Sunovion Brovana Versus Serevent Inspiratory Capacity High Resolution Computed Tomography
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|ClinicalTrials.gov Identifier: NCT01361984|
Recruitment Status : Unknown
Verified July 2012 by Eric Kleerup, University of California, Los Angeles.
Recruitment status was: Recruiting
First Posted : May 27, 2011
Last Update Posted : July 20, 2012
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease COPD Emphysema Chronic Bronchitis||Drug: Nebulized arformoterol Drug: Salmeterol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Inspiratory Capacity and HRCT Comparison of Nebulized Arformoterol (Brovana) vs. Dry-powder Inhaler Salmeterol (Serevent)|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
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
Salmeterol 50 mcg (Serevent) via Diskus dry powder inhaler
Other Name: Serevent
- Inspiratory capacity (absolute volume BTPS, L) [ Time Frame: Week 4 ]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).
- Inspiratory capacity (absolute change, % change, %predicted change) [ Time Frame: Week 4 ]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 ]Inspiratory capacity as percent of reference total lung capacity
- Other breathing test outcomes [ Time Frame: Week 4 ]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
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|Ages Eligible for Study:||40 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361984
|United States, California|
|Los Angeles, California, United States, 90095|
|Contact: Laura Menck, MA 310-825-3806 email@example.com|
|Contact: Kyra Engelberg, MA 310-794-8665 firstname.lastname@example.org|
|Principal Investigator: Eric Kleerup, MD|
|Responsible Party:||Eric Kleerup, Clinical Professor, University of California, Los Angeles|
|Other Study ID Numbers:||
|First Posted:||May 27, 2011 Key Record Dates|
|Last Update Posted:||July 20, 2012|
|Last Verified:||July 2012|
Chronic Obstructive Pulmonary Disease
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action