Effects of bronchodilatation with salmeterol on the autonomic nervous system

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-001581-18-DE
• Lead Sponsor: GlaxoSmithKline GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-07
• Last Update Posted: 21 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product that may impact subject eligibility is provided in the current Prescribing Information for Serevent® Diskus® (50 µg). Subjects eligible for enrolment in the study must meet all of the following criteria:
1. Subjects with COPD of GOLD Class II or III with a post-bronchodilator spirometry
forced expiratory volume in one second (FEV1) <70% predicted and FEV1/vital capacity (VC) <70% in accordance with the GOLD executive summary [Rabe, 2007]. Post-bronchodilator spirometry will be performed approximately 10-15
minutes after the subject has self-administered a SABA (fenoterol or salbutamol per inhalation).
2.Male or female subjects, aged > 40 and < 80 years. Females of non child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile), and women of child bearing potential with a negative pregnancy test at Screening who agree to use consistently and correctly a highly effective contraceptive method may be included.
3.Subject is ambulatory (outpatient).
4.Subjects using inhaled therapy have to abstain from their medication prior to visit 1 (time interval per medication see table 1).
5.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.
6. Subjects willing and able to sign the informed consent before study start.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in the study (for detailed information on prohibited medications see also Protocol page 22, Table 1):
1.Women who are pregnant or lactating.
2.Subjects not willing or unable to sign the informed consent before study start.
3.Subjects with a current diagnosis of asthma.
4.Subjects with a-1 antitrypsin deficiency as the underlying cause of COPD.
5.Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
6.Subjects with lung volume reduction surgery within the 12 months prior to Screening.
7.Subjects who have been hospitalized due to poorly controlled COPD within 6 weeks prior to the Screening Visit.
8.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.
9.Frequent exacerbations necessitating the therapy with inhaled glucocorticosteroids according to the GOLD guideline.
10.COPD with nasal intermittent positive pressure ventilation (NIPPV).
11.Treatment with drugs having direct sympathomimetic activity (e.g. theophylline, moxonidine, clonidine).
12.Oral medication with beta2-sympathomimetics.
13.Inhaled therapy with sodium cromoglycate or nedocromil sodium.
14.Treatment with systemic, oral or parenteral (intra-articular) corticosteroids.
15.Treatment with strong cytochrome P450 3A4 inhibitors.
16.Treatment with any other investigational drug.
17.Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen use = 12 hours per day is not exclusionary.
18.Medication prior to spirometry: Subjects who are medically unable to withhold their SABA for the 6-hour period required prior to spirometry testing at each study visit.
19.Subjects with clinically significant sleep apnoea that is uncontrolled.
20.Unstable angina pectoris or signs and history of left heart failure with a left ventricular ejection fraction < 40%.
21.Arterial hypertension necessitating treatment with > 3 antihypertensive drugs.
22.Clinically evident polyneuropathy.
23.Diabetes mellitus necessitating any insulin therapy.
24.Severe concomitant disease (likely to reduce life expectancy to less than 3 years).
25.Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant neurological, psychiatric, renal, hepatic, immunological, endocrine or haematological abnormality that is uncontrolled.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified