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Richard J. Martin, MD, FCCP; James T. Good, MD, FCCP; Steve D. Groshong, MD, PhD; Christena A. Kolakowski, MS
Author and Funding Information

From the Division of Pulmonary and Critical Care Medicine (Drs Good and Martin and Ms Kolakowski), Division of Pathology (Dr Groshong), Department of Medicine, National Jewish Health and the University of Colorado Denver.

Correspondence to: Richard J. Martin, MD, FCCP, 1400 Jackson St, J206, Denver, CO 80206; e-mail: martinr@njhealth.org


Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interests: Dr Martin has done consultancy work and/or received travel support and/or honoraria for attendance at speaking activities and/or advisory boards for Teva Pharmaceuticals Ltd; Merck & Co, Inc; AstraZeneca; Genentech, Inc/Novartis AG; KaloBios Pharmaceuticals, Inc; Graceway Pharmaceuticals, LLC; and Lek dd; received research grants from Genentech, Inc (murine mast cell) and the National Heart, Lung, and Blood Institute (murine and human models); and received royalties from UpToDate, Inc. Dr Good has done consultancy work and/or received travel support and/or honoraria for attendance at speaking activities and/or advisory boards for AstraZeneca; Genentech, Inc; and GlaxoSmithKline and received research grants from Genentech, Inc. Dr Groshong has received research grants from the National Institutes of Health. Ms Kolakowski has reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2012;142(3):810-811. doi:10.1378/chest.12-1079
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To the Editor:

We appreciate the comments by Drs Rehman and deBoisblanc. These concerns were addressed within our article,1 but are important to address further.

The first comment was regarding the lack of a separate control arm and, thus, the possibility of a placebo effect from individualized therapy. As discussed in our publication, we compared two groups of patients; we did not use a true, matched, placebo control. The first was the initial 20 patients with defined refractory asthma2 who were referred for evaluation and treatment at National Jewish Health. These patients then had an additional 4 months of intensified treatment without any improvement in the FEV1 or the Asthma Control Test.1 Only after specific directed therapy, with a reduction in other asthma-related medications, did these outcomes improve.1 If a placebo effect were to explain the outcomes, then after being referred to a tertiary/quaternary center, changing medications, and so forth, one would expect to see some placebo effect occurring after the additional 4 months of treatment, but no such improvement was observed.

The second group was the nonspecific group, which did have bronchoscopy and guideline-based increase in therapy. This group did not have a significant improvement in FEV1 or the Asthma Control Test. Thus, the question would be: Why is this group immune to the placebo effect?

The second comment by Drs Rehman and deBoisblanc is somewhat unclear to us. We strictly defined this group of patients as refractory, the definition of which dictates at least 1 year of high-dose therapies.2 We agree with the correspondents that bronchoscopy in patients who are “getting out of control” not only “limits evaluation” of bronchoscopy, but should not be done. We cannot comment on regression to the mean as we were not investigating “out of control” patients.

Finally, our study was more of a real-world investigation, not a randomized control trial (RCT). Both are valuable, and both have associated problems. It is poorly perceived that RCTs are only able to enroll about 3% to 5% of the entire asthma population due to inclusion/exclusion criteria,3,4 yet this type of evaluation is then expanded to include the entire asthma population. If our study could possibly be developed into an RCT, which is doubtful, then both types of research would complement each other.

Good JT Jr, Kolakowski CA, Groshong SD, Murphy JR, Martin RJ. Refractory asthma: importance of bronchoscopy to identify phenotypes and direct therapy. Chest. 2012;141(3):599-606. [PubMed] [CrossRef]
 
American Thoracic Society Proceedings of the ATS workshop on refractory asthma: current understanding, recommendations, and unanswered questions. Am J Respir Crit Care Med. 2000;162(6):2341-2351. [PubMed]
 
Travers J, Marsh S, Williams M, et al. External validity of randomised controlled trials in asthma: to whom do the results of the trials apply?. Thorax. 2007;62(3):219-223. [PubMed] [CrossRef]
 
Herland K, Akselsen JP, Skjønsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger “real life” population of patients with obstructive lung disease?. Respir Med. 2005;99(1):11-19. [PubMed] [CrossRef]
 

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References

Good JT Jr, Kolakowski CA, Groshong SD, Murphy JR, Martin RJ. Refractory asthma: importance of bronchoscopy to identify phenotypes and direct therapy. Chest. 2012;141(3):599-606. [PubMed] [CrossRef]
 
American Thoracic Society Proceedings of the ATS workshop on refractory asthma: current understanding, recommendations, and unanswered questions. Am J Respir Crit Care Med. 2000;162(6):2341-2351. [PubMed]
 
Travers J, Marsh S, Williams M, et al. External validity of randomised controlled trials in asthma: to whom do the results of the trials apply?. Thorax. 2007;62(3):219-223. [PubMed] [CrossRef]
 
Herland K, Akselsen JP, Skjønsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger “real life” population of patients with obstructive lung disease?. Respir Med. 2005;99(1):11-19. [PubMed] [CrossRef]
 
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