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Protocol Summary for 114520

Protocol Summary
Protocol Id:	114520
Secondary Ids:
Title:	Effects of bronchodilatation with salmeterol on the autonomic nervous system
Phase:	phase 4
Acronym:	ESAN
FDA Regulated Intervention?:	No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Collaborators:	N/A
Brief Summary:	This is a 4-week non-randomized, partially blinded, single-arm monocentre study in subjects with Chronic Obstructive Pulmonary Disease (COPD) Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II or III with the aim to demonstrate that inhaled therapy with salmeterol reduces sympathetic activity as evaluated by microneurography. A maximum of 32 subjects is planned to be enrolled.
Detailed Description:	This is a 4-week non-randomized, partially blinded, single-arm monocentre study in subjects with COPD GOLD class II or III with the aim to demonstrate that inhaled therapy with salmeterol reduces sympathetic activity as evaluated by microneurography. A maximum of 32 subjects is planned to be enrolled. During a complex data registration period comprising the continuous recording of muscle sympathetic nerve activity (MSNA) and respiration and of various other measurements at Visit 1, placebo and 50 μg of salmeterol via Diskus™ inhaler will be administered in a sequential design. Following Visit 1, the subjects will be treated with salmeterol 50 μg twice daily via Diskus inhaler for 4 weeks. At the Final Visit (Visit 2) the data registration period of Visit 1 will be repeated with the only difference that no placebo will be administered. Further endpoints, besides the evaluation of MSNA, include heart rate variability (HRV), spontaneous baroreflex sensitivity and lung function parameters. Study enrolment will be stopped when valid MSNA data on the immediate effect of inhalation (manoeuvres at Visit 1) are available for 24 subjects.
Record Verification Date:	January 2013
Status:	Completed
Why Study Stopped:
Study Start Date:	July 2012
Study Completion Date:	November 2012
Study Completion Date Type:	Actual
Primary Completion Date:	November 2012
Primary Completion Date Type:	Actual
Primary Purpose:	treatment
Allocation:	N\A
Masking:	Single Blind
Masked Subject:	yes
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Single Group Assignment
Study Classification (Endpoint):	Efficacy Study
Primary Outcomes:	Change in Muscle Sympathetic Nerve Activity (MSNA) yes baseline and 2 hours
Secondary Outcomes:	Change in Heart Rate Variability (HRV) baseline and 4 weeks Change in Muscle Sympathetic Nerve Activity (MSNA) baseline and 4 weeks Change in vital capacity (VC) baseline and 4 weeks Change in Brain Natriuretic Peptide (BNP) baseline and 4 weeks Change in functional residual capacity (FRC) baseline and 4 weeks Change in epinephrine baseline and 4 weeks Change in forced expiratory volume in one second (FEV1) baseline and 4 weeks Change in residual volume (RV) baseline and 4 weeks Change in arterial stiffness baseline and 4 weeks Change in norepinephrine baseline and 4 weeks Change in total lung capacity (TLC) baseline and 4 weeks Change in spontaneous baroreflex sensitivity baseline and 4 weeks
Conditions:	Pulmonary Disease, Chronic Obstructive
Keywords:	influence of bronchodilatation with salmeterol on the autonomic nervous systems in COPD patients will be measured using MSNA. Relation of COPD and sympathetic nerve activity is to be evaluated,
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: • COPD of GOLD Class II or III with a post-bronchodilator spirometry forced expiratory volume in one second (FEV1) <60% predicted and FEV1/vital capacity (VC) <70% in accordance with the GOLD executive summary • Subject is ambulatory (outpatient) • Subject is therapy-naive (defined as not receiving any previous regular COPD therapy) • Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening Visit. Previous smokers are defined as those who have stopped smoking for at least 1 month prior to Visit 1 • Willing to participate in the study, must be able to inhale study medication Exclusion Criteria: • Women who are pregnant or lactating • Subjects not willing or unable to sign the informed consent before study start • diagnosis of asthma • α-1 antitrypsin deficiency • active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases • Subjects with lung volume reduction surgery within the 12 months prior to Screening • Subjects who have been hospitalized due to poorly controlled COPD within 6 weeks prior to the Screening Visit • Subjects with poorly controlled COPD, defined as the occurrence of an exacerbation managed with systemic corticosteroids or antibiotics prescribed by a physician 6 weeks prior to the Screening Visit • Frequent exacerbations necessitating the therapy with inhaled glucocorticosteroids according to the GOLD guideline • COPD with nasal intermittent positive pressure ventilation (NIPPV) • Treatment with drugs having direct sympathomimetic activity (e.g. theophylline, moxonidine, clonidine), Oral medication with beta2-sympathomimetics • Inhaled therapy with anti-cholinergics, sodium cromoglycate or nedocromil sodium • Treatment with systemic, oral or parenteral (intra-articular) corticosteroids • Treatment with strong cytochrome P450 3A4 inhibitors • Treatment with any other investigational drug • Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day • Subjects who are medically unable to withhold their short-acting beta-agonist (SABA) for the 6-hour period required prior to spirometry testing at each study visit • Subjects with clinically significant sleep apnoea that is uncontrolled • Unstable angina pectoris or signs and history of left heart failure with a left ventricular ejection fraction <40% • Arterial hypertension necessitating treatment with >1 antihypertensive drug • Clinically evident polyneuropathy • Diabetes mellitus necessitating any pharmacological therapy • Severe concomitant disease (likely to reduce life expectancy to less than 3 years) • Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant neurological, psychiatric, renal, hepatic, immunological, endocrine or haematological abnormality that is uncontrolled
Gender:	Both
Minimum Age:	41 Year
Maximum Age:	79 Year
Enrollment:	34
Enrollment Type:	Actual
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Germany (click to view all sites in Germany) GSK Investigational Site Goettingen, Niedersachsen, 37075; COMPLETED; Contact: Stefan Andreas, Principal Investigator, .

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Protocol Summary for 114520