A research study comparing the long term safety (48 weeks) of the investigational drug SUN101 (glycopyrrolate) given by a nebulizer, with tiotropium bromide inhalation powder (Spiriva®) in patients with Chronic Obstructive Pulmonary Disease (COPD).
- Conditions
- MedDRA version: 17.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-002696-18-CZ
- Lead Sponsor
- Sunovion Respiratory Development Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1050
1. Male or female patients age = 40 years, inclusive.
2. A clinical diagnosis of COPD according to the GOLD 2014 guidelines.
3. Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
4. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 < 80% of predicted normal and > 0.7 L during Screening (Visit 1).
5. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio < 0.70 during Screening (Visit 1).
6. Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS guidelines (2005).
7. Subject, if female = 65 years of age and of child bearing potential,
must have a negative serum pregnancy test at Visit 1. Females of
childbearing potential must be instructed to and agree to avoid
pregnancy during the study and must use an acceptable method of birth
control: a) an oral contraceptive, an intrauterine device (IUD),
implantable contraceptive, transdermal or injectable contraceptive for at
least 1 month prior to entering the study with continued use throughout
the study and for thirty days following participation; b) barrier method
of contraception, eg, condom and /or diaphragm with spermicide while
participating in the study; and/or c) abstinence.
8. Willing and able to provide written informed consent.
9. Willing and able to attend all study visits and adhere to all study assessments and procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 630
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 420
1. Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject.
2. Concomitant clinically significant respiratory disease other than COPD(eg, asthma, tuberculosis, bronchiectasis or other non-specific pulmonary disease).
3. Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening (Visit 1).
4. Use of daily oxygen therapy > 12 hours per day.
5. Respiratory tract infection within 6 weeks prior to Screening (Visit 1).
6. Use of systemic steroids within 3 months prior to Screening (Visit 1).
7. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin.
8. Prolonged QTc (> 450 msec for males and (> 470 msec for females) during Screening (Visit 1), or history of long QT syndrome.
9. History of or clinically significant ongoing bladder outlflow obstruction or history of catheterization for relief of bladder outlflow obstruction within the previous 6 months.
10. History of narrow-angle glaucoma.
11. History of hypersensitivity or intolerance to aerosol medications.
12. Recent documented history (within the previous 3 months) of substance abuse.
13. Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator.
14. Participation in another investigational drug study where drug was received within 30 days prior to Screening (Visit 1), or current participation in another investigational drug trial, including a SUN 101 study.
15. Previously received SUN-101 (active treatment; formerly known as EP 101).
16. Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): • Number and percentage of subjects with treatment-emergent adverse events (TEAE)<br>• Number and percentage of subjects with treatment-emergent serious adverse events (SAE)<br>• Number and percentage of subjects who discontinue the study due to TEAE;Timepoint(s) of evaluation of this end point: 48 weeks;Main Objective: The primary objective of this study is to assess the long-term safety and tolerability of SUN-101 given as 50 mcg twice daily over 48 weeks of treatment.;Secondary Objective: The secondary objective of this study is to assess the long-term efficacy of SUN-101 given as 50 mcg twice daily over 48 weeks of treatment.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Number and percentage of subjects with major adverse cardiac events (MACE), including cardiovascular death, ischemia/infarction, and stroke.<br><br>The secondary efficacy endpoint is mean change from baseline over 48 weeks in trough FEV1 for all subjects. ;Timepoint(s) of evaluation of this end point: 48 weeks