AsthmaNCT01786616
Polymorphism of beta2-adrenoceptor and Regular Use of Formoterol in Asthma
An observational study of Asthma, run by Catholic University, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Formoterol
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2005to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Pneumological outpatient clinic
Who may be able to join
- Mild to moderate asthma
- Stable clinical conditions
Who cannot join
- Smokers
- Current therapy with oral steroids
- Exacerbations within the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- Formoterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormoterolDrug
| Study group | Role | What they receive |
|---|---|---|
| Formoterol | 12 mcg BID for four weeks Receives: Drug: Formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Expiratory Flow (PEF) variability
Measured: 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
Measured: At the end of the 4-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJan 2005
- Primary completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonello Fuso, Catholic University, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786616
- Sponsor's protocol ID
- UCSC-AG-16
- Status last verified
- Feb 2013
- First submitted
- 29 Jan 2013
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphism of beta2-adrenoceptor and Regular Use of Formoterol in Asthma: Preliminary Results
- ClinicalTrials.gov ID
- NCT01786616
- Acronym / sponsor ID
- UCSC-AG-16
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Catholic University, ItalyUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Apr 2010 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Formoterol | – | Drug: Formoterol12 mcg BID for four weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pneumological outpatient clinic
Key inclusion criteria (2 listed)
- Mild to moderate asthma
- Stable clinical conditions
Key exclusion criteria (3 listed)
- Smokers
- Current therapy with oral steroids
- Exacerbations within the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formoterol | Drug | Formoterol |
Primary outcome
Peak Expiratory Flow (PEF) variability
Time frame: PEF has been monitorized during the 4-week treatment period
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Catholic University, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Expiratory Flow (PEF) variability (time frame: PEF has been monitorized during the 4-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2013.