COPD (Chronic Obstructive Pulmonary Disease)Phase 3RETHINCNCT02867761
RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative
A Phase 3 study testing Indacaterol/Glycopyrrolate in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Michigan at 16 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Indacaterol/Glycopyrrolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 780 participants
- Where
- 16 sitesUnited States
- Study dates
- 29 Aug 2017to 7 Jul 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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- Known concomitant lung disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), or clinically significant bronchiectasis.
Show all 19Show fewer
- 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).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21224
Universityof Alabama
Birmingham, Alabama, 35294
University of Illinois
Chicago, Illinois, 60608
Northwestern University
Chicago, Illinois, 60657
Duke University
Durham, North Carolina, 27705
University of Iowa
Iowa City, Iowa, 52242
University of California
Los Angeles, California, 90095
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
Cornell University
New York, New York, 10021
Temple University
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Minnesota Health partners
Saint Paul, Minnesota, 55130
University of Utah
Salt Lake City, Utah, 84132
University of California
San Francisco, California, 94143
LABIOMED at Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
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.
Read the 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.
- Being tested
- Indacaterol/Glycopyrrolate, Placebo
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Pulmonary Function Tests, Current Smoker, Former Smoker, Chronic Obstructive Airway Disease, Respiratory Symptoms
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking Cessation, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indacaterol/GlycopyrrolateDrug
27.5/15.6 mcg active indacaterol/glycopyrrolate
PlaceboDrug
27.5/15.6 mcg placebo
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol/Glycopyrrolate | Active comparator | indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily for 12 weeks Receives: Drug: Indacaterol/Glycopyrrolate |
| Placebo | Placebo comparator | Placebo 27.5/15.6 mcg inhaled twice daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (Percentage) of Individuals Who Experience a 4 Unit Improvement in St. George's Respiratory Questionnaire (SGRQ) at 12 Weeks and do Not Meet Criteria for Treatment Failure During the 12 Week Treatment Period
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).
A 4 unit change is the minimum clinically important difference. SGRQ has a 0 - 100 score; 0 as low symptoms (feeling better) and 100 as high symptoms (feeling worse).
Measured: Baseline and 12 weeks
Secondary outcomes (13)
Proportion of Individuals With a 2 Unit Improvement in CAT Without Treatment Failure
Proportion of individuals with a 2 unit improvement in CAT without treatment failure
Measured: 12 weeks
Proportion of Individuals With a 1 Unit Improvement in the BDI/TDI Without Treatment Failure
Proportion of individuals with a 1 unit improvement in the BDI/TDI without treatment failure
Measured: 12 weeks
Proportion of Individuals With Both a 4 Unit Improvement in SGRQ and a 1 Unit Improvement in BDI/TDI Without Treatment Failure
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).
Measured: 12 weeks
Mean Change in St. George's Respiratory Questionnaire (SGRQ)
Value at 12 Weeks Minus Baseline. SGRQ has a 0 - 100 score; 0 as low symptoms (feeling better) and 100 as high symptoms (feeling worse).
Measured: Baseline, 12 weeks
Mean Change in COPD Assessment Test (CAT)
Value at 12 Weeks Minus Baseline. 0 - 40; 0 as low symptoms (feeling better) and 40 as high symptoms (feeling worse).
Measured: Baseline, 12 weeks
Mean Change in Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI)
Value at 12 Weeks Minus Baseline.
Measured: 12 Weeks
Area Under the Curve (AUC) 0-3 Hours for FEV1
FEV1 AUC0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in liters.
Measured: At 12 weeks, FEV1 is measured at 1-hour intervals for 3 hours
Change From Baseline in Trough Forced Expiratory Volume Per 1 Second (FEV1) - Absolute Value
Trough FEV1 at 12 week minus trough FEV1 at baseline.
Measured: Baseline to 12 Weeks
Change From Baseline in 12 Hour Trough Inspiratory Capacity - Absolute Value
Change from baseline in 12 hour trough inspiratory capacity - absolute value
Measured: Baseline
Symptoms and Rescue Medication Use Based on Daily Diary
Percentage of days with symptoms (shortness of breath, chest tightness, wheezing, cough, or sputum) or use of albuterol
Measured: During study follow-up (Baseline to 12 weeks)
Treatment Failure Defined by Increase in Lower Respiratory Symptoms Necessitating Treatment With Active, Long-acting Inhaled Bronchodilator, Corticosteroids or Antibiotics
Treatment failure defined by increase in lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilator, corticosteroids or antibiotics
Measured: During study follow-up (baseline to 12 Weeks)
Change From Baseline in Trough FEV1 - % Predicted
Trough FEV1 at 12 week minus trough FEV1 at baseline.
