Polymorphism of beta2-adrenoceptor and Regular Use of Formoterol in Asthma

February 6, 2013 updated by: Leonello Fuso, Catholic University, Italy

Polymorphism of beta2-adrenoceptor and Regular Use of Formoterol in Asthma: Preliminary Results

Polymorphism at codon 16 of the beta2-adrenoceptor (beta2-AR) affects the responsiveness to salmeterol in asthmatics. Data concerning formoterol are more controversial in literature. The aim of this study was to verify whether homozygote for arginine-16 (ArgArg16) and homozygote for glycine-16 (GlyGly16) genotypes differently influence the long-term responsiveness to formoterol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Catholic University, Pneumology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pneumological outpatient clinic

Description

Inclusion Criteria:

  • Mild to moderate asthma
  • Stable clinical conditions

Exclusion Criteria:

  • Smokers
  • Current therapy with oral steroids
  • Exacerbations within the past 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Formoterol
12 mcg BID for four weeks
Drug: Formoterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak Expiratory Flow (PEF) variability
Time Frame: PEF has been monitorized during the 4-week treatment period
PEF has been monitorized during the 4-week treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Forced Expiratory Volume in 1 sec (FEV1) slope of the dose-response curve to salbutamol
Time Frame: At the end of the 4-week treatment period
At the end of the 4-week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSC-AG-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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