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

Information source: Prosonix Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: glycopyrronium bromide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Prosonix Limited

Official(s) and/or principal investigator(s):
Geoff Down, MB BS FFPM, Study Director, Affiliation: Prosonix Limited, Oxford, UK
Dave Singh, MA MD MRCP, Principal Investigator, Affiliation: Medicines Evaluation Unit, Manchester, UK

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.

Clinical Details

Official title: An Investigation of the Efficacy, Tolerability and Safety of a Range of Doses of Orally Inhaled Glycopyrronium Bromide (PSX1002-GB pMDI) in Male and Female Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)

Secondary outcome:

Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)

Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC)

Forced Expiratory Volume in one second (FEV1)

Forced Vital Capacity (FVC) Area Under the Curve (AUC)

Forced Expiratory Volume in one second (FEV1) / Forced Vital Capacity (FVC) ratio

Number of subjects reporting adverse events after each treatment as a measure of safety and tolerability

Systolic blood pressure

Diastolic blood pressure

Peripheral pulse rate

Electrocardiography (ECG)

Clinical hematology

Clinical chemistry

Plasma glycopyrronium bromide concentration-time Area Under the Curve (AUC)

Plasma glycopyrronium bromide peak concentration (Cmax)

Plasma glycopyrronium bromide time to maximum concentration (tmax)

Plasma glycopyrronium bromide concentration elimination half-life (t1/2)

Glycopyrronium bromide total plasma clearance following extravascular administration (CL/F)

Glycopyrronium bromide apparent volume of distribution following extravascular administration (Vz/F)

Eligibility

Minimum age: 40 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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:

- 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

Locations and Contacts

Medicines Evaluation Unit, Manchester M23 9QZ, United Kingdom
Additional Information

Starting date: May 2013
Last updated: October 17, 2013

Page last updated: August 23, 2015

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