RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative (RETHINC)
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ClinicalTrials.gov Identifier: NCT02867761 |
Recruitment Status :
Recruiting
First Posted : August 16, 2016
Last Update Posted : July 29, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COPD (Chronic Obstructive Pulmonary Disease) | Drug: Indacaterol/Glycopyrrolate Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 580 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative |
Actual Study Start Date : | August 29, 2017 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | July 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Indacaterol/Glycopyrrolate
indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily for 12 weeks
|
Drug: Indacaterol/Glycopyrrolate
27.5/15.6 mcg active indacaterol/glycopyrrolate |
Placebo Comparator: Placebo
Placebo 27.5/15.6 mcg inhaled twice daily for 12 weeks
|
Drug: Placebo
27.5/15.6 mcg placebo |
- Proportion of individuals who experience a 4 unit improvement in SGRQ at 12 weeks and do not meet criteria for treatment failure during the 12 week treatment period [ Time Frame: Baseline and 12 weeks ]Measured by units of improvement in SGRQ scores at Baseline and 12 weeks, as well as review of treatment failure status at 4 weeks and 12 weeks of treatment (treatment failure is defined by an increase in lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilator, corticosteroids or antibiotics).

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867761
Contact: MeiLan Han, MD, MS | 734-936-5201 | mrking@umich.edu | |
Contact: Prescott Woodruff, MD, MPH | Prescott.Woodruff@ucsf.edu |
United States, Alabama | |
Universityof Alabama | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Erica Anderson eanderson@uabmc.edu | |
Principal Investigator: Mark Dransfield | |
United States, California | |
University of California | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Miguel Villarreal MiguelVillarreal@mednet.ucla.edu | |
Principal Investigator: Igor Barjaktarevic, MD, PhD | |
University of California | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Sundos Yassin sundos.yassin@ucsf.edu | |
Principal Investigator: Stephen Lazarus, MD | |
LABIOMED at Harbor-UCLA Medical Center | Recruiting |
Torrance, California, United States, 90502 | |
Contact: Carmen Lopez-Garcia Clopez_garcia@labiomed.org | |
Principal Investigator: William Stringer, MD | |
United States, Illinois | |
University of Illinois | Recruiting |
Chicago, Illinois, United States, 60608 | |
Contact: Lauren Castro lschra3@uic.edu | |
Principal Investigator: Jerry Krishnan, MD, PhD | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60657 | |
Contact: Jenny Hixon j-franzen@northwestern.edu | |
Principal Investigator: Ravi Kalhan | |
United States, Iowa | |
University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Fozia Ghaforr fozia-ghafoor@uiowa.edu | |
Principal Investigator: Alejandro Comellas | |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Cheryl Clare cdaniel9@jhu.edu | |
Principal Investigator: Bob Wise | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Crystal Cutlip ccutlip@umich.edu | |
Principal Investigator: MeiLan Han | |
United States, Minnesota | |
Minneapolis VA Medical Center | Recruiting |
Minneapolis, Minnesota, United States, 55417 | |
Contact: Allison Aase Allison.Aase@va.gov | |
Principal Investigator: Chris Wendt, MD | |
Minnesota Health partners | Recruiting |
Saint Paul, Minnesota, United States, 55130 | |
Contact: Pamela Neuenfeldt, MPH pamela.j.neuenfeldt@healthpartners.com | |
Principal Investigator: Charlene McEvoy | |
United States, New York | |
Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Matthew Marcelino mam2225@med.cornell.edu | |
Principal Investigator: Robert kaner, MD | |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27705 | |
Contact: Erika Coleman erika.coleman@duke.edu | |
Principal Investigator: Neil MacIntyre | |
United States, Pennsylvania | |
Temple University | Recruiting |
Philadelphia, Pennsylvania, United States, 19140 | |
Contact: Dee Fehrle Delores.Fehrle@tuhs.temple.edu | |
Principal Investigator: Gerard Criner, MD | |
University of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Elizabeth Stempkowski stempkowskiem@upmc.edu | |
Principal Investigator: Toru Nyunoya, MD | |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77505 | |
Contact: Brock Melissa mbrock@bcm.edu | |
Principal Investigator: Nicola Hanania, MD, MS | |
United States, Utah | |
University of Utah | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Newsha Sedghi u0984618@utah.edu | |
Principal Investigator: Kanner Richard |
Principal Investigator: | MeiLan Han, MD, MS | University of Michigan | |
Principal Investigator: | Prescott Woodruff, MD, MPH | University of California, San Francisco |
Responsible Party: | MeiLan Han, Professor, Department of Internal Medicine, University of Michigan |
ClinicalTrials.gov Identifier: | NCT02867761 |
Other Study ID Numbers: |
1U01HL128952-01 ( U.S. NIH Grant/Contract ) 1U01HL128952 ( U.S. NIH Grant/Contract ) |
First Posted: | August 16, 2016 Key Record Dates |
Last Update Posted: | July 29, 2020 |
Last Verified: | July 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
COPD Chronic Obstructive Pulmonary Disease Pulmonary Function Tests Current Smoker |
Former Smoker Chronic Obstructive Airway Disease Respiratory Symptoms |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Glycopyrrolate Adjuvants, Anesthesia |
Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |