CompletedNCT01703624Updated Mar 30, 2016

Dose Ranging Study of Glycopyrronium Bromide in Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease

A Phase 2 interventional study of glycopyrronium bromide in Chronic Obstructive Pulmonary Disease, sponsored by Prosonix Limited. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-30.

Sponsored by Prosonix Limited · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 37
Allocation: Randomized
Ages: 40 Years to 70 Years
Sex: All

Study summary

This is an investigation of the beneficial effects, tolerability and safety of a range of single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a long term and progressive disease of the lungs, generally caused by cigarette smoking, but other factors may be involved. Glycopyrronium bromide (GB) appears to be particularly useful in dilating the constricted airways of such patients, with a duration of action variously described as being between 12 and 24 hours.

This study will investigate how well tolerated and safe this medication is at a range of doses. It will also help in the selection of a suitable dose for larger and repeat dose studies, based on measures of lung response. It will also help to determine how often the medication should be given; twice daily, or once daily.

Up to 40 patients will be enrolled into the study, ranging in age from 40 to 75 years of age. Patients will be medically assessed before participation to ensure their suitability. The study will take place in one centre in the UK over five sessions; at each session one dose (2 puffs) of GB or one dose (2 puffs) of placebo will be administered from a simple inhaler device. Neither staff nor patients will know which dose, or if placebo, is being taken. Lung function will be measured for up to 26 hours after the administration of each dose using standard spirometry equipment. Blood samples will be taken over a 24-hour period to check the blood levels of GB. There will be a period of about a week between each dosing session. Patients will be medically reviewed after the study to confirm that no untoward effects are present.

Conditions studied

Chronic Obstructive Pulmonary Disease

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Keywords

glycopyrronium bromide
glycopyrrolate
oral inhalation
COPD
chronic obstructive pulmonary disease
lung function
pharmacokinetics
tolerability
safety
cross-over
single-dose
dose-ranging

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 37 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

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Lead sponsor

This is the only study on the registry with Prosonix Limited as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female age 40-75 years, inclusive
A clinical diagnosis of moderate to severe COPD (GOLD guidelines)
Current smokers or ex-smokers with at least 10-pack year smoking history
Post-bronchodilator FEV1/FVC ratio \< 70 % at Screen
Post-bronchodilator FEV1 ≥ 40 % to \< 80 % of predicted at Screen
Demonstrated to be responsive to ipratropium (defined as at least an 100ml increase in FEV1 following ipratropium 80 µg)
Ability to perform acceptable spirometry (ATS/ERS guidelines)
Willing and able to provide written informed consent

Exclusion criteria

Exclusion Criteria:

Females who are pregnant or lactating at the Screening Visit, or if of childbearing potential not using an acceptable means of birth control throughout the study (defined in protocol)
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 (defined in protocol)
Recent history of hospitalisation due to an exacerbation of airway disease within three months prior to the Screening Visit or randomisation
Need for increased treatments of COPD within six weeks prior to the Screening Visit or randomisation
Primary diagnosis of asthma
Prior lung volume reductions surgery or history of chest/lung irradiation
Regular use of daily oxygen therapy
Use of systemic steroids within three months prior to the Screening Visit or during the run-in period
Respiratory tract infection within six weeks prior to the Screening Visit.
History of tuberculosis, bronchiectasis or other non-specific pulmonary disease
History of urinary retention or bladder neck obstructive type symptoms
History of narrow-angle glaucoma
Clinically significant abnormal ECG
Positive Hepatitis B antigen or positive Hepatitis C antibody
Positive screening test for HIV antibodies
Current evidence or history of excessive use or abuse of alcohol in the opinion of the Investigator
Current evidence or history of abusing legal drugs or use of illegal drugs or substances in the opinion of the Investigator
Donation of 450 ml or more of blood within eight weeks of the Screening Visit
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.
Inability to comply with study procedures or with study treatment intake, including inability to be trained and/or inability to demonstrate good inhaler technique with Vitalograph AIM

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 37 participants (actual)

Study arms

Experimental
glycopyrronium bromide 12.5mcg
glycopyrronium bromide 12.5mcg single dose via pressurised metered dose inhaler (pMDI)
Drug: glycopyrronium bromide
Experimental
glycopyrronium bromide 25mcg
glycopyrronium bromide 25mcg single dose via pressurised metered dose inhaler (pMDI)
Drug: glycopyrronium bromide
Experimental
glycopyrronium bromide 50mcg
glycopyrronium bromide 50mcg single dose via pressurised metered dose inhaler (pMDI)
Drug: glycopyrronium bromide
Experimental
glycopyrronium bromide 100mcg
glycopyrronium bromide 100mcg single dose via pressurised metered dose inhaler (pMDI)
Drug: glycopyrronium bromide
Placebo comparator
placebo
placebo single dose via pressurised metered dose inhaler (pMDI)
Drug: glycopyrronium bromide

