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Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered With an Electronic eFlow Nebulizer System 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:
NCT02951312
First received: October 26, 2016
Last updated: October 28, 2016
Last verified: October 2016
  Purpose
The study assessed the safety and ability of several doses of an orally inhaled medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared between the two nebulizer systems to determine what effect the device had on GIS delivery.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Drug: Glycopyrrolate Inhalation Solution 25mg Drug: Glycopyrrolate Inhalation Solution 75mg Drug: Glycopyrrolate Inhalation Solution 200mg Drug: Glycopyrrolate Inhalation Solution 200mg Jet Drug: Glycopyrrolate Inhalation Solution 500mg Drug: Glycopyrrolate Inhalation Solution1000mg Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single-dose, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Bronchodilatory Effects of Glycopyrrolate Inhalation Solution (GIS) Using a High Efficiency Nebulizer in Patients With COPD

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of subjects who died [ Time Frame: 0-47 days ]
  • Number of subjects with treatment emergent SAEs [ Time Frame: 0-47 days ]
  • Number of subjects who discontinued due to AE [ Time Frame: 0-47 days ]
  • Percentage of subjects with treatment emergent AEs [ Time Frame: 0-47 days ]
  • Number of subjects with clinically significant abnormal vital signs reported during the study [ Time Frame: 30hr post dose ]
  • Number of clinically significant abnormal laboratory results reported during the study [ Time Frame: Day 47 ]
  • Number of subjects with clinically significant ECG parameters reported during the study [ Time Frame: 30hrs post dose ]
  • Number of clinically significant abnormal laboratory results reported during the study [ Time Frame: Day 14 ]

Secondary Outcome Measures:
  • trough FEV1 (change from baseline) [ Time Frame: 24hr post dose ]
  • Peak FEV1 (percent change) [ Time Frame: 0 to 4hr ]
  • Peak FEV1 (change from baseline ) [ Time Frame: 0 to 4hr ]
  • FEV1 AUC0-24 Area under the FEV1 over time curve (change from baseline) [ Time Frame: 0 to 24hr ]
  • FEV1 AUC0-24 Area under the FEV1 over time curve (actual ) [ Time Frame: 0 to 24hr ]
  • Cmax 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

  • 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

  • AUC0-t Area under the plasma concentration-time curve from time zero to the last quantifiable 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

  • AUC0-inf Area under the plasma concentration-time curve from time zero to infinity [ 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 hours ]
    Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr


Enrollment: 12
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glycopyrrolate Inhalation Solution 25mg
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
Drug: Glycopyrrolate Inhalation Solution 25mg
25 μg oral inhalation via eFlow Nebulizer, once daily
Other Name: GIS
Experimental: Glycopyrrolate Inhalation Solution 75mg
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
Drug: Glycopyrrolate Inhalation Solution 75mg
75 μg oral inhalation via eFlow Nebulizer, once daily
Other Name: GIS
Experimental: Glycopyrrolate Inhalation Solution 200mg
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
Drug: Glycopyrrolate Inhalation Solution 200mg
200 μg oral inhalation via eFlow Nebulizer, once daily
Other Name: GIS
Experimental: Glycopyrrolate Inhalation Solution 200mg Jet
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
Drug: Glycopyrrolate Inhalation Solution 200mg Jet
200 μg oral inhalation via inhalation via jet nebulizer, once daily
Other Name: GIS
Experimental: Glycopyrrolate Inhalation Solution 500mg
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
Drug: Glycopyrrolate Inhalation Solution 500mg
500 μg oral inhalation via eFlow nebulizer, once daily
Other Name: GIS
Experimental: Glycopyrrolate Inhalation Solution1000mg
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
Drug: Glycopyrrolate Inhalation Solution1000mg
1000 μg oral inhalation via eFlow nebulizer, once daily
Other Name: GIS
Placebo Comparator: Placebo 0.5 mL
Placebo 0.5 mL via jet nebulizer, once daily
Drug: Placebo
Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 years, or 10 packs/day for 1 year)
  4. Post-bronchodilator FEV1 40-80% of predicted normal
  5. Post-bronchodilator FEV1/FVC ratio < 0.70
  6. Improvement in FEV1 >12% (minimum 150 mL) following inhalation of ipratropium bromide
  7. Ability to perform reproducible spirometry according to the ATS/ERS guidelines
  8. If female and of childbearing potential, must have had a negative pregnancy test and was not lactating at the Screening Visit, and was using one of the following acceptable means of birth control throughout the study:

    • Post-menopausal for at least two years
    • Surgically sterile
    • 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
  9. Willing and able to provide written informed consent

Exclusion Criteria:

  1. 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 patients at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infraction, hypertension, arrhythmia, diabetes, neurological or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
  2. Recent history of an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit.
  3. Regular use of daily oxygen therapy.
  4. Use of systemic (e.g., intramuscular or intravenous) steroids within 3 months prior to the Screening Visit
  5. Respiratory tract infection within 6 weeks prior to the Screening Visit
  6. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease
  7. History of urinary retention or bladder neck obstruction type symptoms
  8. History of narrow-angle glaucoma
  9. Current or recent history (previous 12 months) of excessive use or abuse of alcohol
  10. Current evidence or history of abusing legal drugs or the use of illegal drugs or substances
  11. History of hypersensitivity or intolerance to aerosol medications
  12. Participation in another investigational drug study where drug 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: NCT02951312

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

Responsible Party: Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier: NCT02951312     History of Changes
Other Study ID Numbers: EP-101-01
2009-010821-38 ( EudraCT Number )
Study First Received: October 26, 2016
Last Updated: October 28, 2016

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

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 June 23, 2017