Sunovion Brovana Versus Serevent Inspiratory Capacity High Resolution Computed Tomography

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Eric Kleerup, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01361984
First received: May 23, 2011
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
COPD
Emphysema
Chronic Bronchitis
Drug: Nebulized arformoterol
Drug: Salmeterol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inspiratory Capacity and HRCT Comparison of Nebulized Arformoterol (Brovana) vs. Dry-powder Inhaler Salmeterol (Serevent)

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Inspiratory capacity (absolute volume BTPS, L) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The inspiratory capacity (absolute volume BTPS, L) measured 3 times prior to treatment and 5-6 times after treatment will be contrasted between the two treatments (nebulized arformoterol and DPI salmeterol) using a mixed effects linear model. The model will include treatment order, albuterol response FEV1 in mL, time of day and whether the IC was from plethysmography and time of prior dose of study med (nominal 12 hours).


Secondary Outcome Measures:
  • Inspiratory capacity (absolute change, % change, %predicted change) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Inspiratory capacity: evaluated as absolute change, % change, %predicted change. Considered at predose (trough) and AUC 75-195 minutes after dose

  • Inspiratory capacity (%ref TLC) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Inspiratory capacity as percent of reference total lung capacity

  • Other breathing test outcomes [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    FEV1, FVC, isovolume FEF25-75% referenced to pre-albuterol FVC at screening visit, SVCexp (from spirometric and plethysmographic measures), FRC, RV, ERV, IRV, RV/TLC, TLC, IC/TLC


Estimated Enrollment: 20
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brovana (nebulized arformoterol)
Brovana (nebulized arformoterol) treatment for 2 weeks
Drug: Nebulized arformoterol
Arformoterol tartrate 15 µg/2ml (Brovana) nebulized via PARI-LC Plus® nebulizer with a mouthpiece, connected to a PRONEB® Ultra compressor. The nebulization time is ~9 minutes
Other Name: Brovana
Experimental: Serevent (Salmeterol dry powder inhaler)
Serevent (Salmeterol dry powder inhaler) treatment for 2 weeks
Drug: Salmeterol
Salmeterol 50 mcg (Serevent) via Diskus dry powder inhaler
Other Name: Serevent

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >=40 years
  • History of smoking >=20 pack-years of cigarettes
  • Be using medically acceptable birth-control measures if a female of child-bearing potential
  • Be willing to withhold any existing short or long-acting bronchodilators for the appropriate time period prior to each test day. Use of inhaled corticosteroids is not exclusionary, but will be maintained at a constant level throughout the study.
  • Must be willing and able to perform spirometry, slow vital capacity, plethysmography, DLCO, and 6 minute walk after appropriate instruction.
  • Informed consent
  • At the screening visit:

    • Post-albuterol FEV1/FVC <LLN (Hankinson)
    • Post-albuterol FEV1 <70%% and >=30 % predicted (Hankinson)
    • An increase in FEV1 after 4 puffs albuterol sulfate HFA of at least 5% and 50ml

Exclusion Criteria:

  • Presence of other clinically significant illnesses or condition that might interfere with the study, including but not limited to uncontrolled hypertension, cardiovascular disease, cardiac arrhythmia, diabetes, hyperthyroidism, seizure disorder or any history of pheochromocytoma
  • History of asthma (in the opinion of the investigator)
  • A COPD exacerbations within the past 2 months requiring oral corticosteroids or hospitalization.
  • Continuous oxygen therapy greater than 12 hours per day
  • Subjects with a body mass index less than 15 or greater than 38
  • Known allergy or contradiction to albuterol, arformoterol, salmeterol, tiotropium or prior significant adverse reactions to other beta agonists or ipratropium.
  • Hypersensitivity to milk protein. Bloating or gas from lactose is not an exclusion.
  • Inability to withhold other adrenergic drugs (salmeterol, arformoterol, formoterol, albuterol etc.) for an appropriate duration before each visit.
  • Ongoing need for drugs which might potentiate hypokalemia (xanthine derivatives (theophylline), steroids, non-potassium sparing diuretics (unless in fixed combination with potassium sparing diuretic)
  • Ongoing need for drugs which might cause QTc prolongation (MAO inhibitors, tricyclic antidepressants, cardiac anti-arrhythmics Class Ia (e.g., disopyramide, procainamide, quinidine), or class III (e.g., amiodarone, dofetilide, ibutilide, sotalol), terfenadine, astemizole, mizolastin and any other drug with potential to significantly prolong the QT interval.)
  • Ongoing need for beta-blockers (selective or non-selective)
  • Use of phenothizines (thioridizine), or other drugs that may interact with arformoterol, salmeterol or albuterol for the duration of the study. Washout of greater than seven half-lives of the drug prior to the study.
  • History of angle closure glaucoma, symptomatic prostatic hypertrophy or bladder neck obstruction.
  • Investigational drugs within 30 days
  • Affiliation with the Division of Pulmonary and Critical Care Medicine, David Geffen School of Medicine
  • Pregnancy, breastfeeding, planning to become pregnant during study, or woman of childbearing potential unwilling to use adequate contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361984

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Laura Menck, MA    310-825-3806    lmenck@mednet.ucla.edu   
Contact: Kyra Engelberg, MA    310-794-8665    kengelberg@mednet.ucla.edu   
Principal Investigator: Eric Kleerup, MD         
Sponsors and Collaborators
University of California, Los Angeles
Sunovion
  More Information

No publications provided

Responsible Party: Eric Kleerup, Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01361984     History of Changes
Other Study ID Numbers: Sunovion IC-HRCT
Study First Received: May 23, 2011
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Chronic Obstructive Pulmonary Disease
COPD
Emphysema
Chronic Bronchitis
Brovana
Serevent

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections
Salmeterol
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014