The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Robert Brown, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00994604
First received: October 13, 2009
Last updated: May 30, 2014
Last verified: September 2012
  Purpose

The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.


Condition Intervention
Asthma
COPD
Drug: broccoli sprout extract

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The primary outcome is the change in bronchodilation and bronchoprotection after broccoli sprout extract [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in biomarkers, Change in inflammatory mediators, Change in airway distensibility, Change in parenchyma [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2009
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: broccoli sprout extract Drug: broccoli sprout extract
consumption of broccoli sprout extract for 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • asthma
  • COPD

Exclusion Criteria:

  • currently on chronic oral steroid medications
  • current respiratory symptoms
  • pregnant
  • FEV1 less than 40% predicted at baseline
  • extreme degrees of bronchial hyperreactivity
  • recent respiratory infection (<3 weeks)
  • unstable symptoms in the prior month
  • a history of intubation for respiratory symptoms within the past year
  • any history of cardiac disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994604

Locations
United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Robert Brown, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00994604     History of Changes
Other Study ID Numbers: RB-001
Study First Received: October 13, 2009
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014