DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Tiotropium (Drug); Salmeterol (Drug); Formoterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
Elliot Israel, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital

Summary

We are doing this study to learn how genes affect the way that people, specifically Black people, respond to treatment for asthma. Recent studies suggest that people respond differently to some asthma medications (eg Serevent, Foradil). Some people feel better when they use these inhalers, but others may not, and some people get worse. It seems that this difference shows up more often in Blacks than in Whites, which is why we are looking for Black subjects for this study. In all people, this difference seems to depend on their genes or DNA. This study is comparing the use of long acting asthma medications (Serevent, Foradil) to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat chronic obstructive pulmonary disease (COPD). This study will help to see if this medication is also useful for treating asthma and whether it works better for some people than the current asthma medications.

Clinical Details

Official title: Blacks and Exacerbations on LABA vs. Tiotropium (BELT)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rate of Exacerbations

Secondary outcome:

Patient-reported outcomes (Asthma Quality of Life, Asthma Control, Asthma symptom Utility index, Symptom Free Days)

Spirometry (FEV1)

Rescue Medication Use

Moderate Asthma Deterioration

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Black (self-identified, with at least one biological parent identified as Black) 2. Male and female subjects, ages 18-75 3. Ability to provide informed consent 4. Clinical history consistent with asthma for > 1 year. 5. Ability to perform pulmonary function tests 6. FEV1 > 40% of predicted 7. Receiving inhaled corticosteroids (ICS)/LABA combination therapy, or ICS moderate dose monotherapy and baseline ACQ>1. 25 8. Non-smoker for past year (total lifetime smoking history < 10 pack-years) Exclusion Criteria: 1. Use of greater than the equivalent of 1000 mcg inhaled fluticasone daily 2. Chronic use of oral corticosteroids or Anti IgE for asthma 3. Lung disease other than asthma or diagnosis of vocal cord dysfunction. 4. Significant medical illness (other than asthma) that is not stable. 5. Pregnancy or lactation or an unwillingness to maintain effective birth control. 6. History of a significant exacerbation of asthma or respiratory tract infection in the prior 4 weeks 7. History of life-threatening asthma requiring treatment with intubation and mechanical ventilation within 5 years. 8. Hypo sensitization therapy other than an established maintenance regimen. 9. Use of inhaled anticholinergic therapy (ipratropium, tiotropium) in prior month 10. Known contraindication to inhaled tiotropium e. g. narrow angle glaucoma, history of bladder neck obstruction or significant symptoms related to prostatic hypertrophy. 11. Inability to speak and read English.

Locations and Contacts

Edward Waters College Medical Center (Mayo), Jacksonville, Florida 32209, United States

Urban Family Practice, Marietta, Georgia 30067, United States

Albany Area Primary Healthcare, Inc, Newton, Georgia 39870, United States

Northwestern University, Chicago, Illinois 60611, United States

Wayne State University, Detroit, Michigan 48201, United States

G.A. Carmichael F.H.C., Canton, Mississippi 39046, United States

Swope Parkway Health Center, Kansas City, Missouri 64130, United States

Montefiore Medical Group, Bronx, New York 10462, United States

UNYNET - Jefferson Family Medicine, Buffalo, New York 14215, United States

Carolinas Medical Center - NorthEast (Lovelace), Kannapolis, North Carolina 28081, United States

Cleveland Clinic, Cleveland, Ohio 44195, United States

Family Medicine Occupational Health Center, Shaker Heights, Ohio 44120, United States

BJHCHS - Hardeeville Medical Center, Ridgeland, South Carolina 29936, United States

Additional Information

Starting date: January 2011
Last updated: July 16, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017