Interventions

Drugglycopyrronium bromide
glycopyrronium bromide suspension in HFA
Also known as: PSX1002-GB

What researchers measure

Primary outcomes

Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)
FEV1 time-adjusted AUC(0-24 hours)
Time frame: From time zero to 24-hours

Secondary outcomes

Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)
FEV1 time-adjusted AUC(0-12 hours)
Time frame: From time zero to 12-hours
Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)
FEV1 time-adjusted AUC(12-24 hours)
Time frame: From 12 to 24-hours
Forced Expiratory Volume in one second (FEV1)
Serial FEV1 time-point assessments
Time frame: From time zero to 24-hours
Forced Vital Capacity (FVC) Area Under the Curve (AUC)
FVC time-adjusted AUC(0-24 hours), AUC(0-12 hours), AUC(12-24 hours), serial time-point assessment
Time frame: From time zero to 24-hours
Forced Expiratory Volume in one second (FEV1) / Forced Vital Capacity (FVC) ratio
Serial FEV1/FVC time-point assessment
Time frame: From time zero to 24-hours
Number of subjects reporting adverse events after each treatment as a measure of safety and tolerability
Adverse event monitoring will begin once a subject provides informed consent and will continue until study participation is concluded; incidence rates will be summarised by system organ class, preferred term, severity and by reported relationship to study drug for each treatment
Time frame: An average of 9 weeks
Systolic blood pressure
Descriptive statistics will be presented for the serial measurements by treatment
Time frame: From time zero to 24-hours
Diastolic blood pressure
Descriptive statistics will be presented for the serial measurements by treatment
Time frame: From time zero to 24-hours
Peripheral pulse rate
Descriptive statistics will be presented for the serial measurements by treatment
Time frame: From time zero to 24-hours
Electrocardiography (ECG)
Descriptive statistics will be presented for the serial measurements of each of the standard electrocardiographic (12-lead) parameters by treatment
Time frame: From time zero to 24-hours
Clinical hematology
Clinical hematology measures will be taken at the Screening Visit and at the Safety Follow-up Visit and will consist of: red blood cell count, hemoglobin, hematocrit, mean cell hemoglobin, mean cell hemoglobin concentration, mean cell volume, white blood cell count, differential white blood cell count and platelet count. Data will be summarised using descriptive statistics
Time frame: An average of 9 weeks
Clinical chemistry
Clinical chemistry measures will be taken at the Screening Visit and at the Safety Follow-up Visit and will consist of: sodium, potassium, urea, creatinine, uric acid, glucose, calcium, inorganic phosphorus, total bilirubin, alkaline phosphatase, alanine transaminase, aspartate transminase, gamma glutamyl transferase, creatine kinase, total protein, albumin, cholesterol and triglycerides. Data will be summarised using descriptive statistics
Time frame: An average of 9 weeks
Plasma glycopyrronium bromide concentration-time Area Under the Curve (AUC)
AUC (0-infinity) will be extrapolated from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
Time frame: From time zero to 24-hours
Plasma glycopyrronium bromide peak concentration (Cmax)
Cmax will be obtained from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
Time frame: From time zero to 24-hours
Plasma glycopyrronium bromide time to maximum concentration (tmax)
tmax will be calculated from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
Time frame: From time zero to 24-hours
Plasma glycopyrronium bromide concentration elimination half-life (t1/2)
t1/2 will be calculated from serial measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
Time frame: From time zero to 24-hours
Glycopyrronium bromide total plasma clearance following extravascular administration (CL/F)
CL/F will be calculated from serial plasma concentration measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
Time frame: From time zero to 24-hours
Glycopyrronium bromide apparent volume of distribution following extravascular administration (Vz/F)
Vz/F will be calculated from serial plasma concentration measures taken over time zero to 24-hours. The descriptive statistics presented by treatment will be: minimum, median, maximum, geometric mean, arithmetic mean and arithmetic standard deviation
Time frame: From time zero to 24-hours

Study locations

1 site

Medicines Evaluation Unit
Manchester, M23 9QZ, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01703624
Lead sponsor: Prosonix Limited
Responsible party: Sponsor
First posted: Oct 10, 2012
Start date: May 2013
Primary completion: Aug 2013
Completion: Sep 2013
Last update: Mar 30, 2016

Study contacts

Geoff Down, MB BS FFPM

study director · Prosonix Limited, Oxford, UK

Dave Singh, MA MD MRCP

principal investigator · Medicines Evaluation Unit, Manchester, UK

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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