DrugLib.com — Drug Information Portal

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

Alendronate to Prevent Loss of Bronchoprotection in Asthma

Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Alendronate (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Milton S. Hershey Medical Center

Official(s) and/or principal investigator(s):
Juan Carlos Cardet, MD, Study Director, Affiliation: Brigham and Women's Hospital

Overall contact:
David T Mauger, PhD, Phone: 717.531.7178, Email: dmauger@psu.edu


Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against stimuli that produce bronchoconstriction. The combination of long-acting beta agonists (LABA) and inhaled corticosteroids (ICS) has become the most commonly used asthma controller medication class in the United States, but unfortunately, even when LABAs are added to ICS and used regularly, 58-81% of patients with asthma fail to achieve total control. Regular use of beta-agonists, both short and long-acting, reduces the ability of these agents to protect against the airway narrowing that occurs in asthma in response to bronchoconstrictor stimuli. We refer to this reduced effect as loss of bronchoprotection. In this proof of concept trial we aim to determine if alendronate, which diminishes beta-2 adrenergic receptor internalization, can reduce the loss of bronchoprotection that occurs with regular use of LABAs, even when used in combination with ICS.

Clinical Details

Official title: Proof of Concept Study of Alendronate for Asthma

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Salmeterol Protected Methacholine Challenge PC20

Secondary outcome:

Peripheral blood mononuclear cell ADRB2 cell surface density

Peripheral blood mononuclear cell ADRB2 signaling function as measured by beta-2 adrenergic receptor agonist-induced cAMP production


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria:

- Clinical history consistent with moderate asthma for >1 year

- Asthma is controlled with ICS, with an FP dose ≤ 1000mcg/day and >100mcg/day (or


- Able to perform reproducible spirometry according to ATS criteria

- Baseline FEV1 ≥ 50% of predicted and ≥1L.

- If FEV1 <80%, a minimum 12% increase in FEV1 post-bronchodilator or a MCh PC20 ≤ 8


- If FEV1 ≥80%, a MCh PC20 ≤ 8 mg/mL

- Salmeterol protected MCh ≤ 16 mg/mL

Exclusion Criteria:

- Uncontrolled asthma, as suggested by an ACT score <18 while on high-dose ICS (FP

daily dose >500mcg or equivalent)

- Non-ICS controller medication or LABA use within 4 weeks of study entry.

- Contraindications to use of bisphosphonates: history of intolerance to

bisphosphonates, history of esophageal ulcers, history of hematemesis, uncontrolled gastro-esophageal reflux disease, inability to stay erect for 30 minutes after oral drug, history of osteonecrosis of the jaw, dental extraction or root canal in prior 8 weeks, or anticipated during the study

- Calculated GFR of less than 35 mL/min

- History of smoking (cigarettes, cigars, pipes, marijuana or any other substances)

within the past 1 year, or > 10 pack-years total if ≥ 18 years of age

- Systemic corticosteroid treatment for any condition within 4 weeks of enrollment at

Visit 1, history of significant asthma exacerbation requiring systemic corticosteroids within 4 weeks of Visit 1 or more than five courses of systemic corticosteroids in the past year, history of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years

- History of a respiratory tract infection within 4 weeks of Visit 1

- Receiving hyposensitization therapy other than an established maintenance regimen

defined as a continuous regimen for ≥ 3 months prior to enrollment

Locations and Contacts

David T Mauger, PhD, Phone: 717.531.7178, Email: dmauger@psu.edu

University of Arizona College of Medicine, Tucson, Arizona 85724, United States; Recruiting

University of California - San Francisco, San Francisco, California 94143, United States; Recruiting

National Jewish Health, Denver, Colorado 80206, United States; Recruiting

Northwestern Memorial Hospital, Chicago, Illinois 60611, United States; Recruiting

University of Chicago, Chicago, Illinois 60637, United States; Recruiting

University of Illinois at Chicago, Chicago, Illinois 60612, United States; Recruiting

Brigham & Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Elliot Israel, MD, Principal Investigator

Washington University, St. Louis, Missouri 63110, United States; Recruiting

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting

University of Wisconsin, Madison, Wisconsin 53972, United States; Recruiting

Additional Information

AsthmaNet home page

Starting date: January 2015
Last updated: January 9, 2015

Page last updated: August 20, 2015

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

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