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Completed

NCT Number: NCT02024659

Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Nasal Polyps

This randomized, double-blind, placebo-controlled clinical trial enrolled subjects with eosinophilic CRSwNP. Subjects were randomized to receive either budesonide inhalation suspension or placebo for 14 days. Visual analogue scales (VAS）of nasal symptoms, endoscopic polyp scores and morning serum cortical levels were assessed pre- and post-treatment. Polyp samples were evaluated for inflammatory cytokines, matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) by immunoassay; collagen by histochemistry; and frequencies of different inflammatory T cell infiltration by flow cytometry. this study is undertaken to evaluate the efficacy of short-term prescription of budesonide inhalation suspension via transnasal nebulization by clinical and immunologic assessments. As outcome parameters for remodeling, differences in the expression of collagen and albumin were investigated before and after budesonide treatment. Meanwhile, TGF-β, MMPs and TIMPs expression differences in nasal polyps were investigated to explore underlying mechanisms of tissue reconstitution.

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Key information

Conditions

Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of chronic rhinosinusitis was made on the basis of symptoms of rhinosinusitis for at least 12 weeks, confirmed by abnormalities in all sinuses on computed tomography scan.
  • Bilateral nasal polyps were present.
  • CRSwNP was defined as eosinophilic when percent of tissue eosinophils exceeded 10% of total infiltrating cells.
  • All patients had taken no steroids or antibiotics for at least 4 weeks before sample collection.

Exclusion criteria

  • cystic fibrosis
  • pregnancy
  • serious or unstable concurrent disease
  • psychological disorder.

Treatment and study plan

Budesonide

Drug

Patients receive 1mg/2ml budesonide twice daily via transnasal nebulization for 14 days.

Placebo

Other

patients receive placebo (saline solution) 2ml twice daily for 14 days.

Primary outcomes

  1. reduction of nasal polyp size

    Time frame: from baseline to two weeks

    endoscopic polyp scores are assessed pre- and post-treatment.

  2. patients' assessment of symptoms improvement

    Time frame: from baseline to two weeks

    Four major symptoms, including nasal obstruction, discharge, loss of smell, headache/ facial pain, and TNSS were assessed by the patient pre- and post-treatment

Secondary outcomes

  1. immunologic effect of budesonide transnasal nebulization in CRSwNP

    Time frame: from baseline to 2 weeks

    Polyp samples were evaluated for inflammatory cytokines, mediators and cellular infiltration pre- and post-treatment.

  2. remodeling effect of budesonide transnasal nebulization in CRSwNP

    Time frame: from baseline to 2 weeks

    Albumin, collagen,TGF-beta, matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) were measured in tissue homogenate at baseline and after 2-week treatment

Other outcomes

  1. safety of budesonide via transnasal nebulization in nasal polyps

    Time frame: from baseline to 2 weeks

    Morning corticol level is measured pre- and post-treatment. The incidence and severity of adverse events are recorded during treatment.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Important dates

Study start
2010
Primary completion
2011
Study completion
2014
First posted
Dec 31, 2013
Registry last updated
Oct 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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