NCT01329159

Brief Summary

The aim of this study is to assess in the sample of population resident in the KHUMBU valley (NEPAL):

  1. 1.the respiratory function decline by means of spirometry and the respiratory health by means of questionnaire and six-minute walking distance
  2. 2.the presence of markers of early atherosclerosis with ultrasound and to estimate the value of systolic pulmonary pressure in comparison with not exposed subjects.
  3. 3.can accelerate the physiological respiratory function decline, usually around 15-20mL/year in healthy subjects
  4. 4.induce cardiovascular impairment
  5. 5.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 5, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

April 1, 2011

Last Update Submit

April 4, 2011

Conditions

Keywords

High altituderespiratory functioncardiorespiratory healthindoor pollution

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

residents in the Kumbu Valley (Nepal)

You may qualify if:

  • residents in the villages of the valley

You may not qualify if:

  • under the age of 14

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical and Experimental Medicine- section of Respiratory Disease-University of Ferrara

Ferrara, Ferrara, 44100, Italy

Location

MeSH Terms

Conditions

Lung DiseasesCardiovascular DiseasesAltitude SicknessRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Annalisa Cogo, MD

    University of Ferrara, Italy

    STUDY DIRECTOR
  • Lorenza Pratali, MD

    Institute of Clinical Physiology National Council of Research, Pisa, Italy

    PRINCIPAL INVESTIGATOR
  • Luca Pomidori, PhD

    Università degli Studi di Ferrara

    PRINCIPAL INVESTIGATOR
  • Sanjay Nath Khanal, MD

    Kathmandu University

    PRINCIPAL INVESTIGATOR
  • Enrico Duo

    Università degli Studi di Ferrara

    PRINCIPAL INVESTIGATOR
  • Maria Rosa Bruno, MD

    Institute of Clinical Physiology National Council of Research, Pisa, Italy

    PRINCIPAL INVESTIGATOR
  • Chan Bahadur Thapa, MD

    Tribhuvan University Institute of Medicine (Nepal)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Cogo, MD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 5, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

July 1, 2012

Last Updated

April 5, 2011

Record last verified: 2011-03

Locations