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Trial record 28 of 190 for:    GLYCOPYRROLATE

Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02948582
Recruitment Status : Completed
First Posted : October 28, 2016
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sunovion Respiratory Development Inc.

Tracking Information
First Submitted Date  ICMJE October 26, 2016
First Posted Date  ICMJE October 28, 2016
Results First Submitted Date  ICMJE January 2, 2018
Results First Posted Date  ICMJE March 12, 2018
Last Update Posted Date March 12, 2018
Study Start Date  ICMJE July 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
  • Trough FEV1 (Change From Baseline) [ Time Frame: 24hr post dose ]
    Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of FEV1 values obtained at 23 hours 30 minutes and 24 hours post-dose of each Treatment Visit.
  • Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline). [ Time Frame: 0-12h post dose ]
    Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.. The standardized actual FEV1 AUC(0-12) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-12) was also calculated similarly, using the change from pre-dose FEV1.
  • Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline). [ Time Frame: 12-24h post dose ]
    Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized actual FEV1 AUC(12-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(12-24) was also calculated similarly, using the change from pre-dose FEV1.
  • Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline) [ Time Frame: 0 to 24h ]
    Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The standardized actual FEV1 AUC(0-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-24) was also calculated similarly, using the change from pre-dose FEV1.
  • Peak FEV1 (Change From Baseline and Percent Change) [ Time Frame: 0-4h post dose ]
    spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The peak FEV1 was defined as the highest post-dose FEV1 value within 4 hrs after the dose. Percent change from baseline was calculated as 100 times the difference of peak FEV1 minus baseline FEV1 divided by baseline FEV1.
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
  • Trough FEV1 (Change From Baseline) [ Time Frame: 24hr post dose ]
  • FEV1AUC0-12 Area under the FEV1 curve from 0 to 12 hours post-dose (actual and change from baseline). [ Time Frame: 0-12h post dose ]
  • FEV1AUC12-24 Area under the FEV1 curve from 12 to 24 hours post- dose (actual and change from baseline). [ Time Frame: 12-24h post dose ]
  • FEV1 AUC0-24 Area under the FEV1 curve from 0 to 24 hours post-dose (actual and change baseline) [ Time Frame: 0 to 24h ]
  • Peak FEV1 (Change From Baseline and Percent Change) [ Time Frame: 0-4h post dose ]
Change History Complete list of historical versions of study NCT02948582 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
  • Cmax; Maximum Observed Plasma Concentration [ Time Frame: 0 to 12 hour ]
    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
  • Tmax; Time to Maximum Observed Plasma Concentration [ Time Frame: 0 to 12 hours ]
    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
  • t1/2; Plasma Half-life [ Time Frame: 0 to 12 hour ]
    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
  • AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration. [ Time Frame: 0 to 12 hour ]
    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
  • AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity [ Time Frame: 0 to 12 hour ]
    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
  • Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE [ Time Frame: Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69) ]
    AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
  • Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study [ Time Frame: 0-24 h ]
    Vital signs were measured at screening and at each Treatment Visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment.
  • Number of Clinically Significant Abnormal Laboratory Results Reported During the Study [ Time Frame: Day -14, Day 69 ]
    Clinical safety lab parameters were collected at screening and at the post study assessment. Any laboratory values that were out of range of normal reference values were evaluated by the Investigators.
  • Number of Subjects With Clinically Significant ECG Parameters Reported During the Study [ Time Frame: 0 to 24h ]
    ECGs were recorded at screening and at each study treatment visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment.
  • Percentage of Subjects With Treatment Emergent AEs [ Time Frame: Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69) ]
    AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
  • Cmax; Maximum Observed Plasma Concentration [ Time Frame: 0 to 12 hour ]
    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
  • Tmax; Time to Maximum Observed Plasma Concentration [ Time Frame: 0 to 12 hours ]
    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
  • t1/2; Plasma Half-life [ Time Frame: 0 to 12 hour ]
    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
  • AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration. [ Time Frame: 0 to 12 hour ]
    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
  • AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity [ Time Frame: 0 to 12 hour ]
    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
  • Number of subjects who died, Number of subjects with treatment emergent SAEs, Number of subjects who discontinued due to AE, Percentage of subjects with treatment emergent AEs [ Time Frame: Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69) ]
  • Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study [ Time Frame: 0-24 h ]
  • Number of Clinically Significant Abnormal Laboratory Results Reported During the Study [ Time Frame: Day -14, Day 69 ]
  • Number of Subjects With Clinically Significant ECG Parameters Reported During the Study [ Time Frame: 0 to 24h ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE Randomized, Placebo-Controlled, Double-Blind, Dose Ranging, Single-Dose, 6-Way Crossover Study to Assess Safety, Efficacy and Pharmacokinetics of EP-101 Using eFlow Nebuliser in Patients With COPD
Brief Summary The study assessed the safety and ability of an orally inhaled medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered using an eFlow nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD). Each patient randomly received several, single doses of GIS, or placebo, separated by approximately 1 to 2 weeks. After the dose was given, lung airflow was measured over 24 hours and blood was collected to measure how much GIS was in the bloodstream. The study was conducted to find the once-a- day GIS dose that produced the highest improvement in lung airflow using the eFlow nebulizer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: Glycopyrrolate Inhalation Solution12.5μg
    Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily
    Other Name: GIS
  • Drug: Glycopyrrolate Inhalation Solution 50μg
    Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily
    Other Name: GIS
  • Drug: Glycopyrrolate Inhalation Solution 100μg
    Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily
    Other Name: GIS
  • Drug: Glycopyrrolate Inhalation Solution 200μg
    Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily
    Other Name: GIS
  • Drug: Glycopyrrolate Inhalation Solution 400μg
    Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily
    Other Name: GIS
  • Drug: Placebo 0.5mL
    Placebo 0.5mL via eFlow, once daily
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Glycopyrrolate Inhalation Solution12.5μg
    Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily
    Intervention: Drug: Glycopyrrolate Inhalation Solution12.5μg
  • Experimental: Glycopyrrolate Inhalation Solution 50μg
    Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily
    Intervention: Drug: Glycopyrrolate Inhalation Solution 50μg
  • Experimental: Glycopyrrolate Inhalation Solution 100μg
    Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily
    Intervention: Drug: Glycopyrrolate Inhalation Solution 100μg
  • Experimental: Glycopyrrolate Inhalation Solution 200μg
    Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily
    Intervention: Drug: Glycopyrrolate Inhalation Solution 200μg
  • Experimental: Glycopyrrolate Inhalation Solution 400μg
    Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily
    Intervention: Drug: Glycopyrrolate Inhalation Solution 400μg
  • Placebo Comparator: Placebo 0.5mL
    Placebo 0.5mL via e-flow nebulizer, once daily
    Intervention: Drug: Placebo 0.5mL
Publications * Leaker BR, Barnes PJ, Jones CR, Tutuncu A, Singh D. Efficacy and safety of nebulized glycopyrrolate for administration using a high efficiency nebulizer in patients with chronic obstructive pulmonary disease. Br J Clin Pharmacol. 2015 Mar;79(3):492-500. doi: 10.1111/bcp.12517.

