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



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 80
Updated:9/27/2018
Start Date:August 29, 2017
End Date:July 2019
Contact:MeiLan Han, MD, MS
Email:mrking@umich.edu
Phone:734-936-5201

Use our guide to learn which trials are right for you!

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.

RETHINC is a 12-week multicenter, randomized, double-blind, placebo-controlled,
parallel-group study to assess the efficacy and safety of indacaterol/glycopyrrolate
27.5/15.6 mcg inhaled twice daily in symptomatic current and former smokers with respiratory
symptoms despite preserved spirometry as defined by CAT ≥ 10 and post-bronchodilator FEV1/FVC
ratio ≥0.70, respectively.

Inclusion Criteria:

1. Subject must be able to understand and provide informed consent

2. Age 40-80

3. ≥10 pack-year smoking history

4. Post-bronchodilator FEV1/FVC ratio ≥0.70

5. Baseline CAT≥10

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or comply
with study protocol.

2. Subject is pregnant, breast-feeding, or plans to become pregnant.

3. Active pulmonary infection or prior pulmonary infection where antibiotic and/or
steroid treatment was completed ≤4 weeks prior to enrollment.

4. Post-BD FVC < 70% predicted

5. A primary diagnosis of asthma established by each study investigator based on ATS/ERS
criteria as previously implemented in the MACRO clinical trial.

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x-ray to be no longer active), or clinically significant bronchiectasis.

7. History (or family history) of long QT syndrome.

8. 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.

9. Patients with BMI < 15 or more than 40 kg/m2.

10. Patients with diabetes Type I or uncontrolled diabetes Type II.

11. 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.

12. Patients with any history of lung cancer.

13. 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.

14. 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.

15. 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.

16. Patients unable to successfully use a dry powder inhaler device or perform spirometry
measurements.

17. Use of other investigational drugs at the time of enrollment or within 30 days or 5
half-lives of enrollment, whichever is longer.

18. Patients receiving any protocol-specified prohibited medications..

19. Patients receiving any protocol-specified prohibited COPD related medications (will be
required to undergo a required washout period prior to enrollment).
We found this trial at
17
sites
640 Jackson Street
Saint Paul, Minnesota 55101
Principal Investigator: Charlene McEvoy
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Bob Wise
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Neil MacIntyre
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Nicola Hanania, MD, MS
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Alejandro Comellas
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Toru Nyunoya, MD
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Kanner Richard
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: MeiLan Han
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Birmingham, Alabama 35294
Principal Investigator: Mark Dransfield
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Birmingham, AL
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Principal Investigator: Jerry Krishnan, MD, PhD
Univ of Illinois A major research university in the heart of one of the world's...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Ravi Kalhan
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Los Angeles, California 90095
Principal Investigator: Igor Barjaktarevic, MD, PhD
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Minneapolis, Minnesota 55417
Principal Investigator: Chris Wendt, MD
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New York, New York 10021
Principal Investigator: Robert kaner, MD
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Gerard Criner, MD
Temple University Temple University is many things to many people. A place to pursue life's...
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San Francisco, California 94143
Principal Investigator: Stephen Lazarus, MD
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Torrance, California 90502
Principal Investigator: William Stringer, MD
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