This article has been corrected. See "ERRATUM: Author's Name Correction. The safety and efficacy of recombinant fibroblast growth factor 2 in human asthmatics: A pilot study" in Volume 2 on page 314.
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Abstract
Purpose
Fibroblast growth factor 2 (FGF2) has been shown to inhibit airway inflammation, mucus production, and airway hyperresponsiveness in mouse model of asthma. The aim of this study was to evaluate the safety and efficacy of inhaled recombinant FGF2 in asthmatic patients.
Methods
Eight asthmatics were eligible for the study. All patients were admitted to a hospital, and recombinant FGF2 was administered using a nebulizer at a concentration of 4.5 ng/mL three times a day for one week. Pulmonary function test, methacholine bronchial provocation test, induced sputum analysis, asthma control test (ACT), and asthma quality of life questionnaire (AQLQ) were performed at the beginning of wash-out period, before and after the treatment, and at the end of study. And all these parameters were compared before and after FGF2 treatment.
Results
There were no serious adverse events associated with recombinant FGF2 during five-week study period. Daytime and nocturnal symptoms improved after the treatment (P=0.028 and P=0.012, respectively). AQLQ and ACT also improved after the treatment (P=0.017 and P=0.011, respectively). However, lung function, airway hyperresponsiveness, and airway inflammation showed no significant difference before and after the treatment.
Figures and Tables
Fig. 1
The change of nocturnal symptom score before and after the treatment of recombinant fibroblast growth factor 2. *P=0.028.
Fig. 2
The change of daytime symptom score before and after the treatment of fibroblast growth factor 2. *P=0.012.
Fig. 3
The change of asthma quality of life questionnaire score before and after the treatment of recombinant fibroblast growth factor 2. *P=0.017.
Fig. 4
The change of asthma control test score before and after the treatment of recombinant fibroblast growth factor 2. *P=0.011.
Fig. 5
The change of forced expiratory volume in 1 second (% predicted) before and after the treatment of recombinant fibroblast growth factor 2.
Fig. 6
The change of PC20 (mg/mL) before and after the treatment of recombinant fibroblast growth factor 2. PC20, provocative concentration casuing 20% fall in forced expiratory volume in 1 second.
Fig. 7
The change of cytokine levels in induced sputum analysis before and after the treatment of recombinant fibroblast growth factor 2. IL, interleukin; IFN, interferon.
Fig. 8
The change of eosinophil proportion in induced sputum analysis before and after the treatment of recombinant fibroblast growth factor 2.
Table 2
The adverse events during and after treatment with inhaled recombinant fibroblast growth factor 2
URI, upper respiratory tract infection.
*Severity: 1, mild; 2, moderate; 3, severe; 4, not applicable. †Causal relationship: 1, no association; 2, less association; 3, high association; 4, definite association. ‡Management: 0, no specific management; 1, temporary stop or change of dose; 2, stop treatment; 3, administration of therapeutic medications; 4, nonpharmaceutical treatment; 5, extension of hospital stay.
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