Polymorphism of beta2-adrenoceptor and Regular Use of For... | NCT01786616

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

NCT01786616

Sponsor

Catholic University, Italy

Status

Completed

Last Update Posted

Feb 8, 2013Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Asthma

Interventions

Formoterol

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Apr 2010Actual

Completion Date

Not provided

First Submitted Date

Jan 29, 2013

First Submission Date that Met QC Criteria

Feb 6, 2013

First Posted Date

Feb 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2013

Last Update Posted Date

Feb 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Label	Type	Description	Intervention Names
Formoterol		12 mcg BID for four weeks	Drug: Formoterol

Name	Type	Description	Arm Group Labels	Other Names
Formoterol	Drug		Formoterol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild to moderate asthma
Stable clinical conditions

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Pneumological outpatient clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catholic University, Pneumology Unit		Rome		00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068759	Formoterol Fumarate

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided