Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Milton S. Hershey Medical Center
With
National Heart, Lung, and Blood Institute (NHLBI)
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Alendronate to Prevent Loss of Bronchoprotection in Asthma
