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A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD (GOLDEN 6)

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ClinicalTrials.gov Identifier: NCT02038829
Recruitment Status : Completed
First Posted : January 17, 2014
Results First Posted : January 25, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sunovion Respiratory Development Inc.

Tracking Information
First Submitted Date  ICMJE January 15, 2014
First Posted Date  ICMJE January 17, 2014
Results First Submitted Date  ICMJE January 2, 2018
Results First Posted Date  ICMJE January 25, 2018
Last Update Posted Date April 10, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo. [ Time Frame: Day 7 ]
Change History Complete list of historical versions of study NCT02038829 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2018)
  • Standardized Change From Baseline in FEV1 AUC(0-12hours) [ Time Frame: Day 7 ]
    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).
  • Number of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment) [ Time Frame: Over 7 days ]
    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.
  • Percentage of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment) [ Time Frame: Over 7 days ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
  • Standardized Change From Baseline in FEV1 AUC(0-12hours) [ Time Frame: Day 7 ]
  • Number and percentage of subjects with treatment-emergent adverse events (overall and by treatment) [ Time Frame: Over 7 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD
Official Title  ICMJE 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)
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COPD
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Drug: SUN101 3 mcg
    SUN-101 3 mcg bid
  • Drug: SUN-101 6.25 mcg
    SUN-101 6.25 mcg bid
  • Drug: SUN-101 12.5 mcg
    SUN-101 12.5 mcg bid
  • Drug: SUN-101 50 mcg
    SUN-101 50 mcg bid
  • Drug: Aclidinium
    Aclidinium 400 mcg bid
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo bid
    Intervention: Drug: Placebo
  • Experimental: SUN-101 3 mcg
    SUN-101 3 mcg bid
    Intervention: Drug: SUN101 3 mcg
  • Experimental: SUN-101 6.25 mcg
    SUN-101 6.25 mcg bid
    Intervention: Drug: SUN-101 6.25 mcg
  • Experimental: SUN-101 12.5 mcg
    SUN-101 12.5 mcg bid
    Intervention: Drug: SUN-101 12.5 mcg
  • Experimental: SUN-101 50 mcg
    SUN-101 50 mcg bid
    Intervention: Drug: SUN-101 50 mcg
  • Active Comparator: Aclidinium 400 mcg
    Aclidinium 400 mcg bid
    Intervention: Drug: Aclidinium
Publications * Donohue JF, Goodin T, Tosiello R, Wheeler A. Dose selection for glycopyrrolate/eFlow(®) 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.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2014)
96
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients 40 to 65 years-old, inclusive.
  2. A clinical diagnosis of moderate to severe COPD according to the GOLD 2011 guidelines.
  3. Current smokers or ex-smokers with at least 10 pack year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
  4. Post bronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 40% and ≤ 70% of predicted normal during Screening.
  5. Post bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio ≤ 0.70 during Screening.
  6. Post bronchodilator (following inhalation of ipratropium bromide) improvement in FEV1 ≥ 12% and ≥ 100 mL during Screening.
  7. Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
  8. 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.
  9. Willing and able to remain at the study site for at least 24 hours at Day 7 of each Treatment Period.
  10. Willing and able to attend all study visits and adhere to all study assessments/procedures.
  11. Willing and able to provide written informed consent

Exclusion Criteria:

  1. 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.
  2. Current evidence or history of a clinically significant abnormality of cardiac rhythm and/or conduction including Holter monitoring prior to randomization.
  3. Primary diagnosis of asthma.
  4. 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.
  5. Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening.
  6. Use of daily oxygen therapy > 10 hours per day.
  7. Use of systemic steroids within 3 months prior to Screening.
  8. Respiratory tract infection within 6 weeks prior to or during Screening.
  9. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
  10. History of urinary retention or bladder neck obstruction type symptoms.
  11. History of narrow angle glaucoma.
  12. Prolonged QTcF interval (males > 450 msec and females >470 msec) during Screening, or history of long QT syndrome.
  13. Recent history (previous 12 months) of excessive use or abuse of alcohol or narcotic/illegal drugs.
  14. History of hypersensitivity or intolerance to aerosol medications, beta-2 agonists, or anticholinergics.
  15. Participation in another investigational drug study where drug was received within 30 days prior to Screening, or current participation in another investigational drug trial.
  16. Subject is a staff member of the clinical site or a relative of a clinical site staff member.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02038829
Other Study ID Numbers  ICMJE SUN101-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunovion Respiratory Development Inc.
Study Sponsor  ICMJE Sunovion Respiratory Development Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: SUN101 Medical Director, MD Sunovion
PRS Account Sunovion Respiratory Development Inc.
Verification Date March 2018

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