COPDPhase 2GOLDEN 6NCT02038829

A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD

A Phase 2 study testing SUN101 3 mcg, SUN-101 6.25 mcg and SUN-101 12.5 mcg in people with COPD, run by Sunovion Respiratory Development Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg 2x a day will be given as an active comparator. Read more about this study

Who is it for?: Ages 40 to 65 years
Conditions the study is for: COPD
What is being tested?: SUN101 3 mcg, SUN-101 6.25 mcg and SUN-101 12.5 mcg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 10 sitesUnited States
Study dates: Jan 2014to May 2014
Phase: Phase 2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients 40 to 65 years-old, inclusive.
A clinical diagnosis of moderate to severe COPD according to the GOLD 2011 guidelines.
Current smokers or ex-smokers with at least 10 pack year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
Post bronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 40% and ≤ 70% of predicted normal during Screening.
Post bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio ≤ 0.70 during Screening.
Post bronchodilator (following inhalation of ipratropium bromide) improvement in FEV1 ≥ 12% and ≥ 100 mL during Screening.

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Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
Female of child bearing potential (only) must have a negative serum pregnancy test at Screening and be neither breastfeeding nor intending to become pregnant during study participation. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study. Female subjects of child bearing potential must use an adequate method of birth control from Screening until 30 days after receiving study drug and use contraception in addition to their partners using a barrier method. Acceptable forms of contraception are as follows:
Abstinence
Barrier methods: condoms, diaphragms, cervical caps; with a spermicide foam, gel, film, cream or suppository;
Oral contraceptives
Non hormone containing intrauterine methods: intrauterine devices or systems.
Willing and able to remain at the study site for at least 24 hours at Day 7 of each Treatment Period.
Willing and able to attend all study visits and adhere to all study assessments/procedures.
Willing and able to provide written informed consent

Who cannot join

Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
Current evidence or history of a clinically significant abnormality of cardiac rhythm and/or conduction including Holter monitoring prior to randomization.
Primary diagnosis of asthma.
History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin.
Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening.
Use of daily oxygen therapy > 10 hours per day.

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Use of systemic steroids within 3 months prior to Screening.
Respiratory tract infection within 6 weeks prior to or during Screening.
History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
History of urinary retention or bladder neck obstruction type symptoms.
History of narrow angle glaucoma.
Prolonged QTcF interval (males > 450 msec and females >470 msec) during Screening, or history of long QT syndrome.
Recent history (previous 12 months) of excessive use or abuse of alcohol or narcotic/illegal drugs.
History of hypersensitivity or intolerance to aerosol medications, beta-2 agonists, or anticholinergics.
Participation in another investigational drug study where drug was received within 30 days prior to Screening, or current participation in another investigational drug trial.
Subject is a staff member of the clinical site or a relative of a clinical site staff member.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

American Health Research, Inc.
Charlotte, North Carolina, 28207
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Palmetto Medical Research Associates, LLC
Easley, South Carolina, 29640
Greenville Pharmaceutical Research, Inc.
Greenville, South Carolina, 29615
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
North Carolina Clinical Research
Raleigh, North Carolina, 27607
S. Carolina
Spartanburg, South Carolina, 29303
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
CU Pharmaceutical Research
Union, South Carolina, 29379

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About this study

Official title: A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD: GOLDEN 6 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg 2x a day will be given as an active comparator.

Read the detailed description

This is a randomized, six-way crossover study to determine the efficacy and dose-response profile of SUN101. The study population will consist of subjects 40 to 65 years-old (inclusive), with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg bid will be given as an active comparator. The study will be double-blind for SUN-101 and placebo and will be open-label for aclidinium.

