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)

NCT02951312 | Completed Phase 2 Results

• 2 other identifiers: EP-101-012009-010821-38
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Emphysema; Chronic bronchitis; COPD; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (9)

• Number of Subjects Who Died

  0-47 days

• Number of Subjects With Treatment Emergent SAEs

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (9)

• Trough FEV1 (Change From Baseline)

  24hr post dose

• Peak FEV1 (Percent Change)

  0 to 4hr

• Peak FEV1 (Change From Baseline )

  0 to 4hr

• FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline)

  0 to 24hr post dose

• Cmax Maximum Observed Plasma Concentration

  0 to 12 hours post dose

Study Arms (7)

Glycopyrrolate Inhalation Solution 25mg

EXPERIMENTAL

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Drug: Glycopyrrolate Inhalation Solution 25mg

Glycopyrrolate Inhalation Solution 75mg

EXPERIMENTAL

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Drug: Glycopyrrolate Inhalation Solution 75mg

Glycopyrrolate Inhalation Solution 200mg

EXPERIMENTAL

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Drug: Glycopyrrolate Inhalation Solution 200mg

Glycopyrrolate Inhalation Solution 200mg Jet

EXPERIMENTAL

Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily

Drug: Glycopyrrolate Inhalation Solution 200mg Jet

Glycopyrrolate Inhalation Solution 500mg

EXPERIMENTAL

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Drug: Glycopyrrolate Inhalation Solution 500mg

Glycopyrrolate Inhalation Solution1000mg

EXPERIMENTAL

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Drug: Glycopyrrolate Inhalation Solution1000mg

Placebo 0.5 mL

PLACEBO COMPARATOR

Placebo 0.5 mL via jet nebulizer, once daily

Drug: Placebo

Interventions

Glycopyrrolate Inhalation Solution 25mg DRUG

25 μg oral inhalation via eFlow Nebulizer, once daily

Also known as: GIS

Glycopyrrolate Inhalation Solution 25mg

Glycopyrrolate Inhalation Solution 75mg DRUG

75 μg oral inhalation via eFlow Nebulizer, once daily

Also known as: GIS

Glycopyrrolate Inhalation Solution 75mg

Glycopyrrolate Inhalation Solution 200mg DRUG

200 μg oral inhalation via eFlow Nebulizer, once daily

Also known as: GIS

Glycopyrrolate Inhalation Solution 200mg

Glycopyrrolate Inhalation Solution 200mg Jet DRUG

200 μg oral inhalation via inhalation via jet nebulizer, once daily

Also known as: GIS

Glycopyrrolate Inhalation Solution 200mg Jet

Glycopyrrolate Inhalation Solution 500mg DRUG

500 μg oral inhalation via eFlow nebulizer, once daily

Also known as: GIS

Glycopyrrolate Inhalation Solution 500mg

Glycopyrrolate Inhalation Solution1000mg DRUG

1000 μg oral inhalation via eFlow nebulizer, once daily

Also known as: GIS

Glycopyrrolate Inhalation Solution1000mg

Placebo DRUG

Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Placebo 0.5 mL

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunovion Respiratory Development Inc.: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Results Point of Contact

• Title: Respiratory Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

1-866-503-6351

Study Officials

• Ahmet Tutuncu, MD, PhD

  Elevation Pharmaceuticals, Inc.(now known as Sunovion Respiratory Development Inc.)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 1, 2016
• Study Start: May 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 30, 2018
• Results First Posted: April 30, 2018

Record last verified: 2018-03