AsthmaPhase 3PASSIONNCT00628758
A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
A Phase 3 study testing Symbicort TBH - Turbuhaler and beta-II-agonist, inhale steroid in people with Asthma, run by AstraZeneca at 15 sites in Turkey (Türkiye).
Trial summary
The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Symbicort TBH - Turbuhaler and beta-II-agonist, inhale steroid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 15 sitesTurkey (Türkiye)
- Study dates
- Dec 2005to Sep 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required.
- Ability to read and write in Turkish
- Female or male outpatients aged 18 years
- Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition
- Prescribed inhaled glucocorticosteroid (GCS) at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1
- Either: daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA) or daily treatment with inhaled GCS alone (i.e. without LABA); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 Peak Expiratory Flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment
Who cannot join
- Previous treatment with Symbicort Single inhaler Therapy
- Use of any b-blocking agent, including eye drops
- Use of oral GCS as maintenance treatment
- Known or suspected hypersensitivity to study therapy or excipients
- A history of smoking 10 pack years
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
- Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Turkey (Türkiye)15 sites
Research Site
Ankara
Research Site
Antalya
Research Site
Bursa
Research Site
Denizli
Research Site
Diyarbakır
Research Site
Edirne
Research Site
Eski?ehir
Research Site
Istanbul
Research Site
Izmir
Research Site
Kocaeli
Research Site
Malatya
Research Site
Manisa
Research Site
Mersin
Research Site
Samsun
Research Site
Zonguldak
About this study
Official title: A Comparison of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5mg, 1 Inhalation Two Times a Day (b.i.d.) Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults a -26-week, Randomized, Open-label, Parallel-group, Multicentre Study
The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.
Read the detailed description
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.
- Conditions
- Asthma
- Being tested
- Symbicort TBH - Turbuhaler, beta-II-agonist, inhale steroid
- Keywords
- Symbicort, Turbuhaler, Persistent Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbicort TBH - TurbuhalerDrug
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
beta-II-agonist, inhale steroidDrug
Also called Astmerol inh 25 mcg/dosage, 60-120 dosage, Astmerol maksihaler 50 mcg/dosage, 28-60 dosage, Serevent diskus 50 mcg/dosage, 60 dosage, Serevent inh 25 mcg/dosage, 60 dosage
Salbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage
| Study group | Role | What they receive |
|---|---|---|
| Symbicort | Experimental | Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) Receives: Drug: Symbicort TBH - Turbuhaler |
| Conventional BP | Experimental | Conventional Best Practice for Treatment of Asthma Receives: Drug: beta-II-agonist, inhale steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Severe Asthma Exacerbation
Time to severe exacerbation among patients
Measured: 26 weeks
Secondary outcomes (3)
Number of Severe Asthma Exacerbations
Total number of severe asthma exacerbations per treatment group
Measured: 26 weeks
Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.
Measured: Baseline and 26 weeks
Mean Use of As-needed Medication Per Day During Treatment Period
Mean use of as-needed medication per day during treatment period
Measured: Daily recording during the treatment period of 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startDec 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zeynep Misirligil, Principal investigator, Ankara Univ. Med. Fac, Chest Disease Dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628758
- Sponsor's protocol ID
- D5890L00016
- Acronym
- PASSION
- Status last verified
- Jul 2012
- First submitted
- 10 Jan 2008
- Last updated
- 14 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5mg, 1 Inhalation Two Times a Day (b.i.d.) Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults a -26-week, Randomized, Open-label, Parallel-group, Multicentre Study
- ClinicalTrials.gov ID
- NCT00628758
- Acronym / sponsor ID
- PASSION / D5890L00016
- Conditions
- Asthma
- Keywords
- Symbicort, Turbuhaler, Persistent Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Posted 14 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.
Detailed description
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbicort | Experimental | Drug: Symbicort TBH - TurbuhalerSymbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) |
| Conventional BP | Experimental | Drug: beta-II-agonist, inhale steroidConventional Best Practice for Treatment of Asthma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required.
- Ability to read and write in Turkish
- Female or male outpatients aged 18 years
- Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition
- Prescribed inhaled glucocorticosteroid (GCS) at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1
Key exclusion criteria (7 listed)
- Previous treatment with Symbicort Single inhaler Therapy
- Use of any b-blocking agent, including eye drops
- Use of oral GCS as maintenance treatment
- Known or suspected hypersensitivity to study therapy or excipients
- A history of smoking 10 pack years
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 |
|---|---|---|
| Symbicort TBH - TurbuhalerSymbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) | Drug | Symbicort |
| beta-II-agonist, inhale steroidAlso: Astmerol inh 25 mcg/dosage, 60-120 dosage, Astmerol maksihaler 50 mcg/dosage, 28-60 dosage, Serevent diskus 50 mcg/dosage, 60 dosage, Serevent inh 25 mcg/dosage, 60 dosageSalbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage | Drug | Conventional BP |
Primary outcome
Time to First Severe Asthma Exacerbation
Time frame: 26 weeks
Time to severe exacerbation among patients
3 secondary outcomes
Number of Severe Asthma Exacerbations
Time frame: 26 weeks
Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
Time frame: Baseline and 26 weeks
Mean Use of As-needed Medication Per Day During Treatment Period
Time frame: Daily recording during the treatment period of 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Zeynep Misirligil principal investigator
Ankara Univ. Med. Fac, Chest Disease Dept
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Symbicort TBH - Turbuhaler and beta-II-agonist, inhale steroid in people with Asthma, run by AstraZeneca at 15 sites in Turkey (Türkiye).
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 6 inclusion and 7 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 14 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 15 sites in Turkey (Türkiye). 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to First Severe Asthma Exacerbation (time frame: 26 weeks). 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 14 Aug 2012.