NCT01786616

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

5.2 years

First QC Date

January 29, 2013

Last Update Submit

February 6, 2013

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Peak Expiratory Flow (PEF) variability

    PEF has been monitorized during the 4-week treatment period

Secondary Outcomes (1)

  • Forced Expiratory Volume in 1 sec (FEV1) slope of the dose-response curve to salbutamol

    At the end of the 4-week treatment period

Study Arms (1)

Formoterol

12 mcg BID for four weeks

Drug: Formoterol

Interventions

FormoterolDRUG
Formoterol

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pneumological outpatient clinic

You may qualify if:

  • Mild to moderate asthma
  • Stable clinical conditions

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University, Pneumology Unit

Rome, 00168, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

white cells

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 8, 2013

Study Start

January 1, 2005

Primary Completion

April 1, 2010

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

IT(1)