Official Title: “Evaluation of β2 Genetic Polymorphisms and the Effect of Albuterol Inhalation on Potassium and Glucose Plasma Concentration”

Several studies have indicated that albuterol administered either intravenously or by inhalation can significantly reduce plasma potassium concentration in patients suffering from chronic renal failure.In conjunction with the decrease in potassium concentration a modest rise in glucose concentration is usually noted. These metabolic effects are characterized by rapid onset occurring as early as 3-5 minutes following salbutamol administration and lasting for at least 1 hour.

The role played by ß2AR polymorphisms in determining the bronchial and vascular response to ß2AR agonist drugs, have been confirmed by several studies.

The purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2AR and the metabolic effects of inhaled albuterol.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Intervention(s) in this Clinical Trial

• Drug: Albuterol (1,200 μg) through metered-dose inhaler

Primary Measures

• The extent of decrease in plasma potassium concentration
• The extent of increase in plasma glucose concentration
• Plasma concentration of albuterol

Inclusion Criteria:

• patients regularly attending the nephrological clinic or the dialysis unit
• persistent potassium concentration above 5 mEq/L

Exclusion Criteria:

• 1. Patients suffering from active ischemic heart disease
• 2. Patient with a recent history of arrhythmia
• 3. Patients treated regularly with ß blockers
• 4. Patients treated regularly with salbutamol or other ß2AR agonists
• 5. Patients suffering from persistent tachycardia (pulse > 100 beats/min)
• 6. Patients who are hemodynamically unstable
• 7. Patients suffering from any acute illness

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hadassah Medical Organization

Overall Clinical Trial Officials and Contacts

Yoseph Caraco, MD Principal Investigator Hadassah Medical Organization  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00162487

Study ID Number: yc19556-HMO-CTIL

ClinicalTrials.gov Identifier: NCT00162487

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration