ANCHOR asthma clinical trial
Principal Investigator: Charlene McEvoy, MD, MPH
Study sponsor: AstraZeneca Pharmaceuticals LP
Location: Enrolled participants do not need to travel.
Purpose of study: The ANCHOR asthma clinical trial is being done by AstraZeneca to assess how well AIRSUPRA reduces severe asthma attacks in adults. AIRSUPRA is an FDA approved rescue inhaler that combines two common asthma medicines (albuterol and budesonide) into a single inhaler that will help treat symptoms and help prevent asthma attacks. Albuterol helps to relax the smooth muscles of the airways, causing the airways to widen, leading to easier breathing. Budesonide helps to decrease inflammation in the lungs.
Participants will use the AIRSUPRA inhaler for 12 months, which will be provided at no cost. Participants will also be asked to complete surveys online every three months and answer questions about your experience with the inhaler over the phone every three months.
If you’re interested and would like to learn more and see if you are eligible to participate, follow the link below.
Click here to learn more about the ANCHOR asthma clinical trial
Inclusion Criteria:
You may be eligible to participate if you meet the following criteria:
– have an asthma diagnosis and prescription for asthma is an albuterol-only OR levalbuterol-only inhaler
– had at least one healthcare visit related to asthma within the last 12 months.
– had at least one asthma attack or used an oral steroid for asthma within the last 12 months.
– are not currently pregnant, breastfeeding, or planning to become pregnant with 12 months.
– do not have major respiratory diagnoses in the past 12 months like COPD, cystic fibrosis, etc.
– have not had cancer (not including skin cancer) that was untreated, still being treated, or not in remission in the past 12 months.
– do not use oral corticosteroids like prednisone daily or every other day for more than 14 days in the past 3 months.
Study Contact:
(952) 967-6910
AnchorStudy@HealthPartners.com
Home Based Pulmonary Rehabilitation for COPD
Principal Investigator: Dr. Charlene McEvoy
Study Sponsor: Mayo Clinic, in Collaboration with National Heart, Lung, and Blood Institute (NHLBI)
Location: Regions Hospital
Purpose of Study: While pulmonary rehabilitation provides benefits to people with COPD, only 1.5% have access to pulmonary rehabilitation each year. The main barriers are related to travel and transportation. This study will evaluate the effect of a home-based rehabilitation system on quality of life and steps. The system allows for monitoring by a health care system. A health coach will review the data and provide coaching to facilitate behavioral change and self-efficacy
Inclusion Criteria:
Clinical diagnosis of COPD,
Age ≥40 years
Current or previous smoker (≥10 packs per year)
Confidence in using the proposed PR system
English or Spanish language fluency
Exclusion Criteria:
Unable or unwilling to do Rehabilitation due to physical conditions
Study Contact:
Allison Spradley, LPN, Research Coordinator
(952) 883-7155
REdefining THerapy In Early COPD (RETHINC)
Recruitment paused due to COVID-19
Principal Investigator: Charlene McEvoy, MD
Study Sponsors:
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Location: Regions Hospital
Phase of Study: Phase 3
Purpose of study: The purpose of this study is to evaluate a drug (indacaterol/glycopyrrolate.) that may help improve breathing in people who do not meet the current criteria for COPD but have respiratory symptoms (such as coughing and shortness of breath). Indacaterol/glycopyrrolate is an inhaled medication that is a FDA approved medication for people who have Chronic Obstructive Pulmonary Disease (COPD). In this study, some people will receive the investigational drug (indacaterol/glycopyrrolate) and some people will receive a placebo. A placebo looks like the study drug but does not contain any drug. Researchers use a placebo to see if indacaterol/glycopyrrolate works better than taking placebo.
Inclusion Criteria:
-Subject must be able to understand and provide informed consent
-Age 40-80
-≥10 pack-year smoking history
-Post-bronchodilator FEV1/FVC ratio ≥0.70
-Baseline CAT≥10
Exclusion Criteria:
-Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
-Subject is pregnant, breast-feeding, or plans to become pregnant.
-Active pulmonary infection or prior pulmonary infection where antibiotic and/or steroid treatment was completed ≤4 weeks prior to enrollment.
-Post-BD FVC < 70% predicted
-A primary diagnosis of asthma established by each study investigator based on ATS/ERS criteria as previously implemented in the MACRO clinical trial.
-Known concomitant lung disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), or clinically significant bronchiectasis.
-History (or family history) of long QT syndrome.
-History of paroxysmal (intermittent) atrial fibrillation will be considered an exclusion. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, heart rate at enrollment must be < 100/min.
-Patients with BMI < 15 or more than 40 kg/m2.
-Patients with diabetes Type I or uncontrolled diabetes Type II.
-Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) significant renal disease, psychiatric disease, gastrointestinal disease, unstable ischemic heart disease, arrhythmia (excluding chronic stable atrial fibrillation), uncontrolled hypertension or any other condition which in the opinion of investigator might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
-Patients with any history of lung cancer.
-Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or severe renal impairment or urinary retention. Benign Prostatic Hyperplasia (BPH) patients who are stable on treatment can be considered.
-Any other past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant’s ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
-Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar chemical classification, including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
-Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.
-Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer.
-Patients receiving any protocol-specified prohibited medications..
-Patients receiving any protocol-specified prohibited COPD related medications (will be required to undergo a required washout period prior to enrollment).
Study Contact:
Cheryl Sasse
(952) 967-5169
