Status:
COMPLETED
Alendronate to Prevent Loss of Bronchoprotection in Asthma
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT02230332
Start Date
January 1 2015
End Date
September 1 2016
Last Update
January 12 2018
Active Locations (10)
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1
University of Arizona College of Medicine
Tucson, Arizona, United States, 85724
2
University of California - San Francisco
San Francisco, California, United States, 94143
3
National Jewish Health
Denver, Colorado, United States, 80206
4
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611