Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

Not Applicable

Terminated

• Conditions: Chronic Sinusitis; Asthma
• Interventions: Other: medical therapy; Procedure: Endoscopic Sinus Surgery

• Registration Number: NCT01066416
• Lead Sponsor: NorthShore University HealthSystem

Brief Summary

It is unknown whether surgical treatment of chronic sinusitis improves asthma control in patients with poorly controlled asthma. This is a randomized trial of surgical plus medical sinus therapy versus medical therapy alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-19
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Inclusion criteria: General

  1. 18 years of age or older
  2. Women need one of the following: negative pregnancy test or suitable birth control or post-menopausal status
  3. Informed consent and ability to comply with study procedures
  4. Patients must meet inclusion criteria for both asthma and sinus disease.

Inclusion criteria: Asthma

In order to qualify for the 6 week run-in, patients must have poorly controlled asthma as defined by the following criteria:

1. Diagnosis of asthma confirmed either by demonstrating a positive methacholine challenge test (defined as a decrease in FEV1 by at least 20%, following administration of 8mg or less of inhaled methacholine) or a positive bronchodilator response (defined as a change from base line of >12% and at least 200ml in either FEV1 or FVC, following administration of a short-acting, inhaled bronchodilator).

2. Either:

   • Asthma Control Questionnaire score > 1.5 or
   • Use of inhaled rescue ß-agonist >/= 16 puffs per week (excluding use as a pre-medication for exercise; 1 nebulizer treatment = 2 puffs of inhaler) at any time during the past month or
   • >1 hospitalization or unscheduled MD visit in the past 6 months for asthma symptoms or
   • >1 course of oral steroid use in past 6 months or
   • > 2 weeks of systemic steroids in last 6 months.

Exclusion Criteria

1. Current smokers or those with at least a 10 pack-year smoking history
2. Presence of any concurrent diseases that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical therapy	medical therapy	Patients undergo surgery 6 months after randomization
Surgery	Endoscopic Sinus Surgery	Patients undergo surgery at time of randomization

Primary Outcome Measures

Name	Time	Method
Asthma Control Score

Trial Locations

Locations (1)

Evanston Hospital; 🇺🇸 Evanston, Illinois, United States