Initial Study of Fenoterol as a Treatment for Heart Failure

NCT01440335 | Completed Phase 1

• 2 other identifiers: 99991115311-AG-N153
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Fenoterol has been used to treat asthma by opening up the airways in the lungs. It also increases the heart rate without significantly increasing blood pressure. This means that it may help improve heart function by boosting the heart's output. Researchers have developed a different form of the drug that may be given to individuals with heart trouble. This new form needs more testing. It is especially important to compare the new form with the original form of the drug used to treat asthma. Objectives: \- To compare how safe and effective two different forms of Fenoterol are in improving heart function. Eligibility: \- Healthy people between 21 and 60 years of age who have no history of heart disease. Design:

• People will be screened with a medical history, physical exam, blood and urine tests, and heart function studies.
• Those in the study will have two 36-hour inpatient study visits. At each visit, they will have a physical exam and blood and urine tests. They will fast overnight and then receive one of the two forms of Fenoterol first thing in the morning. They will not know whether they are getting the original or the modified form of the drug. After receiving the drug, they will provide frequent blood and urine samples for 24 hours. They will have a final exam before being discharged.
• Those who take part in the study will have a followup visit 5 to 7 days after the end of each study visit. They will provide more blood and urine samples and have a physical exam.

Conditions

Congestive Heart Failure

Keywords

Fenoterol; Pharmacodynamics; Pharmacokinetics; Safety; Beta Adrenergic Agonist

Outcome Measures

Primary Outcomes (3)

• Safety assessment

• Pharmacokinetics

• Bioavailability

Secondary Outcomes (4)

• Pharmacodynamic effects of heart rate

• Blood Pressure

• Echocardiographic indices of cardiac structure and function

• B2-AR lymphocyte binding and function during drug exposure

Interventions

Oral R,R'-Fenoterol DRUG

Oral Racemic Fenoterol DRUG

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• Age: 21-60
• Screening laboratory evaluations with no clinically significant abnormal results:
• Chem-20 panel plus troponin
• Complete blood count with differential and platelet count
• Urinalysis with microscopic examination
• Electrocardiogram
• Echocardiogram: 2D + Doppler
• Urine drug screen
• Urine pregnancy test
• BMI 24-30
• Able to provide written informed consent
• Agree to not participate in other clinical trials during the study period
• If in child-bearing age and participating in sexual activity that could lead to pregnancy, agree to use a medically accepted method of contraception for a woman for at least 1 month prior to enrollment and continuing 1 month after completion of the fifth study visit, and for a man beginning immediately after the second study visit and continuing for 3 months after completion of the fifth study visit.

You may not qualify if:

• Resting sitting blood pressure greater than 140/90 mm Hg, resting heart rate greater than 100 bpm
• Clinically significant abnormality on EKG (major Q waves, evidence of heart block, significant conduction disease, QT prolongation)
• Clinically significant abnormality on Echocardiogram (ejection fraction less than 50 percent, valvular heart disease of moderate severity, pulmonary hypertension with PASP greater than 40mm Hg)
• Evidence of illicit drug use or alcohol abuse
• History of Human Immunodeficiency Virus (HIV) infection
• History of active or chronic Hepatitis B and/or C infection
• History of malignancy (other than non-invasive skin cancer)
• History of coronary disease, conduction system disease, pacemaker, atrial fibrillation/flutter, ventricular tachycardia/fibrillation, significant valvular disease, or other cardiovascular disease
• History of asthma -- reactive airway disease
• History of seizures or other neurologic diseases
• History of liver or renal diseases
• History of gastrointestinal or endocrine disorders (other than mild dyspepsia)
• Medication use other than occasional use of over-the-counter drugs and/or contraceptives
• Any medication or herbal drug use within the past 3 days before study participation other than contraceptives
• Any medical history that, in the opinion of the investigator(s), will make participation of the subject in the study unsafe

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• Wilson AA, Wang J, Koch P, Walle T. Stereoselective sulphate conjugation of fenoterol by human phenolsulphotransferases. Xenobiotica. 1997 Nov;27(11):1147-54. doi: 10.1080/004982597239903.

  PMID: 9413918 BACKGROUND

• Ahmet I, Krawczyk M, Heller P, Moon C, Lakatta EG, Talan MI. Beneficial effects of chronic pharmacological manipulation of beta-adrenoreceptor subtype signaling in rodent dilated ischemic cardiomyopathy. Circulation. 2004 Aug 31;110(9):1083-90. doi: 10.1161/01.CIR.0000139844.15045.F9. Epub 2004 Aug 16.

  PMID: 15313944 BACKGROUND

• Anderson G, Wilkins E, Jariwalla AG. Fenoterol in asthma. Br J Dis Chest. 1979 Jan;73(1):81-4.

  PMID: 373786 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• James B Strait, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: September 26, 2011
• Study Start: July 10, 2011
• Primary Completion: April 15, 2014
• Study Completion: April 15, 2014
• Last Updated: July 5, 2018

Record last verified: 2015-01-07

Locations

US (1)