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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 26, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
MeiLan Han, University of Michigan

Tracking Information
First Submitted Date  ICMJE August 12, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date July 26, 2019
Actual Study Start Date  ICMJE August 29, 2017
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02867761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative
Official Title  ICMJE RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COPD (Chronic Obstructive Pulmonary Disease)
Intervention  ICMJE
  • Drug: Indacaterol/Glycopyrrolate
    27.5/15.6 mcg active indacaterol/glycopyrrolate
  • Drug: Placebo
    27.5/15.6 mcg placebo
Study Arms  ICMJE
  • Active Comparator: Indacaterol/Glycopyrrolate
    indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily for 12 weeks
    Intervention: Drug: Indacaterol/Glycopyrrolate
  • Placebo Comparator: Placebo
    Placebo 27.5/15.6 mcg inhaled twice daily for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)
580
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: MeiLan Han, MD, MS 734-936-5201 mrking@umich.edu
Contact: Prescott Woodruff, MD, MPH Prescott.Woodruff@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867761
Other Study ID Numbers  ICMJE 1U01HL128952-01( U.S. NIH Grant/Contract )
1U01HL128952 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MeiLan Han, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: MeiLan Han, MD, MS University of Michigan
Principal Investigator: Prescott Woodruff, MD, MPH University of California, San Francisco
PRS Account University of Michigan
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP