Alendronate to Prevent Loss of Bronchoprotection in Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 80
Updated:1/14/2018
Start Date:January 2015
End Date:September 2016

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Proof of Concept Study of Alendronate for Asthma

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.


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
equivalent)

- 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
mg/mL

- 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
We found this trial at
10
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Elliot Israel, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Denver, CO
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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Saint Louis, Missouri 63110
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Saint Louis, MO
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San Francisco, California 94143
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Tucson, AZ
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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