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Beta-2 Agonist

Brovana (nebulized arformoterol) for CPFE Syndrome

Phase 4
Waitlist Available
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This is a PI-initiated study taking place only at UCLA, sponsored by Sunovion. The investigators plan to enroll about 20 subjects who are at least 40 years old and have Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to compare the effectiveness of Brovana and Serevent in helping relieve COPD symptoms. Specifically, the investigators are looking at how much and for how long the two drugs can open up the small airways in the lungs. This will be done with breathing tests on all subjects, and with high resolution CT scans on subjects who agree to this optional part of the study. Half of subjects will take Brovana (arformoterol tartrate inhalation solution) for 2 weeks and then Serevent (salmeterol xinafoate inhalation powder) for 2 weeks; the other half will take Serevent the first two weeks and Brovana the second two weeks. All subjects will also take Spiriva (tiotropium) and will be provided with albuterol for immediate relief of symptoms. After a Screening Visit to determine eligibility, subjects will be randomly assigned to receive Brovana or Serevent for the first 2 weeks, complete Test Visit 1, then receive the other study drug for 2 weeks, and finally complete Test Visit 2. Visits will include questionnaires, review of health and medications, and breathing tests before and after taking the study drug. Subjects who agree to be in the sub-study will also undergo CT scans before and after taking the study drug at both test visits.

Eligible Conditions
  • CPFE Syndrome
  • Bronchitis
  • Chronic Obstructive Pulmonary Disease
  • Emphysema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Inspiratory capacity (absolute volume BTPS, L)
Secondary study objectives
Inspiratory capacity (%ref TLC)
Inspiratory capacity (absolute change, % change, %predicted change)
Other breathing test outcomes

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Serevent (Salmeterol dry powder inhaler)Experimental Treatment1 Intervention
Serevent (Salmeterol dry powder inhaler) treatment for 2 weeks
Group II: Brovana (nebulized arformoterol)Experimental Treatment1 Intervention
Brovana (nebulized arformoterol) treatment for 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Salmeterol
FDA approved

Find a Location

Who is running the clinical trial?

SunovionIndustry Sponsor
189 Previous Clinical Trials
49,353 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,566 Previous Clinical Trials
10,263,434 Total Patients Enrolled
Sumitomo Pharma America, Inc.Industry Sponsor
241 Previous Clinical Trials
51,865 Total Patients Enrolled
~1 spots leftby Nov 2025