Dose ranging study of glycopyrronium bromide in moderate/severe COPD

• Conditions: Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 14.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-003791-40-GB
• Lead Sponsor: Prosonix Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-09
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female age 40-75 years, inclusive
2. A clinical diagnosis of moderate to severe COPD according to the GOLD guidelines
3. Current smokers or ex-smokers with at least 10-pack year smoking history (e.g., at least one pack/day for 10 years, or 10 packs/day for one year
4. Post-bronchodilator FEV1/FVC ratio < 70 % at Screen
5. Post-bronchodilator FEV1 = 40 % to < 80 % of predicted at Screen
6. Demonstrated to be responsive to ipratropium (defined as at least an 100ml increase in FEV1 following ipratopium 80 µg)
7. Ability to perform acceptable spirometry according to the ATS/ERS guidelines
8. Willing and able to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Females who are pregnant or lactating at the Screening Visit, or if of childbearing potential not using one of the following acceptable means of birth control throughout the study:
a. Established use of oral, injected or implanted hormonal methods of contraception (for at least one month prior to the Screening Visit)
b. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
d. True abstinence when this is in line with the subject’s preferred and usual lifestyle. (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not considered acceptable methods of contraception).
e. Bilateral tubal ligation
Females are considered to be of childbearing potential unless either:
a. Permanently sterilised (e.g. bilateral salpingectomy, bilateral oophorectomy or hysterectomy) or;
b. Postmenopausal (i.e. spontaneous amenorrhoea for at least 2 years)
2. 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; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities
3. Recent history of hospitalisation due to an exacerbation of airway disease within three months prior to the Screening Visit or randomisation
4. Need for increased treatments of COPD within six weeks prior to the Screening Visit or randomisation
5. Primary diagnosis of asthma
6. Prior lung volume reductions surgery or history of chest/lung irradiation
7. Regular use of daily oxygen therapy
8. Use of systemic steroids within three months prior to the Screening Visit or during the run-in period
9. Respiratory tract infection within six weeks prior to the Screening Visit. Respiratory tract infections acquired during the run-in period will be assessed by the Investigator to determine suitability to continue in the study.
10. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease
11. History of urinary retention or bladder neck obstructive type symptoms
12. History of narrow-angle glaucoma
13. Clinically significant abnormal ECG
14. Positive Hepatitis B antigen or positive Hepatitis C antibody
15. Positive screening test for HIV antibodies
16. Current evidence or history of excessive use or abuse of alcohol in the opinion of the Investigator
17. Current evidence or history of abusing legal drugs or use of illegal drugs or substances in the opinion of the Investigator
18. Donation of 450 ml or more of blood within eight weeks of the Screening Visit
19. History of hypersensitivity or intolerance to aerosol medications
20. Participation in another investigational drug study where drug was received within 30 days prior to the Screening Visit.
21. 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified