AsthmaPhase 34ANCT00986323
Efficacy Study of Temperature Controlled Laminar Airflow (TLA)-Treatment in Perennial Allergic Asthma
A Phase 3 study of Asthma, run by Airsonett AB at 19 sites in 6 countries.
Trial summary
The purpose of this study is to determine whether nocturnal environmental control with Temperature controlled Laminar Airflow (TLA) is effective as add on treatment in patients with perennial allergic asthma. Read more about this study
- Who is it for?
- Ages 7 to 70 years
- Conditions the study is for
- Asthma
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 19 sitesin 6 countries
- Study dates
- Apr 2008to Feb 2010
- Phase
- Phase 3
- 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 7 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consent to participate voluntarily. Willing and able to comply with the study specific procedures. Signed Informed Consent prior to any study procedure.
- Perennial allergic asthma, male and female, age 7 through 70 years, at time of randomization.
- A miniAQLQ/PAQLQ score of ≤ 5.5.
- Sensitive to pet allergen and/or house dust mites as demonstrated by changed to RAST 0.70 or positive skin prick test (wheal reaction similar to histamine control).
- Daily maintenance dose of at least ICS ≥200µg/day of budesonide or ≥100µg/day of fluticasone since at least 6 months
- Features of partly controlled asthma according to GINA
Who cannot join
- Current smoker (Non-smoker is defined as abstinent since > 1 year). Children: Parents'indoor smoking.
- Participation in another allergen avoidance program
- Participation in drug trial the preceding 3 months
- Multiple chemical sensitivity (e.g. paint, petrol, perfumes) as primary etiology
- Allergen injection or sublingual treatment in the preceding 2 years
- ICS ≥1200µg/day of budesonide or 1000µg/day of fluticasone
Show all 9Show fewer
- Significant cardiovascular disease
- Participation in the present trial of a family member within the same household
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
Sweden9 sites
Ängelholm Hospital
Ängelholm
Sahlgrenska University Hospital, Sweden
Gothenburg
Jonkoping County Hospital
Jönköping
County Council of Värmland
Karlstad
University Hospital, Linkoeping
Linköping
Lund University Hospital
Lund
Karolinska University Hospital
Stockholm, SE-171 76
S:t Görans Hospital, Sweden
Stockholm
Stockholm South General Hospital
Stockholm
Germany4 sites
Ruhr University of Bochum
Bochum
University of München
München
University of Rostock
Rostock
Marien Hospital Wesel
Wesel
Denmark2 sites
Aarhus University Hospital
Aarhus
Bispebjerg Hospital
Copenhagen
About this study
Official title: Airsonett Airshower in Allergic Asthma a Double-blind Randomized Multi-centre Trial
The purpose of this study is to determine whether nocturnal environmental control with Temperature controlled Laminar Airflow (TLA) is effective as add on treatment in patients with perennial allergic asthma.
Read the detailed description
Exposure to inhaled allergens is a pathogenetic factor in allergic asthma. However, physical, chemical and combined methods aiming to reduce airborne allergen levels have shown little or no effect in reducing asthma symptoms in people who are sensitive to perennial allergens.Aims and objectives: This study aims to investigate treatment with Temperature controled Laminar Airflow (TLA) with a very low particle concentration directed to the breathing zone in subjects with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have an effect on quality of life and bronchial inflammation.
Method: This is a multicentre, double blind, randomized 52 week parallel trial comparing active TLA treatment with Placebo. For ethical reasons the randomization is 2 to 1 for active and placebo treatment, respectively. A 2 weeks run-in period is inserted between inclusion and randomization, during which the patient shall get familiar with the use of the patient asthma diary and to adhere to the requirements of the study participation. First 12 weeks an unchanged maintenance medication will be kept and week 13-52 medication will be modified to obtain asthma control according to international guidelines (GINA). After inclusion, run-in, randomization and baseline measurements active/placebo treatment with AA will be implemented over 52 weeks.
- Conditions
- Asthma
- Being tested
- Temperature controlled Laminar Airflow (TLA), Placebo TLA
- Keywords
- Asthma, Temperature controlled Laminar Airflow, TLA, Perennial allergy, Quality of life, Environmental control
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature controlled Laminar Airflow (TLA)Device
Also called Protexo, TLA
Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA).
Placebo TLADevice
Placebo TLA (without filtration and TLA function)
| Study group | Role | What they receive |
|---|---|---|
| Temeperature controlled Laminar Airflow | Active comparator | Active treatment with Temperature controlled Laminar Airflow (TLA) Receives: Device: Temperature controlled Laminar Airflow (TLA) |
| Placebo TLA | Placebo comparator | Placebo TLA treatment Receives: Device: Placebo TLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score.
Measured: Week -2, 0, 4, 12, 24, 36 and 52
Secondary outcomes (6)
FENO (Nitric Oxide in Exhaled Air)
Measured: Week -2, 0, 4, 12, 24, 36 and 52
Lung function assessed by forced expiratory volume (FEV1), PEF (Expiratory peak flow) and FEF50 (Predicted Forced Expiratory Flow Rate at 50 Percent of Vital Capacity)
Measured: Week -2, 0, 4, 12, 24, 36 and 52
Rhinitis symptoms assessed by questionnaire
Measured: Week 0 and 52
RAST value and eosinophil count.
Measured: Week 0 and 52
Asthma Control Test (ACT).
