AsthmaNCT00005475
Longitudinal Study of Asthma From Birth to Adulthood
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To extend follow-up of a birth cohort of asthmatic children through adolescence and on to adulthood. . Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1996to Jul 2006
- 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 22 years
- All sexes
- No healthy volunteers
- Child, Adult
No eligibility criteria
About this study
To extend follow-up of a birth cohort of asthmatic children through adolescence and on to adulthood. .
Read the detailed description
BACKGROUND:
The population under study is the cohort from Tucson Children's Respiratory Study (CRS), which began in 1980.
DESIGN NARRATIVE:
The longitudinal study follows a birth cohort of children, initially established in the 1980s. The study period took the children through their 16th birthday, when a comprehensive respiratory and allergy assessment was conducted. This extended follow-up took the cohort from birth to an age at which lung growth is virtually complete for girls and ending its most rapid phase for boys.
The resulting data set was used to test diverse hypotheses concerned with lower respiratory tract illnesses (LRI), asthma, wheezing, allergy, and smoking. There were four broad areas: 1) effects of LRI during the first three years of life and early and late symptoms and allergic sensitization on the picture of asthma; 2) changes during adolescence in symptoms and airways responsiveness; 3) the natural history of allergic sensitization and its relation to asthma and asthma-like symptoms; and 4) the change in longitudinal lung function and factors affecting the change.
A well documented data set was available to test these hypotheses. LRI were documented during the first three years of life, atopy was evaluated, symptom status tracked, and lung function periodically measured. Infant lung function was assessed for a sample of the children and methacholine challenge was performed at age 11. In the evaluation at age 16 years, symptoms, lung function, including methacholine responsiveness, and atopy and lymphocyte phenotype were assessed. Various methods for longitudinal data analysis were used.
The study was renewed in 2001 to follow the birth cohort into early adulthood in order to generate data on the mechanisms and risk factors associated with asthma in early adult life. Specifically the study will: 1) identify factors that alter persistence and remission of asthma symptoms among young adults who developed asthma in childhood; 2) assess the role of persistent eosinophilia during childhood as a mechanism which determines progression and incidence of asthma in early adult life, and prevalence of persistent bronchial hyperresponsiveness (BHR); 3) measure noninvasive markers of airway inflammation in early adult life, and identify correlates of these markers, both with childhood and current asthma symptoms, BHR and immune system indicators of allergy; 4) predict early (by age 20 ) decline in lung function with reference to childhood lower respiratory tract illnesses, asthma-like symptoms, and the initiation of smoking; and 5) investigate the role of gender in incidence of and risk factors for asthma during adolescence and young adult life.
- 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 posted26 May 2000 (estimated)
- Study startAug 1996
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Sponsor type
- US National Institutes of Health
- Investigators
- Fernando Martinez, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005475
- Sponsor's protocol ID
- 4959
- Other IDs
- R01HL056177
- Status last verified
- May 2009
- First submitted
- 25 May 2000
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Graves PE, Kabesch M, Halonen M, Holberg CJ, Baldini M, Fritzsch C, Weiland SK, Erickson RP, von Mutius E, Martinez FD. A cluster of seven tightly linked polymorphisms in the IL-13 gene is associated with total serum IgE levels in three populations of white children. J Allergy Clin Immunol. 2000 Mar;105(3):506-13. doi: 10.1067/mai.2000.104940.
PubMed 10719301Martinez FD, Holt PG. Role of microbial burden in aetiology of allergy and asthma. Lancet. 1999 Sep;354 Suppl 2:SII12-5. doi: 10.1016/s0140-6736(99)90437-3. No abstract available.
PubMed 10507253Wright AL, Sherrill D, Holberg CJ, Halonen M, Martinez FD. Breast-feeding, maternal IgE, and total serum IgE in childhood. J Allergy Clin Immunol. 1999 Sep;104(3 Pt 1):589-94. doi: 10.1016/s0091-6749(99)70328-3.
PubMed 10482832Stein RT, Sherrill D, Morgan WJ, Holberg CJ, Halonen M, Taussig LM, Wright AL, Martinez FD. Respiratory syncytial virus in early life and risk of wheeze and allergy by age 13 years. Lancet. 1999 Aug 14;354(9178):541-5. doi: 10.1016/S0140-6736(98)10321-5.
PubMed 10470697Halonen M, Stern DA, Lohman C, Wright AL, Brown MA, Martinez FD. Two subphenotypes of childhood asthma that differ in maternal and paternal influences on asthma risk. Am J Respir Crit Care Med. 1999 Aug;160(2):564-70. doi: 10.1164/ajrccm.160.2.9809038.
PubMed 10430729Sherrill DL, Stein R, Halonen M, Holberg CJ, Wright A, Martinez FD. Total serum IgE and its association with asthma symptoms and allergic sensitization among children. J Allergy Clin Immunol. 1999 Jul;104(1):28-36. doi: 10.1016/s0091-6749(99)70110-7.
