Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

NorthShore University HealthSystem

Status: Terminated

Conditions: Asthma; Chronic Sinusitis

Treatments: Other: medical therapy; Procedure: Endoscopic Sinus Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01066416

0001

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups, including a placebo group

Medical therapy

Placebo Comparator group

Description:

Patients undergo surgery 6 months after randomization

Treatment:

Other: medical therapy

Surgery

Experimental group

Description:

Patients undergo surgery at time of randomization

Treatment:

Procedure: Endoscopic Sinus Surgery