Measured: Week -2, 0, 12, 24, 36 and 52
Resource consumption
Measured: Week 0, 4, 12, 24, 36 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startApr 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Airsonett AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Commitum AB, Croel AB
- Investigators
- Olof Zetterström, MD, PhD., Principal investigator, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986323
- Sponsor's protocol ID
- Air 3-03
- Acronym
- 4A
- Status last verified
- Nov 2010
- First submitted
- 27 Sep 2009
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boyle RJ, Pedroletti C, Wickman M, Bjermer L, Valovirta E, Dahl R, Von Berg A, Zetterstrom O, Warner JO; 4A Study Group. Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial. Thorax. 2012 Mar;67(3):215-21. doi: 10.1136/thoraxjnl-2011-200665. Epub 2011 Nov 30.
PubMed 22131290
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airsonett Airshower in Allergic Asthma a Double-blind Randomized Multi-centre Trial
- ClinicalTrials.gov ID
- NCT00986323
- Acronym / sponsor ID
- 4A / Air 3-03
- Conditions
- Asthma
- Keywords
- Asthma, Temperature controlled Laminar Airflow, TLA, Perennial allergy, Quality of life, Environmental control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Airsonett ABIndustry (pharma, biotech, devices)
- Collaborators
- Commitum AB, Croel AB
- Study start
- Apr 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Sep 2009 (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 nocturnal environmental control with Temperature controlled Laminar Airflow (TLA) is effective as add on treatment in patients with perennial allergic asthma.
Detailed description
Exposure to inhaled allergens is a pathogenetic factor in allergic asthma. However, physical, chemical and combined methods aiming to reduce airborne allergen levels have shown little or no effect in reducing asthma symptoms in people who are sensitive to perennial allergens.Aims and objectives: This study aims to investigate treatment with Temperature controled Laminar Airflow (TLA) with a very low particle concentration directed to the breathing zone in subjects with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have an effect on quality of life and bronchial inflammation.
Method: This is a multicentre, double blind, randomized 52 week parallel trial comparing active TLA treatment with Placebo. For ethical reasons the randomization is 2 to 1 for active and placebo treatment, respectively. A 2 weeks run-in period is inserted between inclusion and randomization, during which the patient shall get familiar with the use of the patient asthma diary and to adhere to the requirements of the study participation. First 12 weeks an unchanged maintenance medication will be kept and week 13-52 medication will be modified to obtain asthma control according to international guidelines (GINA). After inclusion, run-in, randomization and baseline measurements active/placebo treatment with AA will be implemented over 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temeperature controlled Laminar Airflow | Active comparator | Device: Temperature controlled Laminar Airflow (TLA)Active treatment with Temperature controlled Laminar Airflow (TLA) |
| Placebo TLA | Placebo comparator | Device: Placebo TLAPlacebo TLA treatment |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Consent to participate voluntarily. Willing and able to comply with the study specific procedures. Signed Informed Consent prior to any study procedure.
- Perennial allergic asthma, male and female, age 7 through 70 years, at time of randomization.
- A miniAQLQ/PAQLQ score of ≤ 5.5.
- Sensitive to pet allergen and/or house dust mites as demonstrated by changed to RAST 0.70 or positive skin prick test (wheal reaction similar to histamine control).
- Daily maintenance dose of at least ICS ≥200µg/day of budesonide or ≥100µg/day of fluticasone since at least 6 months
Key exclusion criteria (9 listed)
- Current smoker (Non-smoker is defined as abstinent since > 1 year). Children: Parents'indoor smoking.
- Participation in another allergen avoidance program
- Participation in drug trial the preceding 3 months
- Multiple chemical sensitivity (e.g. paint, petrol, perfumes) as primary etiology
- Allergen injection or sublingual treatment in the preceding 2 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 |
|---|---|---|
| Temperature controlled Laminar Airflow (TLA)Also: Protexo, TLANocturnal environmental control with Temperature controlled Laminar Airflow (TLA). | Device | Temeperature controlled Laminar Airflow |
| Placebo TLAPlacebo TLA (without filtration and TLA function) | Device | Placebo TLA |
Primary outcome
miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score.
Time frame: Week -2, 0, 4, 12, 24, 36 and 52
6 secondary outcomes
FENO (Nitric Oxide in Exhaled Air)
Time frame: Week -2, 0, 4, 12, 24, 36 and 52
Lung function assessed by forced expiratory volume (FEV1), PEF (Expiratory peak flow) and FEF50 (Predicted Forced Expiratory Flow Rate at 50 Percent of Vital Capacity)
Time frame: Week -2, 0, 4, 12, 24, 36 and 52
Rhinitis symptoms assessed by questionnaire
Time frame: Week 0 and 52
RAST value and eosinophil count.
Time frame: Week 0 and 52
Asthma Control Test (ACT).
Time frame: Week -2, 0, 12, 24, 36 and 52
Resource consumption
Time frame: Week 0, 4, 12, 24, 36 and 52
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 9 Nov 2010.
- Derived from this study: PubMed 22131290Boyle RJ, Pedroletti C, Wickman M, Bjermer L, Valovirta E, Dahl R, Von Berg A, Zetterstrom O, Warner JO; 4A Study Group. Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial. Thorax. 2012 Mar;67(3):215-21. doi: 10.1136/thoraxjnl-2011-200665. Epub 2011 Nov 30.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Olof Zetterström, MD, PhD. principal investigator
University Hospital, Linkoeping
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Asthma, run by Airsonett AB at 19 sites in 6 countries.
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 9 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 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Sweden, Germany, Denmark, Norway, Finland and 1 more country. 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.
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?
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?
miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score. (time frame: Week -2, 0, 4, 12, 24, 36 and 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00986323, which also lists 1 linked publication.
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 9 Nov 2010.