PubMed 10400836Castro-Rodriguez JA, Holberg CJ, Wright AL, Halonen M, Taussig LM, Morgan WJ, Martinez FD. Association of radiologically ascertained pneumonia before age 3 yr with asthmalike symptoms and pulmonary function during childhood: a prospective study. Am J Respir Crit Care Med. 1999 Jun;159(6):1891-7. doi: 10.1164/ajrccm.159.6.9811035.
PubMed 10351936Martinez FD. Gene by environment interactions in the development of asthma. Clin Exp Allergy. 1998 Nov;28 Suppl 5:21-5; discussion 26-8. doi: 10.1046/j.1365-2222.1998.028s5021.x.
PubMed 9988443Martinez FD, Stern DA, Wright AL, Taussig LM, Halonen M. Differential immune responses to acute lower respiratory illness in early life and subsequent development of persistent wheezing and asthma. J Allergy Clin Immunol. 1998 Dec;102(6 Pt 1):915-20. doi: 10.1016/s0091-6749(98)70328-8.
PubMed 9847431Martinez FD, Solomon S, Holberg CJ, Graves PE, Baldini M, Erickson RP. Linkage of circulating eosinophils to markers on chromosome 5q. Am J Respir Crit Care Med. 1998 Dec;158(6):1739-44. doi: 10.1164/ajrccm.158.6.9712040.
PubMed 9847261Stein RT, Holberg CJ, Morgan WJ, Wright AL, Lombardi E, Taussig L, Martinez FD. Peak flow variability, methacholine responsiveness and atopy as markers for detecting different wheezing phenotypes in childhood. Thorax. 1997 Nov;52(11):946-52. doi: 10.1136/thx.52.11.946.
PubMed 9487341Martinez FD, Graves PE, Baldini M, Solomon S, Erickson R. Association between genetic polymorphisms of the beta2-adrenoceptor and response to albuterol in children with and without a history of wheezing. J Clin Invest. 1997 Dec 15;100(12):3184-8. doi: 10.1172/JCI119874.
PubMed 9399966Lombardi E, Morgan WJ, Wright AL, Stein RT, Holberg CJ, Martinez FD. Cold air challenge at age 6 and subsequent incidence of asthma. A longitudinal study. Am J Respir Crit Care Med. 1997 Dec;156(6):1863-9. doi: 10.1164/ajrccm.156.6.9612066.
PubMed 9412567Wright AL, Holberg CJ, Taussig LM, Martinez FD. Factors influencing the relation of infant feeding to asthma and recurrent wheeze in childhood. Thorax. 2001 Mar;56(3):192-7. doi: 10.1136/thorax.56.3.192.
PubMed 11182011Wright AL, Holberg CJ, Taussig LM, Martinez F. Maternal asthma status alters relation of infant feeding to asthma in childhood. Adv Exp Med Biol. 2000;478:131-7. doi: 10.1007/0-306-46830-1_11.
PubMed 11065066
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Asthma From Birth to Adulthood
- ClinicalTrials.gov ID
- NCT00005475
- Acronym / sponsor ID
- 4959
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1996
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 26 May 2000 (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 extend follow-up of a birth cohort of asthmatic children through adolescence and on to adulthood. .
Detailed description
BACKGROUND:
The population under study is the cohort from Tucson Children's Respiratory Study (CRS), which began in 1980.
DESIGN NARRATIVE:
The longitudinal study follows a birth cohort of children, initially established in the 1980s. The study period took the children through their 16th birthday, when a comprehensive respiratory and allergy assessment was conducted. This extended follow-up took the cohort from birth to an age at which lung growth is virtually complete for girls and ending its most rapid phase for boys.
The resulting data set was used to test diverse hypotheses concerned with lower respiratory tract illnesses (LRI), asthma, wheezing, allergy, and smoking. There were four broad areas: 1) effects of LRI during the first three years of life and early and late symptoms and allergic sensitization on the picture of asthma; 2) changes during adolescence in symptoms and airways responsiveness; 3) the natural history of allergic sensitization and its relation to asthma and asthma-like symptoms; and 4) the change in longitudinal lung function and factors affecting the change.
A well documented data set was available to test these hypotheses. LRI were documented during the first three years of life, atopy was evaluated, symptom status tracked, and lung function periodically measured. Infant lung function was assessed for a sample of the children and methacholine challenge was performed at age 11. In the evaluation at age 16 years, symptoms, lung function, including methacholine responsiveness, and atopy and lymphocyte phenotype were assessed. Various methods for longitudinal data analysis were used.