*   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: October 27, 2016)
42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female patients aged 40 through 75 years, inclusive
  2. A clinical diagnosis of COPD according to the GOLD guidelines
  3. Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10
  4. Post-bronchodilator FEV1 30-70% of predicted normal at the Screening Visit
  5. Post-bronchodilator FEV1/FVC ratio < 0.70 at the Screening Visit
  6. Improvement in FEV1 >12% and 150 mL following inhalation of ipratropium bromide at the Screening Visit
  7. Ability to perform reproducible spirometry according to the ATS/ERS guidelines
  8. Willing to stay at the study site for approximately 30 hours on each treatment visit
  9. Willing and able to provide written informed consent

Exclusion Criteria:

  1. Females who are pregnant or lactating at the Screening Visit, or if of childbearing potential not using one of the following acceptable means of birth control throughout the study:

    • Abstinence
    • Post-menopausal for at least two years
    • Surgically sterile (i.e., tubal ligation, hysterectomy)
    • Oral contraceptives (taken for at least one month prior to the Screening Visit)
    • Approved implantable or injectable contraceptives (e.g., Norplant®, Depo-Provera® or equivalent)
    • Barrier methods (e.g., condoms with spermicide)
    • Intrauterine device (i.e., IUD)
    • Vasectomy of male partner
    • Non-heterosexual life style
  2. Current evidence or recent history of any clinically significant 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
  3. Recent history of hospitalization due to an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit
  4. Primary diagnosis of asthma
  5. Prior lung volume reduction surgery or history of chest/lung irradiation
  6. Regular use of daily oxygen therapy
  7. Use of systemic (eg, intramuscular or intravenous) steroids within 3 months prior to the Screening Visit
  8. Respiratory tract infection within 6 weeks prior to the Screening Visit
  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. Clinically significant abnormal ECG
  13. Positive Hepatitis B surface antigen or positive Hepatitis C antibody
  14. Positive screening test for HIV antibodies
  15. Current or recent history (previous 12 months) of excessive use or abuse of alcohol
  16. Current evidence or history of abusing legal drugs or use of illegal drugs or substances
  17. Donation of 450 mL of blood within 8 weeks of the Screening Visit
  18. History of hypersensitivity or intolerance to aerosol medications
  19. Participation in another investigational drug study was received within 30 days prior to the Screening Visit
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 40 Years to 75 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02948582
Other Study ID Numbers  ICMJE EP-101-02
2010-018987-17 ( EudraCT Number )
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 Chair: Ahmet Tutuncu, MD, PhD Elevation Pharmaceuticals, Inc., (now known as Sunovion Respriatory Developement Inc.)
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