Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

NCT ID: NCT01066416

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-12-31

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.

Conditions

Asthma; Chronic Sinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical therapy

Patients undergo surgery 6 months after randomization

Group Type: PLACEBO_COMPARATOR

medical therapy

Intervention Type: OTHER

Subjects will undergo surgery 6 months after randomization

Surgery

Patients undergo surgery at time of randomization

Group Type: EXPERIMENTAL

Endoscopic Sinus Surgery

Intervention Type: PROCEDURE

Interventions

Endoscopic Sinus Surgery

Intervention Type: PROCEDURE

medical therapy

Subjects will undergo surgery 6 months after randomization

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Evanston Hospital

Evanston, Illinois, United States

Countries

United States

Other Identifiers

0001

Identifier Type: -

Identifier Source: org_study_id