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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier:
NCT02948582
First received: October 26, 2016
Last updated: October 27, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Drug: Glycopyrrolate Inhalation Solution12.5mg Drug: Glycopyrrolate Inhalation Solution 50mg Drug: Glycopyrrolate Inhalation Solution 100mg Drug: Glycopyrrolate Inhalation Solution 200mg Drug: Glycopyrrolate Inhalation Solution 400mg Drug: Placebo 0.5mL Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sunovion Respiratory Development Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glycopyrrolate Inhalation Solution12.5mg
Glycopyrrolate Inhalation Solution12.5mg via e-flow nebulizer, once daily
Drug: Glycopyrrolate Inhalation Solution12.5mg
Glycopyrrolate Inhalation Solution12.5mg via eFlow, once daily
Other Name: GIS
Experimental: Glycopyrrolate Inhalation Solution 50mg
Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily
Drug: Glycopyrrolate Inhalation Solution 50mg
Glycopyrrolate Inhalation Solution 50mg via eFlow, once daily
Other Name: GIS
Experimental: Glycopyrrolate Inhalation Solution 100mg
Glycopyrrolate Inhalation Solution 100mg via e-flow nebulizer, once daily
Drug: Glycopyrrolate Inhalation Solution 100mg
Glycopyrrolate Inhalation Solution 100mg via eFlow, once daily
Other Name: GIS
Experimental: Glycopyrrolate Inhalation Solution 200mg
Glycopyrrolate Inhalation Solution 200mg via e-flow nebulizer, once daily
Drug: Glycopyrrolate Inhalation Solution 200mg
Glycopyrrolate Inhalation Solution 200mg via eFlow, once daily
Other Name: GIS
Experimental: Glycopyrrolate Inhalation Solution 400mg
Glycopyrrolate Inhalation Solution 400mg via e-flow nebulizer, once daily
Drug: Glycopyrrolate Inhalation Solution 400mg
Glycopyrrolate Inhalation Solution 400mg via eFlow, once daily
Other Name: GIS
Placebo Comparator: Placebo 0.5mL
Placebo 0.5mL via e-flow nebulizer, once daily
Drug: Placebo 0.5mL
Placebo 0.5mL via eFlow, once daily
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02948582

Sponsors and Collaborators
Sunovion Respiratory Development Inc.
Investigators
Study Chair: Ahmet Tutuncu, MD, PhD Elevation Pharmaceuticals, Inc., (now known as Sunovion Respriatory Developement Inc.)
  More Information

Responsible Party: Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier: NCT02948582     History of Changes
Other Study ID Numbers: EP-101-02
2010-018987-17 ( EudraCT Number )
Study First Received: October 26, 2016
Last Updated: October 27, 2016

Keywords provided by Sunovion Respiratory Development Inc.:
Chronic Obstructive Pulmonary Disease
COPD
Emphysema
Chronic bronchitis

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Pharmaceutical Solutions
Glycopyrrolate
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017