Bariatric and Obstructive Lung Disease Study II

Obesity Clinical Trial

— BOLD II  

Official title:

Effects of Obesity on Airway Caliber and Airway Smooth Muscle Tone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01127399
• Other study ID #: NA_00027264
• Secondary ID: K23HL097081
• Status: Terminated
• Phase: N/A
• First received: May 19, 2010
• Last updated: January 31, 2018
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The prevalence of obesity and asthma has significantly increased over the past two decades. The purpose of this study is to try and understand the mechanism by which obesity leads to airway hyperresponsiveness (AHR), one of the defining features of asthma. This research is being done to determine how weight or body size affects airway size and airway smooth muscle (ASM) tone and function. The goal of the study will be to look at if and how, weight might affect lung functioning.

The investigators hypothesize that low lung volumes in obesity lead to AHR by reducing airway caliber causing increased ASM tone with impairment in deep inspiration (DI) response similar to what is seen in asthma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• BMI over 35 kg/m2 (Bariatric) or BMI between 25 and 28 kg/m2 (Control)

• Physician diagnosis of asthma and on active asthma medication (if asthmatic)

Exclusion Criteria:

• Weight greater than 450 lbs

• Unstable cardiovascular disease

• Uncontrolled hypertension

• Renal failure on dialysis

• Cirrhosis

• Pregnant or lactating

• Bleeding disorders or Coumadin use

• Recent hospitalization for asthma in the past 3 months

• Active smoking or more than 10 pack year smoking history

Related Conditions & MeSH terms

• Asthma
• Obesity

Locations

Country	Name	City	State
United States	The Johns Hopkins University, The Johns Hopkins Bayview Medical Campus	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States,