RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative

Completed · Phase 3 · Has a placebo group

Conditions studied: COPD (Chronic Obstructive Pulmonary Disease)

In brief

The study hypothesis is that symptomatic current and former smokers with spirometric values within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC ≥ 70% predicted will still derive symptomatic benefit from long-acting bronchodilator therapy even though they are excluded from current GOLD guideline recommendations.

Key facts

Study ID

NCT02867761

Run by

University of Michigan

People needed

780

Starts

2017-08-29

Expected to finish

2021-07-07

Last updated by the study team

2023-04-13

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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• Known concomitant lung disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), or clinically significant bronchiectasis.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).

Where it is running

• Universityof Alabama — Birmingham, Alabama, United States
• University of California — Los Angeles, California, United States
• University of California — San Francisco, California, United States
• LABIOMED at Harbor-UCLA Medical Center — Torrance, California, United States
• University of Illinois — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Minneapolis VA Medical Center — Minneapolis, Minnesota, United States
• Minnesota Health partners — Saint Paul, Minnesota, United States
• Cornell University — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Temple University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.