Effect of Temperature Controlled Laminar Airflow (TLA) on Bronchial Inflammation in Asthma

This study has been completed.
Sponsor:
Collaborators:
Commitum AB
Croel AB
Information provided by:
Airsonett AB
ClinicalTrials.gov Identifier:
NCT00986388
First received: September 28, 2009
Last updated: November 8, 2010
Last verified: November 2010
  Purpose

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 as add on treatment in patients with perennial allergic asthma.


Condition Intervention Phase
Asthma
Device: Temperature controlled Laminar Airflow (TLA) - Protexo
Device: Placebo TLA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sampling of Induced Sputum in the 4A Study

Resource links provided by NLM:


Further study details as provided by Airsonett AB:

Primary Outcome Measures:
  • Concentration of inflammatory cells and mediators in induced sputum. [ Time Frame: Week 0, 4, 12 and 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2008
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Temeperature controlled Laminar Airflow
Active treatment with Temperature controlled Laminar Airflow (TLA)
Device: Temperature controlled Laminar Airflow (TLA) - Protexo
Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA)
Other Names:
  • Protexo
  • TLA
Placebo Comparator: Placebo TLA
Placebo TLA treatment
Device: Placebo TLA
Placebo TLA (without filtration and TLA function)

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 regulated Laminar Airflow (TLA) with a very low particle concentration directed to the breathing zone of subjects with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have a positive effect on the bronchial inflammation measured by inflammatory cells and inflammatory mediators in induced sputum.

Method: This is a double blind, randomized 52 week parallel trial comparing active and placebo treatment with TLA. 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. 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.

  Eligibility

Ages Eligible for Study:   7 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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

Other protocol-defined exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986388

Locations
Denmark
Aarhus University Hospital, Norrebrogade
Aarhus, Denmark, Dk 8000
Bispebjerg Hospital, Bispebjerg Bakke 25
Copenhagen, Denmark, DK 2400
Sponsors and Collaborators
Airsonett AB
Commitum AB
Croel AB
Investigators
Principal Investigator: Vibeke Backe, PhD, MD Bispebjerg Hospital, Copenhagen, Denmark
  More Information

No publications provided

Responsible Party: Lotte Harmsen MD, Responsible investigator, Department of Respiratory Medicine L, Bispebjerg University Hospital, Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT00986388     History of Changes
Other Study ID Numbers: Air 3-03-07, Main protocol Air 3-03 (4A)
Study First Received: September 28, 2009
Last Updated: November 8, 2010
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency

Keywords provided by Airsonett AB:
Temperature regulated Laminar Airflow
TLA
Protexo
Perennial allergy
Induced Sputum
Inflammatory cells
Inflammatory Mediators
Environmental control

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 31, 2014