Conditions: COPD
Being tested: Placebo, SUN101 3 mcg, SUN-101 6.25 mcg, SUN-101 12.5 mcg, SUN-101 50 mcg
Keywords: COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo
SUN101 3 mcgDrug
SUN-101 3 mcg bid
SUN-101 6.25 mcgDrug
SUN-101 6.25 mcg bid
SUN-101 12.5 mcgDrug
SUN-101 12.5 mcg bid
SUN-101 50 mcgDrug
SUN-101 50 mcg bid
AclidiniumDrug
Aclidinium 400 mcg bid

Study groups in NCT02038829
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo bid Receives: Drug: Placebo
SUN-101 3 mcg	Experimental	SUN-101 3 mcg bid Receives: Drug: SUN101 3 mcg
SUN-101 6.25 mcg	Experimental	SUN-101 6.25 mcg bid Receives: Drug: SUN-101 6.25 mcg
SUN-101 12.5 mcg	Experimental	SUN-101 12.5 mcg bid Receives: Drug: SUN-101 12.5 mcg
SUN-101 50 mcg	Experimental	SUN-101 50 mcg bid Receives: Drug: SUN-101 50 mcg
Aclidinium 400 mcg	Active comparator	Aclidinium 400 mcg bid Receives: Drug: Aclidinium

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo.
Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the 2 spirometry values collected at 23 hours 15 minutes, and 23 hours 45 minutes post-morning dose on Day 7 of each Treatment Period. The FEV1 values within 6 hours after the use of rescue medication were considered as missing. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period
Measured: Baseline and Day 7

Secondary outcomes (3)

Standardized Change From Baseline in FEV1 AUC(0-12hours)
The standardized FEV1 AUC(0-12) on Day 7 was calculated using the trapezoidal rule from the changes in FEV1 from the baseline value (the mean of the two FEV1 values at 45 minutes and 15 minutes prior to morning dose at Day 1 of the respective Treatment Periods) and dividing by the actual length of the time interval).
Measured: Day 7
Number of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)
A treatment emergent adverse event (TEAE) is any TEAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any TEAE with both a missing start and stop date.
Measured: Over 7 days
Percentage of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)
A treatment emergent adverse event (TEAE) is any TEAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any TEAE with both a missing start and stop date.
Measured: Over 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014May 2014

First posted17 Jan 2014 (estimated)
Study startJan 2014
Primary completionMay 2014
Study completionMay 2014

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 COPDStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02038829
Sponsor's protocol ID: SUN101-201
Acronym: GOLDEN 6
Status last verified: Mar 2018
First submitted: 15 Jan 2014
Last updated: 10 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Donohue JF, Goodin T, Tosiello R, Wheeler A. Dose selection for glycopyrrolate/eFlow(R) phase III clinical studies: results from GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) phase II dose-finding studies. Respir Res. 2017 Dec 4;18(1):202. doi: 10.1186/s12931-017-0681-z.
PubMed 29202767

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD: GOLDEN 6 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)
ClinicalTrials.gov ID: NCT02038829
Acronym / sponsor ID: GOLDEN 6 / SUN101-201
Conditions: COPD
Keywords: COPD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Sunovion Respiratory Development Inc.Industry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 17 Jan 2014 (estimated)
Results: Posted 25 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg 2x a day will be given as an active comparator.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo bid
SUN-101 3 mcg	Experimental	Drug: SUN101 3 mcgSUN-101 3 mcg bid
SUN-101 6.25 mcg	Experimental	Drug: SUN-101 6.25 mcgSUN-101 6.25 mcg bid
SUN-101 12.5 mcg	Experimental	Drug: SUN-101 12.5 mcgSUN-101 12.5 mcg bid
SUN-101 50 mcg	Experimental	Drug: SUN-101 50 mcgSUN-101 50 mcg bid
Aclidinium 400 mcg	Active comparator	Drug: AclidiniumAclidinium 400 mcg bid

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Male or female patients 40 to 65 years-old, inclusive.
A clinical diagnosis of moderate to severe COPD according to the GOLD 2011 guidelines.
Current smokers or ex-smokers with at least 10 pack year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
Post bronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 40% and ≤ 70% of predicted normal during Screening.
Post bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio ≤ 0.70 during Screening.

Key exclusion criteria (16 listed)

Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
Current evidence or history of a clinically significant abnormality of cardiac rhythm and/or conduction including Holter monitoring prior to randomization.
Primary diagnosis of asthma.
History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin.
Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening.

