Pulmonary DiseaseNCT01329159
Cardio-Respiratory Health and Indoor Pollution
An observational study of Pulmonary Disease and Cardiovascular Disease, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
The aim of this study is to assess in the sample of population resident in the KHUMBU valley (NEPAL): 1. the respiratory function decline by means of spirometry and the respiratory health by means of questionnaire and six-minute walking distance 2. Read more about this study
- Who is it for?
- Ages 14 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Cardiovascular Disease
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: residents in the Kumbu Valley (Nepal)
Who may be able to join
- residents in the villages of the valley
Who cannot join
- under the age of 14
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Clinical and Experimental Medicine- section of Respiratory Disease-University of Ferrara
Ferrara, Ferrara, 44100
Annalisa Cogo, MD, +390532210420, cga@unife.it
Annalisa Cogo, MD
About this study
Official title: Cardio-Respiratory Health in High Altitude Residents Exposed to Indoor Pollution
The aim of this study is to assess in the sample of population resident in the KHUMBU valley (NEPAL):
- the respiratory function decline by means of spirometry and the respiratory health by means of questionnaire and six-minute walking distance
- the presence of markers of early atherosclerosis with ultrasound and to estimate the value of systolic pulmonary pressure in comparison with not exposed subjects.
Read more
The investigators hypothesize that the chronic exposure to indoor pollution
- can accelerate the physiological respiratory function decline, usually around 15-20mL/year in healthy subjects
- induce cardiovascular impairment The population of high altitude villages is a unique sample to study the effect of the only indoor pollution. In fact, the absence of traffic, due to the lack of roads, and the very low level of smoking habits allow to have no other confounding factors
- to study and analyze how the architectural features of the buildings of the village (distribution of domestic locals, natural or non natural ventilation systems, domestic activities, materials used, etc.) affect the indoor pollution from carbon monoxide, which necessarily is developed indoor during the daily life activities.
What the project prospects is to gather information focused on the scale of the building, independently from the typology, to study a model that will help to describe which aspects are most important to what concern the genesis of the pollution of the indoor air.
- Conditions
- Pulmonary Disease, Cardiovascular Disease
- Keywords
- High altitude, respiratory function, cardiorespiratory health, indoor pollution
- Medical subject headings
- Lung Diseases, Cardiovascular Diseases, Altitude Sickness, Respiratory Aspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Investigators
- Annalisa Cogo, MD, Study director, University of Ferrara, ItalyLorenza Pratali, MD, Principal investigator, Institute of Clinical Physiology National Council of Research, Pisa, ItalyLuca Pomidori, PhD, Principal investigator, Università degli Studi di FerraraSanjay Nath Khanal, MD, Principal investigator, Kathmandu UniversityEnrico Duo, Principal investigator, Università degli Studi di FerraraMaria Rosa Bruno, MD, Principal investigator, Institute of Clinical Physiology National Council of Research, Pisa, ItalyChan Bahadur Thapa, MD, Principal investigator, Tribhuvan University Institute of Medicine (Nepal)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329159
- Sponsor's protocol ID
- HA indoor/pollution
- Status last verified
- Mar 2011
- First submitted
- 1 Apr 2011
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-Respiratory Health in High Altitude Residents Exposed to Indoor Pollution
- ClinicalTrials.gov ID
- NCT01329159
- Acronym / sponsor ID
- HA indoor/pollution
- Conditions
- Pulmonary Disease, Cardiovascular Disease
- Keywords
- High altitude, respiratory function, cardiorespiratory health, indoor pollution
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess in the sample of population resident in the KHUMBU valley (NEPAL):
- the respiratory function decline by means of spirometry and the respiratory health by means of questionnaire and six-minute walking distance
- the presence of markers of early atherosclerosis with ultrasound and to estimate the value of systolic pulmonary pressure in comparison with not exposed subjects.
The investigators hypothesize that the chronic exposure to indoor pollution
- can accelerate the physiological respiratory function decline, usually around 15-20mL/year in healthy subjects
- induce cardiovascular impairment The population of high altitude villages is a unique sample to study the effect of the only indoor pollution. In fact, the absence of traffic, due to the lack of roads, and the very low level of smoking habits allow to have no other confounding factors
- to study and analyze how the architectural features of the buildings of the village (distribution of domestic locals, natural or non natural ventilation systems, domestic activities, materials used, etc.) affect the indoor pollution from carbon monoxide, which necessarily is developed indoor during the daily life activities.
What the project prospects is to gather information focused on the scale of the building, independently from the typology, to study a model that will help to describe which aspects are most important to what concern the genesis of the pollution of the indoor air.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- residents in the Kumbu Valley (Nepal)
Key inclusion criteria (1 listed)
- residents in the villages of the valley
Key exclusion criteria (1 listed)
- under the age of 14
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annalisa Cogo, MD study director
University of Ferrara, Italy
Lorenza Pratali, MD principal investigator
Institute of Clinical Physiology National Council of Research, Pisa, Italy
Luca Pomidori, PhD principal investigator
Università degli Studi di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease and Cardiovascular Disease, run by Università degli Studi di Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Cogo, MD (+390532210420, cga@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2011.