AsthmaNCT00037726
Antibiotics in Infancy--Risk Factor for Childhood Asthma
An observational study of Asthma and Lung Diseases, run by Augusta University.
Trial summary
To examine possible relationships between antibiotic use, as determined by prescriptions filled, and asthma in children ages 6 to 7. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2001to Mar 2004
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
No eligibility criteria
About this study
To examine possible relationships between antibiotic use, as determined by prescriptions filled, and asthma in children ages 6 to 7.
Read the detailed description
BACKGROUND:
Morbidity and mortality from childhood asthma have been increasing in all developed countries over the past three decades, including in the United States. Numerous theories have been advanced to explain this asthma epidemic, but no single theory has held up to careful scrutiny. Recent international studies have suggested a relatively strong causal relationship between increased risk of childhood asthma and exposure to antibiotics during childhood, especially during the first year of life. The increased asthma risk was seen whether antibiotics were used to treat respiratory or non-respiratory infections. While these previous studies are suggestive, there are significant methodologic concerns about each study. A major concern with most of the studies is their reliance on retrospective recall of antibiotic exposure data from parents years after the exposure. The study relied on prospective data from the Childhood Asthma Study.
DESIGN NARRATIVE:
Data were used from the prospective, NIH-funded study of the relationship between early environmental exposures and the development of asthma in a birth cohort of children followed to an average 6.7 years of age. At 6.7 years, 482 (58%) of the original 833 children were clinically examined as part of this Childhood Asthma Study (CAS). In addition to clinical histories, the 6- to 7- year clinical examination included skin tests, IgE antibody tests, pulmonary function tests and methacholine challenge. At entry all of the CAS children were within the Health Alliance Plan (HAP) HMO. The study was based on combining the CAS data set with pharmacy data extracted from the HAP data archives. This allowed an examination of possible relationships between antibiotic use, as determined by prescriptions filled, and asthma at 6 to 7 years of age. While not strictly a prospective study, these methods avoided many of the potential sources of bias found in previous studies. The study was also able to evaluate any relationships between antibiotic exposure and asthma for confounding by other risk factors such as bedroom allergen levels, pet ownership, cigarette smoke exposure, and parental history of asthma or allergy.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2002 (estimated)
- Study startApr 2001
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Dennis Ownby, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037726
- Sponsor's protocol ID
- 1174
- Other IDs
- R03HL067427
- Status last verified
- Dec 2005
- First submitted
- 20 May 2002
- Last updated
- 23 Dec 2015
- Results posted
- No
Publications
Johnson CC, Ownby DR, Zoratti EM, Alford SH, Williams LK, Joseph CL. Environmental epidemiology of pediatric asthma and allergy. Epidemiol Rev. 2002;24(2):154-75. doi: 10.1093/epirev/mxf013. No abstract available.
PubMed 12762090Williams LK, Peterson EL, Ownby DR, Johnson CC. The relationship between early fever and allergic sensitization at age 6 to 7 years. J Allergy Clin Immunol. 2004 Feb;113(2):291-6. doi: 10.1016/j.jaci.2003.11.010.
PubMed 14767444Alford SH, Zoratti E, Peterson EL, Maliarik M, Ownby DR, Johnson CC. Parental history of atopic disease: disease pattern and risk of pediatric atopy in offspring. J Allergy Clin Immunol. 2004 Nov;114(5):1046-50. doi: 10.1016/j.jaci.2004.08.036.
PubMed 15536408Ownby DR, Johnson CC. Does exposure to dogs and cats in the first year of life influence the development of allergic sensitization? Curr Opin Allergy Clin Immunol. 2003 Dec;3(6):517-22. doi: 10.1097/00130832-200312000-00015.
PubMed 14612678Johnson CC, Ownby DR, Alford SH, Havstad SL, Williams LK, Zoratti EM, Peterson EL, Joseph CL. Antibiotic exposure in early infancy and risk for childhood atopy. J Allergy Clin Immunol. 2005 Jun;115(6):1218-24. doi: 10.1016/j.jaci.2005.04.020.
PubMed 15940137
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics in Infancy--Risk Factor for Childhood Asthma
- ClinicalTrials.gov ID
- NCT00037726
- Acronym / sponsor ID
- 1174
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2001
- Study completion
- Mar 2004
- First posted
- 21 May 2002 (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.
To examine possible relationships between antibiotic use, as determined by prescriptions filled, and asthma in children ages 6 to 7.
Detailed description
BACKGROUND:
Morbidity and mortality from childhood asthma have been increasing in all developed countries over the past three decades, including in the United States. Numerous theories have been advanced to explain this asthma epidemic, but no single theory has held up to careful scrutiny. Recent international studies have suggested a relatively strong causal relationship between increased risk of childhood asthma and exposure to antibiotics during childhood, especially during the first year of life. The increased asthma risk was seen whether antibiotics were used to treat respiratory or non-respiratory infections. While these previous studies are suggestive, there are significant methodologic concerns about each study. A major concern with most of the studies is their reliance on retrospective recall of antibiotic exposure data from parents years after the exposure. The study relied on prospective data from the Childhood Asthma Study.
DESIGN NARRATIVE:
Data were used from the prospective, NIH-funded study of the relationship between early environmental exposures and the development of asthma in a birth cohort of children followed to an average 6.7 years of age. At 6.7 years, 482 (58%) of the original 833 children were clinically examined as part of this Childhood Asthma Study (CAS). In addition to clinical histories, the 6- to 7- year clinical examination included skin tests, IgE antibody tests, pulmonary function tests and methacholine challenge. At entry all of the CAS children were within the Health Alliance Plan (HAP) HMO. The study was based on combining the CAS data set with pharmacy data extracted from the HAP data archives. This allowed an examination of possible relationships between antibiotic use, as determined by prescriptions filled, and asthma at 6 to 7 years of age. While not strictly a prospective study, these methods avoided many of the potential sources of bias found in previous studies. The study was also able to evaluate any relationships between antibiotic exposure and asthma for confounding by other risk factors such as bedroom allergen levels, pet ownership, cigarette smoke exposure, and parental history of asthma or allergy.
Study design
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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
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 23 Dec 2015.
- Background: PubMed 12762090Johnson CC, Ownby DR, Zoratti EM, Alford SH, Williams LK, Joseph CL. Environmental epidemiology of pediatric asthma and allergy. Epidemiol Rev. 2002;24(2):154-75. doi: 10.1093/epirev/mxf013. No abstract available.
- Background: PubMed 14767444Williams LK, Peterson EL, Ownby DR, Johnson CC. The relationship between early fever and allergic sensitization at age 6 to 7 years. J Allergy Clin Immunol. 2004 Feb;113(2):291-6. doi: 10.1016/j.jaci.2003.11.010.
- Background: PubMed 15536408Alford SH, Zoratti E, Peterson EL, Maliarik M, Ownby DR, Johnson CC. Parental history of atopic disease: disease pattern and risk of pediatric atopy in offspring. J Allergy Clin Immunol. 2004 Nov;114(5):1046-50. doi: 10.1016/j.jaci.2004.08.036.
- Background: PubMed 14612678Ownby DR, Johnson CC. Does exposure to dogs and cats in the first year of life influence the development of allergic sensitization? Curr Opin Allergy Clin Immunol. 2003 Dec;3(6):517-22. doi: 10.1097/00130832-200312000-00015.
- Background: PubMed 15940137Johnson CC, Ownby DR, Alford SH, Havstad SL, Williams LK, Zoratti EM, Peterson EL, Joseph CL. Antibiotic exposure in early infancy and risk for childhood atopy. J Allergy Clin Immunol. 2005 Jun;115(6):1218-24. doi: 10.1016/j.jaci.2005.04.020.
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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.
Dennis Ownby
Augusta University
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by Augusta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00037726, which also lists 5 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 23 Dec 2015.