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
PlaceboPlacebo	Drug	Placebo
SUN101 3 mcgSUN-101 3 mcg bid	Drug	SUN-101 3 mcg
SUN-101 6.25 mcgSUN-101 6.25 mcg bid	Drug	SUN-101 6.25 mcg
SUN-101 12.5 mcgSUN-101 12.5 mcg bid	Drug	SUN-101 12.5 mcg
SUN-101 50 mcgSUN-101 50 mcg bid	Drug	SUN-101 50 mcg
AclidiniumAclidinium 400 mcg bid	Drug	Aclidinium 400 mcg

Primary outcome

Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo.
Time frame: Baseline and Day 7
Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the 2 spirometry values collected at 23 hours 15 minutes, and 23 hours 45 minutes post-morning dose on Day 7 of each Treatment Period. The FEV1 values within 6 hours after the use of rescue medication were considered as missing. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period

3 secondary outcomes

Standardized Change From Baseline in FEV1 AUC(0-12hours)
Time frame: Day 7
Number of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)
Time frame: Over 7 days
Percentage of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)
Time frame: Over 7 days

Results and safety

Results posted to the registry on 25 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group 1	8	8
Treatment Group 2	8	8
Treatment Group 3	8	8
Treatment Group 4	8	8
Treatment Group 5	8	8
Treatment Group 6	8	8
Treatment Group 7	8	8
Treatment Group 8	8	8
Treatment Group 9	8	8
Treatment Group 10	8	8
Treatment Group 11	8	8
Treatment Group 12	8	8

Primary outcome: Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo.

Time frame: Baseline and Day 7. Least squares mean (Standard Error). Unit: liters

Measure	Placebo n = 92	SUN-101 3 mcg n = 91	SUN-101 6.25 mcg n = 92	SUN-101 12.5 mcg n = 90	SUN-101 50 mcg n = 92	Aclidinium 400 mcg n = 94
Value	-0.0282 (0.0300)	-0.0156 (0.0300)	0.0540 (0.0238)	0.0806 (0.0300)	0.1092 (0.0300)	0.1285 (0.0300)

Placebo vs SUN-101 3 mcg: LS Mean (SE): 0.0126 (95% CI -0.0318 to 0.0569), p = 0.9730, LS Mean (SE)
Placebo vs SUN-101 6.25 mcg: LS Mean (SE): 0.0822 (95% CI 0.0380 to 0.1264), p = 0.0014, LS Mean (SE)
Placebo vs SUN-101 12.5 mcg: LS Mean (SE): 0.1088 (95% CI 0.0644 to 0.1532), p <0.0001, LS Mean (SE)

Population analysed: Efficacy Population: all subjects who were randomized to treatment, received at least one dose of study medication, and had at least one trough FEV1 evaluation and the corresponding baseline FEV1 for at least one treatment period.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Over 7 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 92 (1.1%)	2 of 92 (2.2%)	Not reported
SUN-101 3 mcg	0 of 91 (0%)	6 of 91 (6.6%)	Not reported
SUN-101 6.25 mcg	2 of 92 (2.2%)	4 of 92 (4.3%)	Not reported
SUN-101 12.5 mcg	1 of 90 (1.1%)	6 of 90 (6.7%)	Not reported
SUN-101 50 mcg	0 of 92 (0%)	5 of 92 (5.4%)	Not reported
Aclidinium 400 mcg	3 of 94 (3.2%)	10 of 94 (10.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29202767Donohue JF, Goodin T, Tosiello R, Wheeler A. Dose selection for glycopyrrolate/eFlow(R) phase III clinical studies: results from GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) phase II dose-finding studies. Respir Res. 2017 Dec 4;18(1):202. doi: 10.1186/s12931-017-0681-z.

Related trials for COPD

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Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
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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.

SUN101 Medical Director, MD study director

Sumitomo Pharma America, Inc.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SUN101 3 mcg, SUN-101 6.25 mcg and SUN-101 12.5 mcg in people with COPD, run by Sunovion Respiratory Development Inc. at 10 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 15 inclusion and 16 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 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 25 Jan 2018). 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?

Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo. (time frame: Baseline and Day 7). 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 NCT02038829, 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 10 Apr 2018.