Effect of Brovana and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)

NCT00773786 | Completed Phase 4 Results

• 1 other identifier: ASRC956
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this study will provide proof-of-concept information on whether the (anticipated) additional bronchodilator effect of Brovana added to tiotropium will lead to a meaningful improvement in the patient-centered outcome, exercise capacity. This study will only evaluate the effects of short-term (1-week) administration of Brovana. If results are positive, it would provide preliminary data for further, multicenter investigations.

Conditions

COPD

Keywords

COPD; Bronchodilator; arformoterol; tiotropium

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week

  Change from baseline in Forced Expiratory Volume in 1 second (FEV1) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline)

  baseline and 1 week

Secondary Outcomes (2)

• Change From Baseline in Forced Vital Capacity (FVC) at 1 Week

  baseline and 1 week

• Change From Baseline in Inspiratory Capacity at 1 Week

  baseline and 2 hours after dosing

Study Arms (2)

Arformoterol

EXPERIMENTAL

Arformoterol twice daily for 1 week via nebulizer

Drug: Arformoterol (Brovana)

Placebo

PLACEBO COMPARATOR

Placebo twice daily for 1 week

Drug: Placebo

Interventions

Arformoterol (Brovana) DRUG

twice daily via nebulizer added to maintenance daily tiotropium

Arformoterol

Placebo DRUG

Placebo twice daily for 1 week (added to maintenance tiotropium)

Placebo

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent (Approval by the St. Francis Hospital Institutional Review Board (IRB) will be required before study initiation)
• Adults, age \> 40 years
• A clinical diagnosis of COPD, with spirometric confirmation: post-bronchodilator forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) ( \< 0.70
• Moderate, severe and very severe airflow limitation by GOLD criteria.
• Clinically stable respiratory disease
• The perceived ability to participate in pulmonary testing and exercise testing
• COPD, stable state

You may not qualify if:

• Women of childbearing potential
• Asthma
• Supplemental oxygen use or anticipated oxygen desaturation \< 85% at peak exercise (patients who desaturate below 85% on the incremental study will be excluded)
• Co-morbidity that would interfere with the patient participating in the study, including the exercise testing. Examples include unstable cardiac disease, arthritis, psychological problems that would interfere with participation
• An exacerbation requiring therapy or any change in maintenance COPD therapy within six weeks of testing
• A history of a prolonged QT interval
• Recent exacerbation of COPD

Sponsors & Collaborators

• Trinity Health Of New England: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

St Francis Hospital and Medical center

Hartford, Connecticut, 06105, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Richard ZuWallack, MD
• Organization: Saint Francis Hospital and Medical Center

rzuwalla@stfranciscare.org

Study Officials

• Richard ZuWallack, MD

  Saint Frnacis Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 16, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 6, 2019
• Results First Posted: June 3, 2015

Record last verified: 2013-12

Locations

US (1)