Phase 2
Completed N=12
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)
Source: ClinicalTrials.gov NCT02951312 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Number of Subjects Who Died — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Died |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Treatment Emergent SAEs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Who Discontinued Due to AE |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Subjects With Treatment Emergent AEs |
33.3; 33.3; 66.7; 33.3; 0.0; 33.3 | — |
| PRIMARY Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Clinically Significant ECG Parameters Reported During the Study |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Treatment Emergent AEs |
2; 2; 4; 2; 0; 2 | — |
| SECONDARY Trough FEV1 (Change From Baseline) |
0.038; 0.087; 0.138; -0.013; -0.017; 0.065 | — |
| SECONDARY Peak FEV1 (Percent Change) |
17.12; 15.60; 22.98; 19.28; 11.47; 16.87 | — |
| SECONDARY Peak FEV1 (Change From Baseline ) |
0.212; 0.255; 0.303; 0.233; 0.177; 0.283 | — |
| SECONDARY FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline) |
1.59; 3.10; 3.19; 1.35; 1.53; 3.08 | — |
| SECONDARY Cmax Maximum Observed Plasma Concentration |
177.242; 75.530; 749.872; 1534.057 | — |
| SECONDARY Tmax Time to Maximum Observed Plasma Concentration |
.025; 0.08; 0.25; 0.17 | — |
| SECONDARY AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration |
429.335; 26.176; 2014.276; 4084.763 | — |
| SECONDARY AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity |
563.416; 65.013; 2491.803; 5271.099 | — |
| SECONDARY t1/2 Plasma Half-life |
2.947; 0.778; 6.298; 7.573 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02951312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.