NIS-observe Treatment Efficacy in Maintaining Symptoms Control in Moderate/Severe Asthma With Symbicort SMART

NCT ID: NCT00785733

Last Updated: 2010-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this non-interventional study is to evaluate efficacy of Symbicort® SMART treatment in adult patients with moderate to severe asthma using ACQ scores during 6 months period

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Moderate/Severe Asthma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Moderate and severe asthma patients stabilized on Symbicort SMART

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients eligible for entry into study are the patients diagnosed with moderate to severe asthma, that the doctors have already decided to treat with Symbicort SMART within the last month, before inclusion in this program
* All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.

Exclusion Criteria

* All the patients who have a known hypersensitivity to Symbicort or any of its excipients will not be included in this study.
* As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cristina Pentiuc

Role: STUDY_CHAIR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Alba Iulia, , Romania

Site Status

Research Site

Alexandria, , Romania

Site Status

Research Site

Arad, , Romania

Site Status

Research Site

Bacau, , Romania

Site Status

Research Site

Baia Mare, , Romania

Site Status

Research Site

Botoșani, , Romania

Site Status

Research Site

Brasov, , Romania

Site Status

Research Site

Brăila, , Romania

Site Status

Research Site

Breaza, , Romania

Site Status

Research Site

Bucharest, , Romania

Site Status

Research Site

Buftea, , Romania

Site Status

Research Site

Campulung Muscel, , Romania

Site Status

Research Site

Câmpina, , Romania

Site Status

Research Site

Călăraşi, , Romania

Site Status

Research Site

Cluj-Napoca, , Romania

Site Status

Research Site

Constanța, , Romania

Site Status

Research Site

Craiova, , Romania

Site Status

Research Site

Deva, , Romania

Site Status

Research Site

Drobeta-Turnu Severin, , Romania

Site Status

Research Site

Giurgiu, , Romania

Site Status

Research Site

Hunedoara, , Romania

Site Status

Research Site

Iași, , Romania

Site Status

Research Site

Leordeni, , Romania

Site Status

Research Site

Miercurea-Ciuc, , Romania

Site Status

Research Site

Mizil, , Romania

Site Status

Research Site

Oradea, , Romania

Site Status

Research Site

Palazu Mare, , Romania

Site Status

Research Site

Piatra Neamţ, , Romania

Site Status

Research Site

Piteşti, , Romania

Site Status

Research Site

Ploieşti, , Romania

Site Status

Research Site

Reşiţa, , Romania

Site Status

Research Site

Rm. Valcea, , Romania

Site Status

Research Site

Scorniceşti, , Romania

Site Status

Research Site

Sf. Gheorghe, , Romania

Site Status

Research Site

Sibiu, , Romania

Site Status

Research Site

Slobozia, , Romania

Site Status

Research Site

Suceava, , Romania

Site Status

Research Site

Târgovişte, , Romania

Site Status

Research Site

Târgu Mureş, , Romania

Site Status

Research Site

Tg. Jiu, , Romania

Site Status

Research Site

Timișoara, , Romania

Site Status

Research Site

Tulcea, , Romania

Site Status

Research Site

Vaslui, , Romania

Site Status

Research Site

Zalău, , Romania

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Romania

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIS-RRO-SYM-2008/1

Identifier Type: -

Identifier Source: org_study_id