AsthmaNIKANCT01273363
Non-interventional Retrospective Multicenter Study of Patients With Bronchial Asthma During a Routine Visit to Out of Patients' Clinics
An observational study of Asthma, run by AstraZeneca at 12 sites in Russia.
Trial summary
To assess asthma control in Russian patients according to the new criteria provided in the international guidelines and identify pharmacological approaches that provide a higher level of overall asthma control Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 1,000 participants
- Where
- 12 sitesRussia
- Study dates
- Dec 2010to May 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical practice
Who may be able to join
- Male and female patients over 18 years of age
- Patients with asthma diagnosed in accordance with the Global Initiative for Asthma (GINA [xv]) within 6 months before inclusion into the study. Patients with no changes in their treatment within 2 months before inclusion into the study
- Patients who signed their informed consents to collection and further processing of data on their disease course
Who cannot join
- Asthma patients with an exacerbation at the moment of inclusion.
- Patients on β-blockers.
- Patients with COPD, mucoviscidosis or bronchiectasis, Severe heart failure (NYHA functional class III-IV), Renal insufficiency, Cancer, Previous stroke.
- Pregnant women.
- Patients following a major surgery, Hepatic insufficiency.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Russia12 sites
Research Site
Chelyabinsk
Research Site
Irkutsk
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
N.Novgorod
Research Site
Novosibirsk
Research Site
Perm
Research Site
Rostov-on-Don
Research Site
Saint Petersburg
Research Site
Ufa
Research Site
Yekaterinburg
About this study
To assess asthma control in Russian patients according to the new criteria provided in the international guidelines and identify pharmacological approaches that provide a higher level of overall asthma control
- Conditions
- Asthma
- Keywords
- Asthma, Asthma in Children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Male and female over 18. Patients with asthma diagnosed in accordance with the Global Initiative for Asthma within 6 months before inclusion into the study and without changes in treatment for 2 months before inclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess asthma control in Russian patients acc. to the new criteria in the international guidelines (Standardizing Endpoints for Clinical Asthma Trials and Clinical Practice) and identify pharmacological approaches provided a higher level of control
Measured: 1 visit for 3 month
Secondary outcomes (2)
To determine the main demographic, clinical and pharmacoepidemiological characteristics of low-control patients.
Measured: 1 visit for 3 month
To assess comparative value of the Asthma Control Questionnaire (ACT) and Asthma Control Questionnaire (ACQ) with regard to their use in clinical practice in Russia
Measured: 1 visit for 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionMay 2011
- Study completionMay 2011
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexey Stepanov, Prof., Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273363
- Sponsor's protocol ID
- NIS-RRU-DUM-2010/1
- Acronym
- NIKA
- Status last verified
- Feb 2012
- First submitted
- 7 Jan 2011
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Retrospective Multicenter Study of Patients With Bronchial Asthma During a Routine Visit to Out of Patients' Clinics
- ClinicalTrials.gov ID
- NCT01273363
- Acronym / sponsor ID
- NIKA / NIS-RRU-DUM-2010/1
- Conditions
- Asthma
- Keywords
- Asthma, Asthma in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Jan 2011 (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.
To assess asthma control in Russian patients according to the new criteria provided in the international guidelines and identify pharmacological approaches that provide a higher level of overall asthma control
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Male and female over 18. Patients with asthma diagnosed in accordance with the Global Initiative for Asthma within 6 months before inclusion into the study and without changes in treatment for 2 months before inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical practice
Key inclusion criteria (3 listed)
- Male and female patients over 18 years of age
- Patients with asthma diagnosed in accordance with the Global Initiative for Asthma (GINA [xv]) within 6 months before inclusion into the study. Patients with no changes in their treatment within 2 months before inclusion into the study
- Patients who signed their informed consents to collection and further processing of data on their disease course
Key exclusion criteria (5 listed)
- Asthma patients with an exacerbation at the moment of inclusion.
- Patients on β-blockers.
- Patients with COPD, mucoviscidosis or bronchiectasis, Severe heart failure (NYHA functional class III-IV), Renal insufficiency, Cancer, Previous stroke.
- Pregnant women.
- Patients following a major surgery, Hepatic insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess asthma control in Russian patients acc. to the new criteria in the international guidelines (Standardizing Endpoints for Clinical Asthma Trials and Clinical Practice) and identify pharmacological approaches provided a higher level of control
Time frame: 1 visit for 3 month
2 secondary outcomes
To determine the main demographic, clinical and pharmacoepidemiological characteristics of low-control patients.
Time frame: 1 visit for 3 month
To assess comparative value of the Asthma Control Questionnaire (ACT) and Asthma Control Questionnaire (ACQ) with regard to their use in clinical practice in Russia
Time frame: 1 visit for 3 month
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 28 Feb 2012.
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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.
Alexey Stepanov, Prof. study director
AstraZeneca
12 sites 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 AstraZeneca at 12 sites in Russia.
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 3 inclusion and 5 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 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Russia. 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?
To assess asthma control in Russian patients acc. to the new criteria in the international guidelines (Standardizing Endpoints for Clinical Asthma Trials and Clinical Practice) and identify pharmacological approaches provided a higher level of control (time frame: 1 visit for 3 month). 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 28 Feb 2012.