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Patient Outcome of Invasive Experiments

We appreciate and share Dr. Pechlaner's interest in patient safety. Our research program has a longstanding interest in the safety of bronchoalveolar lavage and segmental bronchoprovocation with allergen (1, 2). Two of us (W.W.B. and N.N.J.) were members of an NIH Workshop on Investigative Bronchoprovocation and Bronchoscopy in Airway Disease held in July 2003 (Busse WW, Wanner A, Adams K, Reynolds HY, Castro M, Chowdhury B, Kraft M, Levine RL, Peters SP, Sullivan L. Workshop on investigative bronchoprovocation and bronchoscopy in airway disease. Submitted manuscript.)

In the article cited by Dr. Pechlaner (3), segmental bronchoprovocation with allergen was performed in 16 allergic subjects with mild asthma. Bronchoalveolar lavage was repeated 48 hours later. Utmost precautions were taken to ensure subjects' safety. Before study, subjects underwent physical examination by a physician, were determined to be healthy (except for allergy and asthma), and had normal pulmonary function. Segmental bronchoprovocation and bronchoalveolar lavage were performed by pulmonary physicians experienced in research bronchoscopies, assisted by a certified Clinical Research nurse. Finally, these studies are IRB approved and reviewed annually by a Research Subject Advocate from our NIH-sponsored General Clinical Research Center.

To prevent bronchospasm, subjects were premedicated with inhaled albuterol (180 µg) and intramuscular glycopyrrolate (200 µg). Oxygen saturation was monitored continuously and supplemental oxygen delivered when necessary to keep saturation more than or equal to 90%. Heart rate and symptoms were recorded before, during, and after bronchoscopy. Spirometry was done before and after each procedure. None of the subjects developed acute bronchospasm or significant airflow limitation. FEV₁ was 94 (79–120)% of predicted (mean with range) immediately before and 94 (74–116)% of predicted immediately after bronchoscopy with segmental bronchoprovocation. Forty-eight hours later, there was only a modest reduction in FEV₁ to 92 (78–115)% of predicted, p = 0.065. During both bronchoalveolar lavage and segmental bronchoprovocation, oxygen saturation remained greater than 92% in 15 subjects. In one subject, oxygen saturation briefly dropped to 84% during the lavage 48 hours after segmental bronchoprovocation, returning to 99% on room air by discharge. Heart rate increased from 77 (58–100) beats/minute (mean with range) at baseline to 88 (68–108) (p = 0.003) beats/minute during bronchoalveolar lavage and 88 (68–104) beats/minute during segmental bronchoprovocation (p = 0.054), returning to 76 (63–94) beats/minute by discharge.

Subjects were contacted 12 and 24 hours after each bronchoscopy to follow up on symptoms, peak flow values, and need for medication. Reported symptoms after bronchoscopy with segmental bronchoprovocation with allergen included mild fatigue (5 subjects), headache (3 subjects), cough (3 subjects), wheeze/chest tightness/lung congestion (4 subjects), and sore/dry throat (12 subjects). Seven subjects used albuterol inhaler within 24 hours of bronchoscopy; none required a follow-up visit due to complications.

Adherence to well-designed safety protocols allows segmental bronchoprovocation and bronchoalveolar lavage to be safely performed. As in any research procedure, risk–benefit considerations should be carefully considered, and attention to subject safety is an essential responsibility of every investigator.

Elizabeth A. Kelly, Nizar N. Jarjour, William W. Busse and Linying Liu

University of Wisconsin School of Medicine Madison, Wisconsin

Acknowledgments

W.W.B. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript; N.N.J. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript; L.L. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript; E.A.K. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript.

REFERENCES

1. Djukanovic R, Dahl R, Jarjour N, Aalbers R. Safety of biopsies and bronchoalveolar lavage. Eur Respir J Suppl 1998;26:39S–41S.[Medline]
2. Jarjour NN, Peters SP, Djukanovic R, Calhoun WJ. Investigative use of bronchoscopy in asthma. Am J Respir Crit Care Med 1998;157:692–697.[Free Full Text]
3. Liu L, Jarjour NN, Busse WW, Kelly EA. Enhanced generation of helper T type 1 and 2 chemokines in allergen-induced asthma. Am J Respir Crit Care Med 2004;169:1118–1124.[Abstract/Free Full Text]

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