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HIPWOODS - Health Effects Related to Exposure to Particle Pollution From Woodburning Stoves (HIPWOODS)

1 febbraio 2012 aggiornato da: University of Aarhus

Health Effects Related to Exposure to Particle Pollution From Woodburning

The study intends to focus on health effects and symptoms related to particle exposure from wood burning stoves

The objective is to determine whether moderate exposure to particles from wood smoke in a real life situation causes an systemic inflammatory response in peripheral blood or in lower airways. 24 healthy subjects (normal healthy subjects and mild asthmatics to study the asthmatic response) is selected for the study. A randomized double blind crossover procedure will be followed with a PM exposure concentration of 200ug/m3, 400ug/m3 or clean air as the control exposure. Exposure will take place in a climate chamber using wood burning in an appropriate wood stove.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

Public health is concerned with the physical, mental and environmental health of communities and populations at risk for disease and injury. Generally, the determination of health effects associated with indoor and outdoor exposures is difficult since documented cause-and-effect relationships are rare and the exposure and dosage data is sparse. Information about actual human exposure to different types of pollution has several important uses, including informing risk assessments, helping predict the potential consequences of exposures, and developing exposure criteria for regulations and other public policy guidance.

Wood-burning stoves have been a popular heating source for decades. Unfortunately, wood-burning stoves can emit substantial quantities of pollutants to outdoor and indoor air. Among the pollutants are: chlorinated dioxin, carbon monoxide, methane, volatile organic compounds (VOC), nitrogen oxides, polycyclic aromatic hydrocarbons (PAH), and fine particulate matter (PM10, PM2.5, fine and ultra fine particles). Recent studies indicate that the use of wood-burning stoves for heating of dwellings is one of the important outdoor particle sources [Glasius et al. 2004] in residential district in Denmark. This has resulted in an increase in public exposure to indoor and outdoor wood smoke related pollutants, which has prompted widespread concern about the adverse human health consequences that may be associated with wood smoke exposure.

Air pollution is a major aggravation of respiratory symptoms and disease. Effects are decreases in pulmonary function and evidence of inflammation as well as suggestions of increases in chronic respiratory disease. Orozco-Levi et al. (2006) showed strong association between wood smoke exposure and obstructive pulmonary disease. Several studies have shown that especially the small particles, has an effect on airways, and that asthmatic subjects may be the group at greatest risk from air pollutants. The awareness of the impact of airborne particles, particularly fine and ultra fine particles, on health is growing. In recent years, exposure to fine and ultra fine airborne particles has been identified as an important factor affecting human health [Seaton et al., 1995; Schwartz et al., 1996; Oberdörster et al., 1994; Alvin et al., 2000]. Several researchers hypothesize that an increased mortality is associated with the particle levels prevailing in urban air [Jamriska et al., 1999; Dockery et al., 1993]. Mølhave et al (2000; 2005) have suggested that reactive short-lived compounds resulting from reactions between ozone and particulate matter cause indoor air quality complaints and objective health effects such as impaired lung functions.

Particulate air pollution is also known to increase cardiovascular morbidity and mortality. Still the existing scientific knowledge and foundation for evaluating the underlying mechanisms and influence of particle exposure on human immune system are limited. Wood smoke particles, at levels that can be found in smoky indoor environments, seem to affect inflammation. Barregard et al observed a significant increase in S-Amyloid and Faktor VIII/vWf after 0, 3 and 20 hours of exposure to wood smoke. After 20 hours also and increase in Faktor VIII was registred. Surpise-lingly, an IL.-6 decrease was observed after 3 hours. [Barregard et al, 2006]. The particles may also act by increasing blood coagulation factors [Seaton et al 1995]. Both effects may be involved in the mechanisms whereby particulate air pollution affects cardiovascular morbidity and mortality.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Aarhus C, Danimarca, 8000
        • Institute of Environmental and Occupational Medicine , Institute of Public Health , The Faculty of Health Sciences

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 64 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Twenty-four, non-smoking atopic volunteers with normal lung function and bronchial reactivity are recruited for the study. Atopy is determined by skin-prick testing to common aeroallergens.

Exclusion Criteria:

  • Smokers, pregnant women and other subjects with current or previous diseases, which could involve a risk for the subject or possibly influence the outcome measurements, will be excluded from the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore fittizio: 1
Clean air
Subjects are exposed at rest to the exposures for 3 h in our climate chamber
Sperimentale: 2
Wood smoke particle concentration of 200 ug/m3
Subjects are exposed at rest to the exposures for 3 h in our climate chamber
Sperimentale: 3
Wood smoke particle concentration of 400 ug/m3
Subjects are exposed at rest to the exposures for 3 h in our climate chamber

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Different Inflammation Biomarkers
Lasso di tempo: Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post.
Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post.

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Baseline and follow up measurements are: spirometry, exhaled breath condensate, nasal lavage, nasal patency, blood sampling and symptoms.
Lasso di tempo: Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post.
Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Torben Sigsgaard, Professor, Department of Environmental and Occupational Medicine , Institute of Public Health , The Faculty of Health Sciences

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2007

Completamento primario (Effettivo)

1 giugno 2008

Completamento dello studio (Effettivo)

1 novembre 2009

Date di iscrizione allo studio

Primo inviato

5 maggio 2008

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2008

Primo Inserito (Stima)

7 maggio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

2 febbraio 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 febbraio 2012

Ultimo verificato

1 febbraio 2012

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2104-05-0003
  • Projekt nr: 0502-

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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