Efficacy Study of Temperature Controlled Laminar Airflow (TLA)-Treatment in Perennial Allergic Asthma

NCT ID: NCT00986323

Last Updated: 2010-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-02-28

Brief 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.

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

Keywords

Asthma; Temperature controlled Laminar Airflow; TLA; Perennial allergy; Quality of life; Environmental control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Temeperature controlled Laminar Airflow

Active treatment with Temperature controlled Laminar Airflow (TLA)

Group Type: ACTIVE_COMPARATOR

Temperature controlled Laminar Airflow (TLA)

Intervention Type: DEVICE

Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA).

Placebo TLA

Placebo TLA treatment

Group Type: PLACEBO_COMPARATOR

Placebo TLA

Intervention Type: DEVICE

Placebo TLA (without filtration and TLA function)

Interventions

Temperature controlled Laminar Airflow (TLA)

Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA).

Intervention Type: DEVICE

Placebo TLA

Placebo TLA (without filtration and TLA function)

Intervention Type: DEVICE

Other Intervention Names

Protexo; TLA

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Significant cardiovascular disease
• Participation in the present trial of a family member within the same household

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Commitum AB

INDUSTRY

Sponsor Role: collaborator

Croel AB

INDUSTRY

Sponsor Role: collaborator

Airsonett AB

INDUSTRY

Sponsor Role: lead

Responsible Party

University Hospital, Linkoeping, Sweden

Principal Investigators

Olof Zetterström, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Linkoeping

Locations

Aarhus University Hospital

Aarhus, , Denmark

Bispebjerg Hospital

Copenhagen, , Denmark

Turku Allergy Centre

Turku, , Finland

Ruhr University of Bochum

Bochum, , Germany

University of München

München, , Germany

University of Rostock

Rostock, , Germany

Marien Hospital Wesel

Wesel, , Germany

Ullevaal University Hospital

Oslo, , Norway

St. Olavs Hospital

Trondheim, , Norway

Ängelholm Hospital

Ängelholm, , Sweden

Sahlgrenska University Hospital, Sweden

Gothenburg, , Sweden

Jonkoping County Hospital

Jönköping, , Sweden

County Council of Värmland

Karlstad, , Sweden

University Hospital, Linkoeping

Linköping, , Sweden

Lund University Hospital

Lund, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

S:t Görans Hospital, Sweden

Stockholm, , Sweden

Stockholm South General Hospital

Stockholm, , Sweden

Imperial College London

London, , United Kingdom

Countries

Denmark; Finland; Germany; Norway; Sweden; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 22131290 (View on PubMed)

Other Identifiers

Air 3-03

Identifier Type: -

Identifier Source: org_study_id

NCT00986388

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Identifier Source: nct_alias

NCT00986622

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Identifier Source: nct_alias

NCT00986726

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Identifier Source: nct_alias

NCT00986934

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Identifier Source: nct_alias