AsthmaPhase 2NCT00987064
Clinical Effects of Temperature Controlled Laminar Airflow (TLA)
A Phase 2 study of Asthma and Perennial Allergy, run by Airsonett AB at 2 sites in Sweden.
Trial summary
The purpose of this study is to determine whether clean air administered to the breathing zone with Temperature controlled Laminar Airflow (TLA) during night is effective in the treatment of perennial allergic asthma. Read more about this study
- Who is it for?
- Ages 12 to 28 years
- Conditions the study is for
- Asthma, Perennial Allergy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesSweden
- Study dates
- Oct 2005to Jun 2006
- Phase
- Phase 2
- 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 12 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed for asthma for more than 1 year.
- More than 12% reactivity in FEV1 on bronchodilating medication or less than 90% of the FEV1 reference value according to Hedenström.
- Perennial allergy
- At least 3-mm wheal reaction in a skin prick test to at least one of following: House dust, Mold spores, dust mites, animal hair and dander.
- Little or no reactivity to other inhalant allergens.
- No known allergy to another inhalant allergen or chemical to which there is exposure in winter time.
Show all 13Show fewer
- No allergen injection treatment in the preceding 2 years.
- A history of a requirement for daily medication for asthma including;
- 400µg steroid medication (Pulmicort or equal) for children and 800µg for adults.
- Beta agonist treatment on less than 4 days per week.
- Willingness to follow the clinical trial protocol, including medications, baseline and follow-up visits and procedures.
- Smoking in the family
- Participation in a drug trial
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
University Hospital, Linkoeping
Linköping, SE-581 91
Karolinska University Hospital
Stockholm, SE-171 76
About this study
Official title: Clinical Effects of Purified Air Administered to the Breathing Zone in Allergic Asthma
The purpose of this study is to determine whether clean air administered to the breathing zone with Temperature controlled Laminar Airflow (TLA) during night is effective in the treatment of perennial allergic asthma.
Read the detailed description
Background: Exposure to inhaled allergens is a pathogenetic factor in allergic asthma. However, most studies that previously looked at air cleaning devices have shown little or no effect on patients with perennial allergic asthma. Aims and objectives: This study aims to investigate a novel treatment, TLA, using temperature controlled laminar airflow with a very low particle concentration directed to the breathing zone of teenagers and adults with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have an effect on bronchial inflammation and quality of life. Method: Patients are randomized to start with active or placebo treatment for 10 weeks. All patients receive both active and placebo treatment with unfiltered air, with a 2-week wash-out period in between treatments. Maintenance treatment with inhaled corticosteroids is unaltered during the trial period. Health related quality of life (miniAQLQ)is the primary effectiveness measure. Exhaled nitric oxide (FeNO) and spirometry are also investigated.
- Conditions
- Asthma, Perennial Allergy
- Being tested
- Temperature controlled Laminar Airflow (Protexo), Placebo TLA
- Keywords
- Protexo, Asthma, Temperature controlled Laminar Airflow, Perennial allergy, Quality of life, MiniAQLQ, FeNO, FEV1, PEF
- 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 (Protexo)Device
Also called Protexo
The intervention is designed to reduce the allergen load in the patients breathing zone by vertically displacing the allergens, originating from the bed and the ambient room environment, with a temperature controlled laminar airflow (TLA) during night sleep. The airflow is filtered through a high efficiency particulate air filter(HEPA), slightly cooled and ''showered'' over the subject. Due to the higher density, the cooled air descends slowly, and displaces the allergens from the breathing zone.
Placebo TLADevice
TLA treatment with disabled filtration function
| Study group | Role | What they receive |
|---|---|---|
| Temperature controlled Laminar Airflow | Active comparator | Active treatment with Temperature controlled Laminar Airflow (TLA) Receives: Device: Temperature controlled Laminar Airflow (Protexo) |
| Placebo TLA | Placebo comparator | Placebo treatment with TLA (no filtration function) Receives: Device: Placebo TLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessed by mini Asthma Quality of Life Questionnaire (miniAQLQ)
Measured: Every 2 weeks of the study period
Secondary outcomes (2)
Airway inflammation measurement assessed by Exhaled nitric oxide (FeNO)
Measured: Every 5 week of the study period
Lung function (FeV1, PEF)
Measured: Every 5 week of the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startOct 2005
- Primary completionMay 2006
- Study completionJun 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Airsonett AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital, University Hospital, Linkoeping, Quintiles, Inc.
