- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02951312
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)
March 28, 2018 updated by: Sunovion Respiratory Development Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In Part I, 12 subjects were randomly allocated to one of 2 cohorts, running in parallel.
The 6 cohort 1 subjects received 25 mg and then 200 mg during their treatment periods 1 and 2, respectively.
The 6 cohort 2 subjects received 75mg, 500mg, and 1000 mg during their treatment periods 1, 2, and 3, respectively.
During Part II of the study, the same 12 subjects from Part I were randomized to receive either 200 mg jet or placebo in a 1:1 ratio.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female patients aged 40 through 75 years, inclusive
- A clinical diagnosis of COPD according to the GOLD guidelines
- 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)
- Post-bronchodilator FEV1 40-80% of predicted normal
- Post-bronchodilator FEV1/FVC ratio < 0.70
- Improvement in FEV1 >12% (minimum 150 mL) following inhalation of ipratropium bromide
- Ability to perform reproducible spirometry according to the ATS/ERS guidelines
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
- Willing and able to provide written informed consent
Exclusion Criteria:
- 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.
- 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.
- Regular use of daily oxygen therapy.
- Use of systemic (e.g., intramuscular or intravenous) steroids within 3 months prior to the Screening Visit
- Respiratory tract infection within 6 weeks prior to the Screening Visit
- 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
- Current or recent history (previous 12 months) of excessive use or abuse of alcohol
- Current evidence or history of abusing legal drugs or the use of illegal drugs or substances
- History of hypersensitivity or intolerance to aerosol medications
- Participation in another investigational drug study where drug was received within 30 days prior to the Screening Visit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Glycopyrrolate Inhalation Solution 25mg
Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily
|
25 μg oral inhalation via eFlow Nebulizer, once daily
Other Names:
|
EXPERIMENTAL: Glycopyrrolate Inhalation Solution 75mg
Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily
|
75 μg oral inhalation via eFlow Nebulizer, once daily
Other Names:
|
EXPERIMENTAL: Glycopyrrolate Inhalation Solution 200mg
Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily
|
200 μg oral inhalation via eFlow Nebulizer, once daily
Other Names:
|
EXPERIMENTAL: Glycopyrrolate Inhalation Solution 200mg Jet
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily
|
200 μg oral inhalation via inhalation via jet nebulizer, once daily
Other Names:
|
EXPERIMENTAL: Glycopyrrolate Inhalation Solution 500mg
Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily
|
500 μg oral inhalation via eFlow nebulizer, once daily
Other Names:
|
EXPERIMENTAL: Glycopyrrolate Inhalation Solution1000mg
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily
|
1000 μg oral inhalation via eFlow nebulizer, once daily
Other Names:
|
PLACEBO_COMPARATOR: Placebo 0.5 mL
Placebo 0.5 mL via jet nebulizer, once daily
|
Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Who Died
Time Frame: 0-47 days
|
0-47 days
|
|
Number of Subjects With Treatment Emergent SAEs
Time Frame: 0-47 days
|
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.
|
0-47 days
|
Number of Subjects Who Discontinued Due to AE
Time Frame: 0-47 days
|
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
|
0-47 days
|
Percentage of Subjects With Treatment Emergent AEs
Time Frame: 0-47 days
|
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
|
0-47 days
|
Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study
Time Frame: 30 hrs post dose
|
Vital signs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study assessment.
The clinical significance of each out of normal range vital sign parameter was determined by the investigator during the study.
|
30 hrs post dose
|
Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study
Time Frame: day 47 (post studyfollow-up assessment)
|
Clinical safety lab parameters were collected at screening and at the post study follow-up assessment.
The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.
|
day 47 (post studyfollow-up assessment)
|
Number of Subjects With Clinically Significant ECG Parameters Reported During the Study
Time Frame: 30hr post dose
|
ECGs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study follow-up assessment.
|
30hr post dose
|
Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study
Time Frame: post study follow-up assessment (Day 47)
|
Clinical safety lab parameters were collected at screening and at the post study follow-up assessment.
The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.
|
post study follow-up assessment (Day 47)
|
Number of Subjects With Treatment Emergent AEs
Time Frame: 0-47 days
|
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.
|
0-47 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 spirometry value collected at 24 hours post dose within each Treatment Period.
|
24hr post dose
|
Peak FEV1 (Percent Change)
Time Frame: 0 to 4hr
|
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
|
0 to 4hr
|
Peak FEV1 (Change From Baseline )
Time Frame: 0 to 4hr
|
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
|
0 to 4hr
|
FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline)
Time Frame: 0 to 24hr post dose
|
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
|
0 to 24hr post dose
|
Cmax Maximum Observed Plasma Concentration
Time Frame: 0 to 12 hours post dose
|
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
|
0 to 12 hours post dose
|
Tmax Time to Maximum Observed Plasma Concentration
Time Frame: 0 to 12 hours post dose
|
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
|
0 to 12 hours post dose
|
AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration
Time Frame: 0 to 12 hourr post dose
|
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
|
0 to 12 hourr post dose
|
AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity
Time Frame: 0 to 12 hours post dose
|
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
|
0 to 12 hours post dose
|
t1/2 Plasma Half-life
Time Frame: 0 to 12 hours post-dose
|
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr.
|
0 to 12 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ahmet Tutuncu, MD, PhD, Elevation Pharmaceuticals, Inc.(now known as Sunovion Respiratory Development Inc.)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (ACTUAL)
July 1, 2009
Study Completion (ACTUAL)
July 1, 2009
Study Registration Dates
First Submitted
October 26, 2016
First Submitted That Met QC Criteria
October 28, 2016
First Posted (ESTIMATE)
November 1, 2016
Study Record Updates
Last Update Posted (ACTUAL)
April 30, 2018
Last Update Submitted That Met QC Criteria
March 28, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Adjuvants, Anesthesia
- Pharmaceutical Solutions
- Glycopyrrolate
Other Study ID Numbers
- EP-101-01
- 2009-010821-38 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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