Overview

A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
Summary
Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg 2x a day will be given as an active comparator.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sunovion Respiratory Development Inc.
Criteria
Inclusion Criteria:

1. Male or female patients 40 to 65 years-old, inclusive.

2. A clinical diagnosis of moderate to severe COPD according to the GOLD 2011 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 ≥ 40% and ≤ 70%
of predicted normal during Screening.

5. Post bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio ≤
0.70 during Screening.

6. Post bronchodilator (following inhalation of ipratropium bromide) improvement in FEV1
≥ 12% and ≥ 100 mL during Screening.

7. Ability to perform reproducible spirometry according to the American Thoracic Society
(ATS) and European Respiratory Society (ERS) guidelines (2005).

8. Female of child bearing potential (only) must have a negative serum pregnancy test at
Screening and be neither breastfeeding nor intending to become pregnant during study
participation. Females of childbearing potential must be instructed to and agree to
avoid pregnancy during the study. Female subjects of child bearing potential must use
an adequate method of birth control from Screening until 30 days after receiving study
drug and use contraception in addition to their partners using a barrier method.
Acceptable forms of contraception are as follows:

- Abstinence

- Barrier methods: condoms, diaphragms, cervical caps; with a spermicide foam, gel,
film, cream or suppository;

- Oral contraceptives

- Non hormone containing intrauterine methods: intrauterine devices or systems.

9. Willing and able to remain at the study site for at least 24 hours at Day 7 of each
Treatment Period.

10. Willing and able to attend all study visits and adhere to all study
assessments/procedures.

11. Willing and able to provide written informed consent

Exclusion Criteria:

1. Current evidence or recent history of any clinically significant and unstable 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.

2. Current evidence or history of a clinically significant abnormality of cardiac rhythm
and/or conduction including Holter monitoring prior to randomization.

3. Primary diagnosis of asthma.

4. 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.

5. Recent history of COPD exacerbation requiring hospitalization or need for increased
treatments for COPD within 6 weeks prior to Screening.

6. Use of daily oxygen therapy > 10 hours per day.

7. Use of systemic steroids within 3 months prior to Screening.

8. Respiratory tract infection within 6 weeks prior to or during Screening.

9. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.

10. History of urinary retention or bladder neck obstruction type symptoms.

11. History of narrow angle glaucoma.

12. Prolonged QTcF interval (males > 450 msec and females >470 msec) during Screening, or
history of long QT syndrome.

13. Recent history (previous 12 months) of excessive use or abuse of alcohol or
narcotic/illegal drugs.

14. History of hypersensitivity or intolerance to aerosol medications, beta-2 agonists, or
anticholinergics.

15. Participation in another investigational drug study where drug was received within 30
days prior to Screening, or current participation in another investigational drug
trial.

16. Subject is a staff member of the clinical site or a relative of a clinical site staff
member.