Respiratory Tract InfectionsRESPIRENCT01047696
Randomised Exposure Study of Pollution Indoors and Respiratory Effects
A study testing Plancha in people with Respiratory Tract Infections and Pneumonia, run by University of California, Berkeley at 1 site in Guatemala.
Trial summary
The purpose of this study was to determine whether reduced exposure to indoor air pollution would reduce ALRI incidence in children <18 months of age. Households were randomized to receive a chimney stove (intervention group) or continue using an open fire for cooking and heating (control group). Read more about this study
- Who is it for?
- Ages Up to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Pneumonia
- What is being tested?
- Plancha
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 537 participants
- Where
- 1 siteGuatemala
- Study dates
- Oct 2002to Mar 2005
- Phase
- Interventional
- 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 Up to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Households were invited to participate in the study if they met the following inclusion criteria:
- Used only an open fire for cooking and heating
- Had a pregnant woman or child < 4 months residing in the home
- Identified as Mam (the regional ethnic group), and had
- Minimal summer migration (less than 12 weeks per year)
Who cannot join
- Households were excluded from participating if:
- The household was already using a chimney stove for cooking
- There was no child <4 months of age or a pregnant woman residing in the home
- Seasonal migration required the family to move to another region for more than 12 weeks of the year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Particulate Air Pollution Exposure and Childhood Acute Respiratory Infections in Guatemala: A Randomized Intervention
The purpose of this study was to determine whether reduced exposure to indoor air pollution would reduce ALRI incidence in children <18 months of age. Households were randomized to receive a chimney stove (intervention group) or continue using an open fire for cooking and heating (control group).
Read the detailed description
Acute lower respiratory infections (ALRI) are the chief killer of children. Most cases are pneumonia and the majority occur among poor children under five years in developing countries. Poverty might be said to be the primary cause, which manifests as malnutrition, including micro-nutrient deficiencies, and lack of access to medical care. Another attribute of poverty is household indoor air pollution (HAP) from use of unprocessed solid fuels such as biomass (wood, animal dung and crop wastes) and coal in simple stoves. A meta-analysis of published observational studies found that young children exposed to smoke from household solid fuel use had a rate of ALRI twice that of children not exposed or where clean fuels were used. Recent studies have shown similar ALRI risks associated with short-term air pollution measurements and other indicators of exposure.
- Conditions
- Respiratory Tract Infections, Pneumonia
- Being tested
- Plancha
- Medical subject headings
- Respiratory Tract Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlanchaDevice
locally developed chimney stove
| Study group | Role | What they receive |
|---|---|---|
| Open fire | No intervention | Households continuing to use an open fire for cooking and heating |
| Chimney stove | Experimental | Households randomized to receive a chimney stove (plancha) for cooking and heating Receives: Device: Plancha |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure was physician-diagnosed pneumonia in children
Measured: Through 18 months of age
Secondary outcomes (1)
Severe (hypoxaemic) and RSV pneumonia
Measured: Through 18 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startOct 2002
- Primary completionDec 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Universidad del Valle, Guatemala, University of Liverpool
- Investigators
- Kirk R Smith, PhD, MPH, Principal investigator, UC Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047696
- Sponsor's protocol ID
- 2003-8-165
- Other IDs
- R01ES010178
- Acronym
- RESPIRE
- Status last verified
- Aug 2009
- First submitted
- 12 Jan 2010
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Smith-Sivertsen T, Diaz E, Pope D, Lie RT, Diaz A, McCracken J, Bakke P, Arana B, Smith KR, Bruce N. Effect of reducing indoor air pollution on women's respiratory symptoms and lung function: the RESPIRE Randomized Trial, Guatemala. Am J Epidemiol. 2009 Jul 15;170(2):211-20. doi: 10.1093/aje/kwp100. Epub 2009 May 14.
PubMed 19443665Diaz E, Bruce N, Pope D, Diaz A, Smith KR, Smith-Sivertsen T. Self-rated health among Mayan women participating in a randomised intervention trial reducing indoor air pollution in Guatemala. BMC Int Health Hum Rights. 2008 Jun 5;8:7. doi: 10.1186/1472-698X-8-7.
PubMed 18533994Diaz E, Bruce N, Pope D, Lie RT, Diaz A, Arana B, Smith KR, Smith-Sivertsen T. Lung function and symptoms among indigenous Mayan women exposed to high levels of indoor air pollution. Int J Tuberc Lung Dis. 2007 Dec;11(12):1372-9.
PubMed 18034961McCracken JP, Smith KR, Diaz A, Mittleman MA, Schwartz J. Chimney stove intervention to reduce long-term wood smoke exposure lowers blood pressure among Guatemalan women. Environ Health Perspect. 2007 Jul;115(7):996-1001. doi: 10.1289/ehp.9888.
PubMed 17637912Diaz E, Smith-Sivertsen T, Pope D, Lie RT, Diaz A, McCracken J, Arana B, Smith KR, Bruce N. Eye discomfort, headache and back pain among Mayan Guatemalan women taking part in a randomised stove intervention trial. J Epidemiol Community Health. 2007 Jan;61(1):74-9. doi: 10.1136/jech.2006.043133.
PubMed 17183019Smith KR, McCracken JP, Thompson L, Edwards R, Shields KN, Canuz E, Bruce N. Personal child and mother carbon monoxide exposures and kitchen levels: methods and results from a randomized trial of woodfired chimney cookstoves in Guatemala (RESPIRE). J Expo Sci Environ Epidemiol. 2010 Jul;20(5):406-16. doi: 10.1038/jes.2009.30. Epub 2009 Jun 17.
PubMed 19536077McCracken JP, Schwartz J, Bruce N, Mittleman M, Ryan LM, Smith KR. Combining individual- and group-level exposure information: child carbon monoxide in the Guatemala woodstove randomized control trial. Epidemiology. 2009 Jan;20(1):127-36. doi: 10.1097/EDE.0b013e31818ef327.
PubMed 19057384Bruce N, Weber M, Arana B, Diaz A, Jenny A, Thompson L, McCracken J, Dherani M, Juarez D, Ordonez S, Klein R, Smith KR. Pneumonia case-finding in the RESPIRE Guatemala indoor air pollution trial: standardizing methods for resource-poor settings. Bull World Health Organ. 2007 Jul;85(7):535-44. doi: 10.2471/blt.06.035832.
PubMed 17768502
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Particulate Air Pollution Exposure and Childhood Acute Respiratory Infections in Guatemala: A Randomized Intervention
- ClinicalTrials.gov ID
- NCT01047696
- Acronym / sponsor ID
- RESPIRE / 2003-8-165
- Conditions
- Respiratory Tract Infections, Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- World Health Organization, Universidad del Valle, Guatemala, University of Liverpool
- Study start
- Oct 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 13 Jan 2010 (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 purpose of this study was to determine whether reduced exposure to indoor air pollution would reduce ALRI incidence in children <18 months of age. Households were randomized to receive a chimney stove (intervention group) or continue using an open fire for cooking and heating (control group).
Detailed description
Acute lower respiratory infections (ALRI) are the chief killer of children. Most cases are pneumonia and the majority occur among poor children under five years in developing countries. Poverty might be said to be the primary cause, which manifests as malnutrition, including micro-nutrient deficiencies, and lack of access to medical care. Another attribute of poverty is household indoor air pollution (HAP) from use of unprocessed solid fuels such as biomass (wood, animal dung and crop wastes) and coal in simple stoves. A meta-analysis of published observational studies found that young children exposed to smoke from household solid fuel use had a rate of ALRI twice that of children not exposed or where clean fuels were used. Recent studies have shown similar ALRI risks associated with short-term air pollution measurements and other indicators of exposure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open fire | No intervention | –Households continuing to use an open fire for cooking and heating |
| Chimney stove | Experimental | Device: PlanchaHouseholds randomized to receive a chimney stove (plancha) for cooking and heating |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Households were invited to participate in the study if they met the following inclusion criteria:
- Used only an open fire for cooking and heating
- Had a pregnant woman or child < 4 months residing in the home
- Identified as Mam (the regional ethnic group), and had
- Minimal summer migration (less than 12 weeks per year)
Key exclusion criteria (4 listed)
- The household was already using a chimney stove for cooking
- There was no child <4 months of age or a pregnant woman residing in the home
- Seasonal migration required the family to move to another region for more than 12 weeks of the year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Planchalocally developed chimney stove | Device | Chimney stove |
Primary outcome
The primary outcome measure was physician-diagnosed pneumonia in children
Time frame: Through 18 months of age
1 secondary outcome
Severe (hypoxaemic) and RSV pneumonia
Time frame: Through 18 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Background: PubMed 19443665Smith-Sivertsen T, Diaz E, Pope D, Lie RT, Diaz A, McCracken J, Bakke P, Arana B, Smith KR, Bruce N. Effect of reducing indoor air pollution on women's respiratory symptoms and lung function: the RESPIRE Randomized Trial, Guatemala. Am J Epidemiol. 2009 Jul 15;170(2):211-20. doi: 10.1093/aje/kwp100. Epub 2009 May 14.
- Background: PubMed 18533994Diaz E, Bruce N, Pope D, Diaz A, Smith KR, Smith-Sivertsen T. Self-rated health among Mayan women participating in a randomised intervention trial reducing indoor air pollution in Guatemala. BMC Int Health Hum Rights. 2008 Jun 5;8:7. doi: 10.1186/1472-698X-8-7.
- Background: PubMed 18034961Diaz E, Bruce N, Pope D, Lie RT, Diaz A, Arana B, Smith KR, Smith-Sivertsen T. Lung function and symptoms among indigenous Mayan women exposed to high levels of indoor air pollution. Int J Tuberc Lung Dis. 2007 Dec;11(12):1372-9.
- Background: PubMed 17637912McCracken JP, Smith KR, Diaz A, Mittleman MA, Schwartz J. Chimney stove intervention to reduce long-term wood smoke exposure lowers blood pressure among Guatemalan women. Environ Health Perspect. 2007 Jul;115(7):996-1001. doi: 10.1289/ehp.9888.
- Background: PubMed 17183019Diaz E, Smith-Sivertsen T, Pope D, Lie RT, Diaz A, McCracken J, Arana B, Smith KR, Bruce N. Eye discomfort, headache and back pain among Mayan Guatemalan women taking part in a randomised stove intervention trial. J Epidemiol Community Health. 2007 Jan;61(1):74-9. doi: 10.1136/jech.2006.043133.
- Results publication: PubMed 19536077Smith KR, McCracken JP, Thompson L, Edwards R, Shields KN, Canuz E, Bruce N. Personal child and mother carbon monoxide exposures and kitchen levels: methods and results from a randomized trial of woodfired chimney cookstoves in Guatemala (RESPIRE). J Expo Sci Environ Epidemiol. 2010 Jul;20(5):406-16. doi: 10.1038/jes.2009.30. Epub 2009 Jun 17.
- Results publication: PubMed 19057384McCracken JP, Schwartz J, Bruce N, Mittleman M, Ryan LM, Smith KR. Combining individual- and group-level exposure information: child carbon monoxide in the Guatemala woodstove randomized control trial. Epidemiology. 2009 Jan;20(1):127-36. doi: 10.1097/EDE.0b013e31818ef327.
- Results publication: PubMed 17768502Bruce N, Weber M, Arana B, Diaz A, Jenny A, Thompson L, McCracken J, Dherani M, Juarez D, Ordonez S, Klein R, Smith KR. Pneumonia case-finding in the RESPIRE Guatemala indoor air pollution trial: standardizing methods for resource-poor settings. Bull World Health Organ. 2007 Jul;85(7):535-44. doi: 10.2471/blt.06.035832.
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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.
Kirk R Smith, PhD, MPH principal investigator
UC Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plancha in people with Respiratory Tract Infections and Pneumonia, run by University of California, Berkeley at 1 site in Guatemala.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 13 Jan 2010. 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 Guatemala. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure was physician-diagnosed pneumonia in children (time frame: Through 18 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047696, which also lists 8 linked publications.
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 13 Jan 2010.