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

NCT00986323 | Completed Phase 3 DMC

• 1 other identifier: Air 3-03
• Study Type: interventional
• Target: 312
• Locations: 6 countries
• Sites: 19

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.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score.

  Week -2, 0, 4, 12, 24, 36 and 52

Secondary Outcomes (6)

• FENO (Nitric Oxide in Exhaled Air)

  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)

  Week -2, 0, 4, 12, 24, 36 and 52

• Rhinitis symptoms assessed by questionnaire

  Week 0 and 52

• RAST value and eosinophil count.

  Week 0 and 52

• Asthma Control Test (ACT).

  Week -2, 0, 12, 24, 36 and 52

Study Arms (2)

Temeperature controlled Laminar Airflow

ACTIVE COMPARATOR

Active treatment with Temperature controlled Laminar Airflow (TLA)

Device: Temperature controlled Laminar Airflow (TLA)

Placebo TLA

PLACEBO COMPARATOR

Placebo TLA treatment

Device: Placebo TLA

Interventions

Temperature controlled Laminar Airflow (TLA) DEVICE

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

Also known as: Protexo, TLA

Temeperature controlled Laminar Airflow

Placebo TLA DEVICE

Placebo TLA (without filtration and TLA function)

Placebo TLA

Eligibility Criteria

• Age: 7 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Airsonett AB: lead
• Commitum AB: collaborator
• Croel AB: collaborator

Study Sites (19)

Aarhus University Hospital

Aarhus, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Turku Allergy Centre

Turku, Finland

Location

Ruhr University of Bochum

Bochum, Germany

Location

University of München

München, Germany

Location

University of Rostock

Rostock, Germany

Location

Marien Hospital Wesel

Wesel, Germany

Location

Ullevaal University Hospital

Oslo, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

Ängelholm Hospital

Ängelholm, Sweden

Location

Sahlgrenska University Hospital, Sweden

Gothenburg, Sweden

Location

Jonkoping County Hospital

Jönköping, Sweden

Location

County Council of Värmland

Karlstad, Sweden

Location

University Hospital, Linkoeping

Linköping, Sweden

Location

Lund University Hospital

Lund, Sweden

Location

Karolinska University Hospital

Stockholm, SE-171 76, Sweden

Location

S:t Görans Hospital, Sweden

Stockholm, Sweden

Location

Stockholm South General Hospital

Stockholm, Sweden

Location

Imperial College London

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22131290 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Olof Zetterström, MD, PhD.

  University Hospital, Linkoeping

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 27, 2009
• First Posted: September 29, 2009
• Study Start: April 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: November 9, 2010

Record last verified: 2010-11

Locations

SE (9); GB (1); DE (4); DK (2); NO (2); FI (1)