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

Asthma Clinical Trial

— 4A  

Official title:

Airsonett Airshower in Allergic Asthma a Double-blind Randomized Multi-centre Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986323
• Other study ID #: Air 3-03
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2009
• Last updated: November 8, 2010
• Start date: April 2008
• Est. completion date: February 2010

Study information

• Verified date: November 2010
• Source: Airsonett AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review BoardNorway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research EthicsDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeFinland: Ethics CommitteeFinland: Finnish Medicines AgencyGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Other known NCT identifiers

• NCT00986388
• NCT00986622
• NCT00986726
• NCT00986934

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 70 Years

Eligibility

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

Other protocol-defined exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Temperature controlled Laminar Airflow (TLA)
Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA).
• Placebo TLA
Placebo TLA (without filtration and TLA function)

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Bispebjerg Hospital	Copenhagen
Finland	Turku Allergy Centre	Turku
Germany	Ruhr University of Bochum	Bochum
Germany	University of München	München
Germany	University of Rostock	Rostock
Germany	Marien Hospital Wesel	Wesel
Norway	Ullevaal University Hospital	Oslo
Norway	St. Olavs Hospital	Trondheim
Sweden	Ängelholm Hospital	Angelholm
Sweden	Sahlgrenska University Hospital, Sweden	Gothenburg
Sweden	Jonkoping County Hospital	Jonkoping
Sweden	County Council of Värmland	Karlstad
Sweden	University Hospital, Linkoeping	Linkoeping
Sweden	Lund University Hospital	Lund
Sweden	Karolinska University Hospital	Stockholm
Sweden	S:t Görans Hospital, Sweden	Stockholm
Sweden	Stockholm South General Hospital	Stockholm
United Kingdom	Imperial College London	London

Sponsors (3)

Lead Sponsor	Collaborator
Airsonett AB	Commitum AB, Croel AB

Countries where clinical trial is conducted

Denmark,  Finland,  Germany,  Norway,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score.		Week -2, 0, 4, 12, 24, 36 and 52	No
Secondary	FENO (Nitric Oxide in Exhaled Air)		Week -2, 0, 4, 12, 24, 36 and 52	No
Secondary	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	No
Secondary	Rhinitis symptoms assessed by questionnaire		Week 0 and 52	No
Secondary	RAST value and eosinophil count.		Week 0 and 52	No
Secondary	Asthma Control Test (ACT).		Week -2, 0, 12, 24, 36 and 52	No
Secondary	Resource consumption		Week 0, 4, 12, 24, 36 and 52	No