Allergy Asthma Respir Dis.  2014 Jul;2(3):200-207. 10.4168/aard.2014.2.3.200.

The safety and efficacy of recombinant fibroblast growth factor 2 in human asthmatics: A pilot study

• Kim YS
• Jang YH
• Jeon JH
• Seo JH
• Kang SH
• Jee YK

• KMID: 2262520
• DOI: http://doi.org/10.4168/aard.2014.2.3.200

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.
CONCLUSION
Inhaled recombinant FGF2 was safely used to eight asthmatics without any serious adverse events, and improved daytime and nocturnal symptoms, and quality of life in adult asthmatics. FGF2 may be a potential drug in the treatment of asthma.

Keyword

Bronchial asthma; Fibroblast growth factor 2; Airway remodeling

MeSH Terms

Adult
Airway Remodeling
Animals
Asthma
Bronchial Provocation Tests
Fibroblast Growth Factor 2*
Humans
Inflammation
Lung
Methacholine Chloride
Mice
Mucus
Nebulizers and Vaporizers
Pilot Projects*
Quality of Life
Respiratory Function Tests
Sputum
Surveys and Questionnaires
Fibroblast Growth Factor 2
Methacholine Chloride

Figure

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  Fig. 1 The change of nocturnal symptom score before and after the treatment of recombinant fibroblast growth factor 2. *P=0.028.

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  Fig. 2 The change of daytime symptom score before and after the treatment of fibroblast growth factor 2. *P=0.012.

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  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.

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  Fig. 4 The change of asthma control test score before and after the treatment of recombinant fibroblast growth factor 2. *P=0.011.

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  Fig. 5 The change of forced expiratory volume in 1 second (% predicted) before and after the treatment of recombinant fibroblast growth factor 2.

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  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.

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  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.

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  Fig. 8 The change of eosinophil proportion in induced sputum analysis before and after the treatment of recombinant fibroblast growth factor 2.

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