Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

NCT01066416 | Terminated DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Asthma Control Score

Study Arms (2)

Medical therapy

PLACEBO COMPARATOR

Patients undergo surgery 6 months after randomization

Other: medical therapy

Surgery

EXPERIMENTAL

Patients undergo surgery at time of randomization

Procedure: Endoscopic Sinus Surgery

Interventions

Endoscopic Sinus Surgery PROCEDURE

Surgery

medical therapy OTHER

Subjects will undergo surgery 6 months after randomization

Medical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Women need one of the following: negative pregnancy test or suitable birth control or post-menopausal status
• 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:
• 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).
• 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.

You may not qualify if:

• Current smokers or those with at least a 10 pack-year smoking history
• 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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: July 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (1)