Allergic AsthmaNCT00421018
Optimization of Asthma Treatment Through Exhaled NO for Increased Asthma-Related Quality of Life (NOAK)
A study testing Single corticosteroid inhalers and Singulair in people with Allergic Asthma, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in patients with allergic asthma Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Single corticosteroid inhalers and Singulair
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2006to Apr 2010
- Phase
- Interventional
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-64
- Clinical diagnosis of Asthma
- Glucocorticoid treatment > 6 months.
- Verified Allergy
- Read and speak Swedish
Who cannot join
- Smoking
- Current regular treatment with long-acting beta2-agonist
- Treatment with Singulair only or in combination with glucocorticoids
- Taking part in other research study
- Pregnancy or breast-feeding
- Unstable Asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of the Anti-Inflammatory Treatment of Asthma Patients Through Exhaled NO Measurements for Increased Asthma-Related Quality of Life in Primary Health Care (NOAK)
The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in patients with allergic asthma
- Conditions
- Allergic Asthma
- Being tested
- Single corticosteroid inhalers and Singulair
- Keywords
- Asthma, Allergy, Cytokines, Glucocorticoids, Inflammation, Nitric Oxide (NO), Quality of Life, Self-Rated Health, Stress
- Medical subject headings
- Asthma, Hypersensitivity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single corticosteroid inhalers and SingulairDrug
Treatment steps according to preset algorithm
| Study group | Role | What they receive |
|---|---|---|
| Symptom-guided group | Sham comparator | Anti-inflammatory treatment is guided conventionally according to symptoms and beta-2-agonist use. Receives: Drug: Single corticosteroid inhalers and Singulair |
| FeNO-guided group | Active comparator | Anti-inflammatory treatment is guided according to the level of exhaled nitric oxide Receives: Drug: Single corticosteroid inhalers and Singulair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-AQLQ (Asthma-Related Quality of Life)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Aerocrine AB, Phadia AB, Meda AB, The Swedish Research Council, Swedish Council for Working Life and Social Research, Merck Sharp & Dohme LLC, Uppsala University
- Investigators
- Kjell Alving, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421018
- Sponsor's protocol ID
- 20050166
- Status last verified
- Aug 2012
- First submitted
- 10 Jan 2007
- Last updated
- 15 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Anti-Inflammatory Treatment of Asthma Patients Through Exhaled NO Measurements for Increased Asthma-Related Quality of Life in Primary Health Care (NOAK)
- ClinicalTrials.gov ID
- NCT00421018
- Acronym / sponsor ID
- 20050166
- Conditions
- Allergic Asthma
- Keywords
- Asthma, Allergy, Cytokines, Glucocorticoids, Inflammation, Nitric Oxide (NO), Quality of Life, Self-Rated Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Aerocrine AB, Phadia AB, Meda AB, The Swedish Research Council, Swedish Council for Working Life and Social Research, Merck Sharp & Dohme LLC, Uppsala University
- Study start
- Nov 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 11 Jan 2007 (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.
The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in patients with allergic asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom-guided group | Sham comparator | Drug: Single corticosteroid inhalers and SingulairAnti-inflammatory treatment is guided conventionally according to symptoms and beta-2-agonist use. |
| FeNO-guided group | Active comparator | Drug: Single corticosteroid inhalers and SingulairAnti-inflammatory treatment is guided according to the level of exhaled nitric oxide |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-64
- Clinical diagnosis of Asthma
- Glucocorticoid treatment > 6 months.
- Verified Allergy
- Read and speak Swedish
Key exclusion criteria (6 listed)
- Smoking
- Current regular treatment with long-acting beta2-agonist
- Treatment with Singulair only or in combination with glucocorticoids
- Taking part in other research study
- Pregnancy or breast-feeding
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 |
|---|---|---|
| Single corticosteroid inhalers and SingulairTreatment steps according to preset algorithm | Drug | FeNO-guided group, Symptom-guided group |
Primary outcome
Mini-AQLQ (Asthma-Related Quality of Life)
Time frame: 1 year
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 15 Aug 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.
Kjell Alving, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single corticosteroid inhalers and Singulair in people with Allergic Asthma, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 6 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 15 Aug 2012. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
Mini-AQLQ (Asthma-Related Quality of Life) (time frame: 1 year). 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 15 Aug 2012.