratko Djukanovic, MD, Southampton General Hospital, Tremona Rd, Southampton, SO16 6YD United Kingdom.

Madison, Wis, Southampton, United Kingdom, Charlottesville, Va, Montreal, Quebec, Canada, Winston-Salem and Research Triangle Park, NC, Augusta, Ga, Lexington, Ky, Boston, Mass, Cleveland, Ohio, and San Diego and Los Angeles, Calif

Abstract

Background

Inhaled corticosteroids (ICSs) have been shown to reverse epithelial damage and decrease lamina reticularis thickness in patients with asthma.

Objective

This study investigated whether clinical asthma control and airway inflammation could be maintained after switching therapy from medium-dose fluticasone propionate (FP) to low-dose FP administered with the long-acting β2-agonist (LABA) salmeterol.

Methods

Eighty-eight subjects (age, ≥18 years) who, during open-label screening, demonstrated improved asthma control after an increase from 100 μg of FP twice daily to 250 μg of FP twice daily were randomized to receive 100/50 μg of FP/salmeterol through a Diskus inhaler (GlaxoSmithKline, Research Triangle Park, NC) twice daily or continue 250 μg of FP twice daily through a Diskus inhaler for 24 weeks. Clinical outcomes were monitored, and bronchial biopsy specimens and bronchoalveolar lavage fluid were obtained before and after 24 weeks of treatment.

Results

There were no significant differences between treatments with respect to eosinophils in the bronchial mucosa and bronchoalveolar lavage fluid; mucosal mast cells, neutrophils, or CD3+, CD4+, CD8+, or CD25+ T lymphocytes; or concentration of mediators (GM-CSF, IL-8, and eosinophil cationic protein). The 2 treatments were not different with respect to lamina reticularis thickness. Consistent with the airway inflammatory measures, clinical and physiologic measures of asthma control were also similar.

Conclusion

This study demonstrates that control of asthma and airway inflammation is maintained over the 24-week treatment period when patients requiring a medium-dose ICS are switched to a lower-dose ICS with a LABA.

Clinical implications

A lower-dose ICS with a LABA is effective in controlling inflammation and providing clinical asthma control, confirming current guideline recommendations.

Le texte complet de cet article est disponible en PDF.

Key words : Fluticasone propionate, salmeterol, biopsy, bronchoalveolar lavage, eosinophils

Abbreviations used : BAL, BALF, COPD, ECP, FP, FSC, ICS, IQR, LABA, PEF


Plan


 Supported by GlaxoSmithKline, Research Triangle Park, NC.
Presented in part at the American Thoracic Society Annual Meeting; May 21-26, 2004; Orlando, Fla.
Disclosure of potential conflict of interest: P. M. Dorinsky, L. D. Edwards, and D. S. Reilly are all employed by GlaxoSmithKline. W. C. Moore, J. W. Ramsdell, and Q. Hamid have all received grant support from GlaxoSmithKline. S. W. Yancey and J. L. Stauffer are both employed by and own stock in GlaxoSmithKline. N. N. Jarjour has consultant arrangements with Asthmatax, has received grant support from GlaxoSmithKline, and is on the speakers’ bureau for Schering-Plough. S. M. Koenig has received grant support from GlaxoSmithKline, AstraZeneca, and ONO and is on the speakers’ bureau for Boehringer-Ingelheim, Pfizer, GlaxoSmithKline, AstraZeneca, Merck, and Schering-Plough. D. E. Doherty has received clinical trial funding from Altana, Boehringer-Ingelheim, GlaxoSmithKline, and Novartis. E. Israel has consultant arrangements with Asthmatax, Merck, Novartis, Protein Design Labs, Schering-Plough, and Wyeth; has received grant support from AstraZeneca, Genentech, Merck, Boehringer-Ingelheim, GlaxoSmithKline, and Wyeth; and receives lecture fees from Genentech and Merck. M. S. Kavuru has received grant support from and is on the speakers’ bureau for GlaxoSmithKline and Genentech. D. P. Tashkin has received grant support from and conducted preceptorships for GlaxoSmithKline. R. Djukanovic has consultant arrangements with Aventis and Synairgen, owns stock in Synairgen, and has received grant support from GlaxoSmithKline and AstraZeneca. The rest of the authors have declared that they have no conflict of interest.


© 2006  American Academy of Allergy, Asthma and Immunology. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 118 - N° 1

P. 44-52 - juillet 2006 Retour au numéro
Article précédent Article précédent
  • Atopic dermatitis
  • Mark Boguniewicz, Peter Schmid-Grendelmeier, Donald Y.M. Leung
| Article suivant Article suivant
  • Prevention of asthma during the first 5 years of life: A randomized controlled trial
  • Guy B. Marks, Seema Mihrshahi, Andrew S. Kemp, Euan R. Tovey, Karen Webb, Catarina Almqvist, Rosario D. Ampon, Daniel Crisafulli, Elena G. Belousova, Craig M. Mellis, Jennifer K. Peat, Stephen R. Leeder, for the Childhood Asthma Prevention Study team

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