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临床试验/NCT00220753
NCT00220753已完成不适用

Air Cleaners for Children and Adolescents With Asthma and Dog Allergy

Sykehuset Innlandet HF2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Bronchial hyperactivity by cold air hyperventilation

研究概览

简要总结

The purpose is to find out if Icleen IQAir, HEPA-filter air cleaners with high capacity and pre-set speed functions, have a beneficial effect on patients with asthma and allergy to dogs.

Air cleaners will be installed in the bedrooms and living rooms in the homes of children and adolescents aged 8-17 years at the study entry, with allergy to dogs, but not to house dust mites.

The investigators will look upon the significance of this study, and of a previous study with a similar design and the same main parameters to find out if this trial supports the results of the first trial by the same project leader, or makes it likely that the seemingly beneficial effects of the first study occurred by chance.

Main parameters:

  • hyperventilation cold air challenge test

Supportive parameters:

  • serum ECP
  • symptom scores

The trial will be a parallel, double blind placebo controlled one.

详细描述

Project leader: Leif Bjarte Rolfsjord, M.D., section leader, Paediatric Department Sykehuset Innlandet HF Elverum-Hamar; Ragnhild Halvorsen, M.D. Ph.D., Voksentoppen, Paediatric Clinic, Rikshospitalet; Leiv Sandvik, Ph.D. professor, research leader statistics, Competence Centre for Clinical Research, Ullevaal University Hospital

AIM:

To examine if powerful air cleaners with HEPA-filters and a pre-set speed function making it possible to run the air cleaners at a high, but noisy speed at acceptable times, and , if wanted, at a lower, but less noisy speed at other times, (Icleen IQAir®) , have a favourable effect on asthma in children and adolescents aged 8-17 years, who are allergic to dogs, but not to house dust mite. To look at this study separately, but also look upon the total results of this study and a previous study performed by the project leader.

BACKGROUND:

The first study is not yet published. We found signs of clinically significant effects of active air cleaners by the parameters ECP in serum and bronchial hyperreactivity by a cold air hyperventilation test, but the results gave p-values at the border of statistical significance, p=0.104 for FEV1 reduction, and significant results, p=0.018 for differences in the change of ECP. The number of patients included in the study was 49, a lower number than wanted in the first place. We did not find significant effects on Liz Juniper's Life Quality Scale scores. Yet, there are reasons to believe that the results of the first study may have clinical significance. A cold air hyperventilation test reflects a real life situation in interior parts of Norway, resembling outdoor winter conditions strongly. In the first study Allergy Control encasing over pillows, eiderdowns and mattresses were applied compared to placebo, but no signs of effects were found on these children aged 7 to 17 with allergy to dog or cat, but not to house dust mites. The reason to exclude house dust mite allergic patients in the first trial was to examine if encasings could have any effect on patients without house dust mite allergy, and the fact that house dust mite allergy is less common in Northern interior areas, where the trial took place. Other studies indicate, however, that air cleaners can reduce allergens from dogs and cats, but not most other indoor allergens (3). We want to perform a new trial, and publish the results from each trial in one publication, but also look upon the results of a meta-analysis of both studies. Our hope is that the two trials can give more reliable information about the effects of the air cleaners. This time, no dust analyses will be taken, because dust analyses from the first trial, sent to dr. Susanne Lau at the Charité-Virchow Clinic in Berlin, showed that the air cleaners removed considerable amounts of dust (personal message from dr. Lau). The results have been summarised in an article by Groth C et al. in Allergy in 2002, and a manuscript for an article is now sent to Allergy for publication. The efficiency of IQAir air cleaners has also been documented by Stiftung Warentest in Germany. Due to limited resources and the signs of low sensitivity in such a trial, Liz Juniper's Life Quality Scale will not be applied this time. For economic reasons, hair samples for nicotine analysis will not be taken this time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents between 8 and 17 years of age at the start of the trial (born after 01 March '88, but before 01 September '97).
  • Bronchial asthma, diagnosed by a physician, and confirmed by a physician at a paediatric department of a Norwegian Hospital.
  • Allergy against dogs, confirmed by skin prick test. Average infiltrate at least 4 millimetres against dog, diagnosed by a new skin prick test at entry. For details about skin prick test, see attachment no.
  • Having had nose or breathing symptoms by contact with dogs, when no drugs against asthma or allergy have been taken.
  • Able to co-operate at cold air hyperventilation test and spirometry (see attachment no. 2).
  • Given written consent (by parents of children below 12; by parents and child when above 12, but below 16; by patient when above 16).

排除标准

  • Positive house dust mite skin prick test, with a more than 3 mm infiltrate.
  • Having taken oral beta-2-agonists or theophylline preparations for the last 2 weeks before trial start, or oral steroids for the last 3 months before start of the trial.
  • Active smoking.
  • Dogs or cats in the home.
  • Staying away from the home continuously for more than 14 days in the trial period or during the last month before trial start.
  • Being an in-patient in a special department or institution for asthma and allergy in the trial period or the last 3 months before the trial.
  • Having another chronic disease that can influence the results of ECP or cold air hyperreactivity tests.
  • Other types of mechanical ventilation or air filtration systems in the homes, except for those for kitchen stoves.

结局指标

主要结局

Bronchial hyperactivity by cold air hyperventilation

时间窗: September 2005 - February 2006

次要结局

  • Serum ECP(September 2005- February 2006)
  • Asthma symptom score(September 2005 - February 2006)
  • Allergic rhinitis symptom score(September 2005 - February 2006)

研究者

申办方类型
Other

研究点 (2)

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