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

NCT02038829 | Completed Phase 2 Results

• 1 other identifier: SUN101-201
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

COPD

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo.

  Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the 2 spirometry values collected at 23 hours 15 minutes, and 23 hours 45 minutes post-morning dose on Day 7 of each Treatment Period. The FEV1 values within 6 hours after the use of rescue medication were considered as missing. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period

  Baseline and Day 7

Secondary Outcomes (3)

• Standardized Change From Baseline in FEV1 AUC(0-12hours)

  Day 7

• Number of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)

  Over 7 days

• Percentage of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)

  Over 7 days

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Placebo bid

Drug: Placebo

SUN-101 3 mcg

EXPERIMENTAL

SUN-101 3 mcg bid

Drug: SUN101 3 mcg

SUN-101 6.25 mcg

EXPERIMENTAL

SUN-101 6.25 mcg bid

Drug: SUN-101 6.25 mcg

SUN-101 12.5 mcg

EXPERIMENTAL

SUN-101 12.5 mcg bid

Drug: SUN-101 12.5 mcg

SUN-101 50 mcg

EXPERIMENTAL

SUN-101 50 mcg bid

Drug: SUN-101 50 mcg

Aclidinium 400 mcg

ACTIVE COMPARATOR

Aclidinium 400 mcg bid

Drug: Aclidinium

Interventions

Placebo DRUG

Placebo

Placebo

SUN101 3 mcg DRUG

SUN-101 3 mcg bid

SUN-101 3 mcg

SUN-101 6.25 mcg DRUG

SUN-101 6.25 mcg bid

SUN-101 6.25 mcg

SUN-101 12.5 mcg DRUG

SUN-101 12.5 mcg bid

SUN-101 12.5 mcg

SUN-101 50 mcg DRUG

SUN-101 50 mcg bid

SUN-101 50 mcg

Aclidinium DRUG

Aclidinium 400 mcg bid

Aclidinium 400 mcg

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 40 to 65 years-old, inclusive.
• A clinical diagnosis of moderate to severe COPD according to the GOLD 2011 guidelines.
• Current smokers or ex-smokers with at least 10 pack year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
• Post bronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 40% and ≤ 70% of predicted normal during Screening.
• Post bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio ≤ 0.70 during Screening.
• Post bronchodilator (following inhalation of ipratropium bromide) improvement in FEV1 ≥ 12% and ≥ 100 mL during Screening.
• Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
• 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.
• Willing and able to remain at the study site for at least 24 hours at Day 7 of each Treatment Period.
• Willing and able to attend all study visits and adhere to all study assessments/procedures.
• Willing and able to provide written informed consent

You may not qualify if:

• 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.
• Current evidence or history of a clinically significant abnormality of cardiac rhythm and/or conduction including Holter monitoring prior to randomization.
• Primary diagnosis of asthma.
• 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.
• Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening.
• Use of daily oxygen therapy \> 10 hours per day.
• Use of systemic steroids within 3 months prior to Screening.
• Respiratory tract infection within 6 weeks prior to or during Screening.
• History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
• History of urinary retention or bladder neck obstruction type symptoms.
• History of narrow angle glaucoma.
• Prolonged QTcF interval (males \> 450 msec and females \>470 msec) during Screening, or history of long QT syndrome.
• Recent history (previous 12 months) of excessive use or abuse of alcohol or narcotic/illegal drugs.
• History of hypersensitivity or intolerance to aerosol medications, beta-2 agonists, or anticholinergics.
• Participation in another investigational drug study where drug was received within 30 days prior to Screening, or current participation in another investigational drug trial.

Sponsors & Collaborators

• Sunovion Respiratory Development Inc.: lead

Study Sites (10)

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

American Health Research, Inc.

Charlotte, North Carolina, 28207, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, 97504, United States

Location

Palmetto Medical Research Associates, LLC

Easley, South Carolina, 29640, United States

Location

Greenville Pharmaceutical Research, Inc.

Greenville, South Carolina, 29615, United States

Location

Upstate Pharmaceutical Research

Greenville, South Carolina, 29615, United States

Location

S. Carolina

Spartanburg, South Carolina, 29303, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

CU Pharmaceutical Research

Union, South Carolina, 29379, United States

Location

Related Publications (1)

• Donohue JF, Goodin T, Tosiello R, Wheeler A. Dose selection for glycopyrrolate/eFlow(R) phase III clinical studies: results from GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) phase II dose-finding studies. Respir Res. 2017 Dec 4;18(1):202. doi: 10.1186/s12931-017-0681-z.

  PMID: 29202767 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

aclidinium bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Respiratory Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

1-866-503-6351

Study Officials

• SUN101 Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 17, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 10, 2018
• Results First Posted: January 25, 2018

Record last verified: 2018-03

Locations

US (10)