The study was renewed in 2001 to follow the birth cohort into early adulthood in order to generate data on the mechanisms and risk factors associated with asthma in early adult life. Specifically the study will: 1) identify factors that alter persistence and remission of asthma symptoms among young adults who developed asthma in childhood; 2) assess the role of persistent eosinophilia during childhood as a mechanism which determines progression and incidence of asthma in early adult life, and prevalence of persistent bronchial hyperresponsiveness (BHR); 3) measure noninvasive markers of airway inflammation in early adult life, and identify correlates of these markers, both with childhood and current asthma symptoms, BHR and immune system indicators of allergy; 4) predict early (by age 20 ) decline in lung function with reference to childhood lower respiratory tract illnesses, asthma-like symptoms, and the initiation of smoking; and 5) investigate the role of gender in incidence of and risk factors for asthma during adolescence and young adult life.
Study design
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 29 Jul 2016.
- Background: PubMed 10719301Graves PE, Kabesch M, Halonen M, Holberg CJ, Baldini M, Fritzsch C, Weiland SK, Erickson RP, von Mutius E, Martinez FD. A cluster of seven tightly linked polymorphisms in the IL-13 gene is associated with total serum IgE levels in three populations of white children. J Allergy Clin Immunol. 2000 Mar;105(3):506-13. doi: 10.1067/mai.2000.104940.
- Background: PubMed 10507253Martinez FD, Holt PG. Role of microbial burden in aetiology of allergy and asthma. Lancet. 1999 Sep;354 Suppl 2:SII12-5. doi: 10.1016/s0140-6736(99)90437-3. No abstract available.
- Background: PubMed 10482832Wright AL, Sherrill D, Holberg CJ, Halonen M, Martinez FD. Breast-feeding, maternal IgE, and total serum IgE in childhood. J Allergy Clin Immunol. 1999 Sep;104(3 Pt 1):589-94. doi: 10.1016/s0091-6749(99)70328-3.
- Background: PubMed 10470697Stein RT, Sherrill D, Morgan WJ, Holberg CJ, Halonen M, Taussig LM, Wright AL, Martinez FD. Respiratory syncytial virus in early life and risk of wheeze and allergy by age 13 years. Lancet. 1999 Aug 14;354(9178):541-5. doi: 10.1016/S0140-6736(98)10321-5.
- Background: PubMed 10430729Halonen M, Stern DA, Lohman C, Wright AL, Brown MA, Martinez FD. Two subphenotypes of childhood asthma that differ in maternal and paternal influences on asthma risk. Am J Respir Crit Care Med. 1999 Aug;160(2):564-70. doi: 10.1164/ajrccm.160.2.9809038.
- Background: PubMed 10400836Sherrill DL, Stein R, Halonen M, Holberg CJ, Wright A, Martinez FD. Total serum IgE and its association with asthma symptoms and allergic sensitization among children. J Allergy Clin Immunol. 1999 Jul;104(1):28-36. doi: 10.1016/s0091-6749(99)70110-7.
- Background: PubMed 10351936Castro-Rodriguez JA, Holberg CJ, Wright AL, Halonen M, Taussig LM, Morgan WJ, Martinez FD. Association of radiologically ascertained pneumonia before age 3 yr with asthmalike symptoms and pulmonary function during childhood: a prospective study. Am J Respir Crit Care Med. 1999 Jun;159(6):1891-7. doi: 10.1164/ajrccm.159.6.9811035.
- Background: PubMed 9988443Martinez FD. Gene by environment interactions in the development of asthma. Clin Exp Allergy. 1998 Nov;28 Suppl 5:21-5; discussion 26-8. doi: 10.1046/j.1365-2222.1998.028s5021.x.
- Background: PubMed 9847431Martinez FD, Stern DA, Wright AL, Taussig LM, Halonen M. Differential immune responses to acute lower respiratory illness in early life and subsequent development of persistent wheezing and asthma. J Allergy Clin Immunol. 1998 Dec;102(6 Pt 1):915-20. doi: 10.1016/s0091-6749(98)70328-8.
- Background: PubMed 9847261Martinez FD, Solomon S, Holberg CJ, Graves PE, Baldini M, Erickson RP. Linkage of circulating eosinophils to markers on chromosome 5q. Am J Respir Crit Care Med. 1998 Dec;158(6):1739-44. doi: 10.1164/ajrccm.158.6.9712040.
- Background: PubMed 9487341Stein RT, Holberg CJ, Morgan WJ, Wright AL, Lombardi E, Taussig L, Martinez FD. Peak flow variability, methacholine responsiveness and atopy as markers for detecting different wheezing phenotypes in childhood. Thorax. 1997 Nov;52(11):946-52. doi: 10.1136/thx.52.11.946.
- Background: PubMed 9399966Martinez FD, Graves PE, Baldini M, Solomon S, Erickson R. Association between genetic polymorphisms of the beta2-adrenoceptor and response to albuterol in children with and without a history of wheezing. J Clin Invest. 1997 Dec 15;100(12):3184-8. doi: 10.1172/JCI119874.
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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.
Fernando Martinez
University of Arizona
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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 29 Jul 2016. 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 NCT00005475, which also lists 36 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 29 Jul 2016.