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NCT01786616 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01786616
Other study ID # UCSC-AG-16
Secondary ID
Status Completed
Phase N/A
First received January 29, 2013
Last updated February 6, 2013
Start date January 2005

Study information
Verified date February 2013
Source Catholic University, Italy
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Mild to moderate asthma

- Stable clinical conditions

Exclusion Criteria:

- Smokers

- Current therapy with oral steroids

- Exacerbations within the past 3 months

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Formoterol

Locations
Country Name City State
Italy Catholic University, Pneumology Unit Rome

Sponsors (1)
Lead Sponsor Collaborator
Catholic University, Italy

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peak Expiratory Flow (PEF) variability PEF has been monitorized during the 4-week treatment period No
Secondary Forced Expiratory Volume in 1 sec (FEV1) slope of the dose-response curve to salbutamol At the end of the 4-week treatment period No
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