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Effect of topical application of human basic fibroblast growth factor on epithelialization and recovery of ciliary function in patients with chronic rhinosinusitis

Effect of topical application of human basic fibroblast growth factor on epithelialization and recovery of ciliary function in patients with chronic rhinosinusitis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032203
Enrollment
Unknown
Registered
2020-04-23
Start date
2019-04-01
Completion date
Unknown
Last updated
2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic rhinosinusitis

Interventions

nasal spray group:Recombinant human basic fibroblast growth factor 70 000 IU was added to the bilateral surgical cavity filler after FESS, and again at the 14 days
Control group:The bilateral nasal cavity of patients after FESS was filled routinely and treated postoperatively
nasal drip group:Recombinant human basic fibroblast growth factor 70 000 IU was added to the bilateral surgical cavity filler after FESS, and again at the 14 days

Sponsors

The First Affliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A total of 60 patients with bilateral chronic sinusitis were selected (the diagnosis of chronic sinusitis was based on EPOS 2012 and CPOS diagnostic criteria). The difference of CT score and endoscopy score between the two sides of patients with chronic sinusitis was not more than 1 point, the total score was not more than 2 points; the age was more than 8 years old and less than 75 years old. FEV1 > 60% predicted value can tolerate general anesthesia operation. Subjects must volunteer to participate in the study and comply with the research requirements, agree to the operation, understand and follow-up plan, and correctly record scale scores, medication times, concomitant medication and adverse events.

Exclusion criteria

Exclusion criteria: 1. There are the following diseases: cystic fibrosis, congenital ciliary dyskinesia, nasal tumors or other obstructive injuries, large area of nasal bone hyperplasia, large area of nasal polyps (sinus polyps), invasive or non-invasive fungal sinusitis; 2. There are serious metabolic, cardiovascular, immune, neurological, blood, digestive, cerebrovascular or respiratory diseases in clinic, or any disease that the researchers consider to interfere with the evaluation of the results of the study or affect the safety of the subjects; 3. Currently participating in other clinical studies or other clinical researchers within 30 days, or staff directly involved in the study; 4. Psychiatric history, antagonistic personality, bad motivation, suspicion or other emotional or intellectual problems may affect the effectiveness of informed participation in the study; 5. Pregnant or lactating women; 6. Drug allergy to basic fibroblast growth factor (rh-bFGF), glucocorticoid and mucosal discharge.

Design outcomes

Primary

MeasureTime frame
nasal symptom VAS score;Sinusitis Quality of Life Scale(SNOT-20);Sinus CT Lund-Mackey score;nasal endoscopy Lund-Kennedy score;Epithelial thickness of nasal mucosa;Number of cilia in nasal mucosa epithelium;Frequency of epithelial oscillation of nasal mucosa;

Countries

China

Contacts

Public ContactJian-Bo Shi

The First Affliated Hospital of Sun Yat-Sen University

tsjbent@163.com+86 13808884437

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026