Measured: Baseline to 12 Weeks
Change in FEF25-75%
FEF25-75%-Forced expiratory flow over the middle one half of the FVC; the average flow from the point at which 25 percent of the FVC has been exhaled to the point at which 75 percent of the FVC has been exhaled.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start29 Aug 2017
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, MeiLan Han, University of Michigan
- Investigators
- MeiLan Han, MD, MS, Principal investigator, University of MichiganPrescott Woodruff, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867761
- Sponsor's protocol ID
- 1U01HL128952-01
- Other IDs
- 1U01HL128952
- Acronym
- RETHINC
- Status last verified
- Apr 2023
- First submitted
- 12 Aug 2016
- Last updated
- 13 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Han MK, Ye W, Wang D, White E, Arjomandi M, Barjaktarevic IZ, Brown SA, Buhr RG, Comellas AP, Cooper CB, Criner GJ, Dransfield MT, Drescher F, Folz RJ, Hansel NN, Kalhan R, Kaner RJ, Kanner RE, Krishnan JA, Lazarus SC, Maddipati V, Martinez FJ, Mathews A, Meldrum C, McEvoy C, Nyunoya T, Rogers L, Stringer WW, Wendt CH, Wise RA, Wisniewski SR, Sciurba FC, Woodruff PG; RETHINC Study Group. Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function. N Engl J Med. 2022 Sep 29;387(13):1173-1184. doi: 10.1056/NEJMoa2204752. Epub 2022 Sep 4.
PubMed 36066078
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative
- ClinicalTrials.gov ID
- NCT02867761
- Acronym / sponsor ID
- RETHINC / 1U01HL128952-01
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Pulmonary Function Tests, Current Smoker, Former Smoker, Chronic Obstructive Airway Disease, Respiratory Symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Posted 30 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indacaterol/Glycopyrrolate | Active comparator | Drug: Indacaterol/Glycopyrrolateindacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 27.5/15.6 mcg inhaled twice daily for 12 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indacaterol/Glycopyrrolate27.5/15.6 mcg active indacaterol/glycopyrrolate | Drug | Indacaterol/Glycopyrrolate |
| Placebo27.5/15.6 mcg placebo | Drug | Placebo |
Primary outcome
Proportion (Percentage) of Individuals Who Experience a 4 Unit Improvement in St. George's Respiratory Questionnaire (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). A 4 unit change is the minimum clinically important difference. SGRQ has a 0 - 100 score; 0 as low symptoms (feeling better) and 100 as high symptoms (feeling worse).
13 secondary outcomes
Proportion of Individuals With a 2 Unit Improvement in CAT Without Treatment Failure
Time frame: 12 weeks
Proportion of Individuals With a 1 Unit Improvement in the BDI/TDI Without Treatment Failure
Time frame: 12 weeks
Proportion of Individuals With Both a 4 Unit Improvement in SGRQ and a 1 Unit Improvement in BDI/TDI Without Treatment Failure
Time frame: 12 weeks
Mean Change in St. George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline, 12 weeks
Mean Change in COPD Assessment Test (CAT)
Time frame: Baseline, 12 weeks
Mean Change in Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI)
Time frame: 12 Weeks
Area Under the Curve (AUC) 0-3 Hours for FEV1
Time frame: At 12 weeks, FEV1 is measured at 1-hour intervals for 3 hours
Change From Baseline in Trough Forced Expiratory Volume Per 1 Second (FEV1) - Absolute Value
Time frame: Baseline to 12 Weeks
Change From Baseline in 12 Hour Trough Inspiratory Capacity - Absolute Value
Time frame: Baseline
Symptoms and Rescue Medication Use Based on Daily Diary
Time frame: During study follow-up (Baseline to 12 weeks)
Treatment Failure Defined by Increase in Lower Respiratory Symptoms Necessitating Treatment With Active, Long-acting Inhaled Bronchodilator, Corticosteroids or Antibiotics
Time frame: During study follow-up (baseline to 12 Weeks)
Change From Baseline in Trough FEV1 - % Predicted
Time frame: Baseline to 12 Weeks
Change in FEF25-75%
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36066078Han MK, Ye W, Wang D, White E, Arjomandi M, Barjaktarevic IZ, Brown SA, Buhr RG, Comellas AP, Cooper CB, Criner GJ, Dransfield MT, Drescher F, Folz RJ, Hansel NN, Kalhan R, Kaner RJ, Kanner RE, Krishnan JA, Lazarus SC, Maddipati V, Martinez FJ, Mathews A, Meldrum C, McEvoy C, Nyunoya T, Rogers L, Stringer WW, Wendt CH, Wise RA, Wisniewski SR, Sciurba FC, Woodruff PG; RETHINC Study Group. Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function. N Engl J Med. 2022 Sep 29;387(13):1173-1184. doi: 10.1056/NEJMoa2204752. Epub 2022 Sep 4.
- Pulmonary Trials Cooperative website, containing information regarding RETHINC and other studies included in the Pulmonary Trials CooperativeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MeiLan Han, MD, MS principal investigator
University of Michigan
Prescott Woodruff, MD, MPH principal investigator
University of California, San Francisco
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indacaterol/Glycopyrrolate in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Michigan at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (Percentage) of Individuals Who Experience a 4 Unit Improvement in St. George's Respiratory Questionnaire (SGRQ) at 12 Weeks and do Not Meet Criteria for Treatment Failure During the 12 Week Treatment Period (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02867761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.