- Investigators
- Christophe Pedroletti, MD, PhD., Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987064
- Sponsor's protocol ID
- Air 3-01
- Status last verified
- Sep 2009
- First submitted
- 28 Sep 2009
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pedroletti C, Millinger E, Dahlen B, Soderman P, Zetterstrom O. Clinical effects of purified air administered to the breathing zone in allergic asthma: A double-blind randomized cross-over trial. Respir Med. 2009 Sep;103(9):1313-9. doi: 10.1016/j.rmed.2009.03.020. Epub 2009 May 13.
PubMed 19443189
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Purified Air Administered to the Breathing Zone in Allergic Asthma
- ClinicalTrials.gov ID
- NCT00987064
- Acronym / sponsor ID
- Air 3-01
- Conditions
- Asthma, Perennial Allergy
- Keywords
- Protexo, Asthma, Temperature controlled Laminar Airflow, Perennial allergy, Quality of life, MiniAQLQ, FeNO, FEV1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Airsonett ABIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital, University Hospital, Linkoeping, Quintiles, Inc.
- Study start
- Oct 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 30 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 clean air administered to the breathing zone with Temperature controlled Laminar Airflow (TLA) during night is effective in the treatment of perennial allergic asthma.
Detailed description
Background: Exposure to inhaled allergens is a pathogenetic factor in allergic asthma. However, most studies that previously looked at air cleaning devices have shown little or no effect on patients with perennial allergic asthma. Aims and objectives: This study aims to investigate a novel treatment, TLA, using temperature controlled laminar airflow with a very low particle concentration directed to the breathing zone of teenagers and adults with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have an effect on bronchial inflammation and quality of life. Method: Patients are randomized to start with active or placebo treatment for 10 weeks. All patients receive both active and placebo treatment with unfiltered air, with a 2-week wash-out period in between treatments. Maintenance treatment with inhaled corticosteroids is unaltered during the trial period. Health related quality of life (miniAQLQ)is the primary effectiveness measure. Exhaled nitric oxide (FeNO) and spirometry are also investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temperature controlled Laminar Airflow | Active comparator | Device: Temperature controlled Laminar Airflow (Protexo)Active treatment with Temperature controlled Laminar Airflow (TLA) |
| Placebo TLA | Placebo comparator | Device: Placebo TLAPlacebo treatment with TLA (no filtration function) |
Who may qualify
- Ages
- 12 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Diagnosed for asthma for more than 1 year.
- More than 12% reactivity in FEV1 on bronchodilating medication or less than 90% of the FEV1 reference value according to Hedenström.
- Perennial allergy
- At least 3-mm wheal reaction in a skin prick test to at least one of following: House dust, Mold spores, dust mites, animal hair and dander.
- Little or no reactivity to other inhalant allergens.
Key exclusion criteria (0 listed)
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 (Protexo)Also: ProtexoThe intervention is designed to reduce the allergen load in the patients breathing zone by vertically displacing the allergens, originating from the bed and the ambient room environment, with a temperature controlled laminar airflow (TLA) during night sleep. The airflow is filtered through a high efficiency particulate air filter(HEPA), slightly cooled and ''showered'' over the subject. Due to the higher density, the cooled air descends slowly, and displaces the allergens from the breathing zone. | Device | Temperature controlled Laminar Airflow |
| Placebo TLATLA treatment with disabled filtration function | Device | Placebo TLA |
Primary outcome
Quality of life assessed by mini Asthma Quality of Life Questionnaire (miniAQLQ)
Time frame: Every 2 weeks of the study period
2 secondary outcomes
Airway inflammation measurement assessed by Exhaled nitric oxide (FeNO)
Time frame: Every 5 week of the study period
Lung function (FeV1, PEF)
Time frame: Every 5 week of the study period
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 14 Jan 2015.
- Background: PubMed 19443189Pedroletti C, Millinger E, Dahlen B, Soderman P, Zetterstrom O. Clinical effects of purified air administered to the breathing zone in allergic asthma: A double-blind randomized cross-over trial. Respir Med. 2009 Sep;103(9):1313-9. doi: 10.1016/j.rmed.2009.03.020. Epub 2009 May 13.
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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.
Christophe Pedroletti, MD, PhD. principal investigator
Karolinska University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Asthma and Perennial Allergy, run by Airsonett AB at 2 sites 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 13 inclusion and 0 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 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Quality of life assessed by mini Asthma Quality of Life Questionnaire (miniAQLQ) (time frame: Every 2 weeks of the study period). 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 NCT00987064, 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 14 Jan 2015.