AsthmaNCT00001887
Factors Involved in Asthma and Airway Inflammation
An observational study of Asthma and Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Asthma is the third leading cause of preventable admissions to the hospital in the United States. Deaths and diseases associated with asthma increase every year. Asthma is a disorder of airway inflammation. There are several factors thought to play a role in the process of inflammation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Feb 2001
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
ASTHMATICS:
Must be between 18 and 65 years of age, male or female, and must be at least 5 feet in height.
The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation. Patients will have mild-to-moderately severe asthma as defined by a baseline forced expiratory flow in one second (FEV(1)) greater than 70% of predicted (at least 6 hours after bronchodilator use) and therapy limited to inhaled beta-agonists.
Positive skin prick-puncture test to one or more common aeroallergens.
A positive inhaled methacholine challenge as defined by a decrease in FEV(1) of at least 20% (PC(20)) in response to inhalation of less than 25 mg/ml of methacholine.
A decrease in FEV(1) of at least 20% in response to inhalation of up to 10,000 bioequivalency allergy units (BAU) or allergy units (AU) per ml of a selected common aeroallergen (house dust mite, cat hair or grasses) or up to 150 Antigen E units per ml of short ragweed. Asthmatic patients must also demonstrate a late asthmatic response (defined as a 20% fall from the baseline established following completion of the early asthmatic response).
Normal complete blood count, PT, PTT, and serum electrolytes, mineral and hepatic panels (less than 30 ml of blood will be drawn), normal EKG and chest radiograph without acute pulmonary infiltrates.
Women of childbearing potential must have a negative pregnancy test within 2 weeks prior to study and willingness to adhere to reliable birth control methods during the study.
Must not have a diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic fibrosis, bronchiectasis, HIV-related lymphocytic airway inflammation).
Must not have a baseline FEV(1) of less than 70% predicted.
Must not have respiratory tract infection or asthma exacerbation within 4 weeks of screening.
Must not use theophylline, oral or inhaled corticosteroids, nedocromil sodium, cromolyn sodium, zilueton, leukotriene receptor antagonists (e.g., zafirlukast or montelukast), or anti-cholinergic agents within the prior 3 months. In addition, patients requiring ongoing therapy with anti-histamines, hydroxyzine, and tricyclic anti-depressants will be excluded. Research subjects can continue therapy with inhaled beta-agonists during the study.
No history of anaphylaxis or severe allergic response.
No history of adverse reactions to lidocaine or other local anesthetics.
No history of active inhaled or intravenous drug abuse or alcohol abuse.
Must not have an abnormal EKG or evidence of coronary artery disease.
Must not require chronic anti-coagulant therapy.
Must not use aspirin within 2 weeks of the bronchoscopic study or non-steroidal anti-inflammatory agents within 2 days of the bronchoscopic study.
No history of cigarette smoking within the past 3 years.
No history of allergy immunotherapy within the past year.
Not allergic to methacholine.
PT or PTT must not be prolonged 2 seconds greater than normal range.
Platelet count must be greater than or equal to 150,000/mm(3).
Must not test positive for human immunodeficiency virus.
RESEARCH VOLUNTEERS:
Must be between 18 and 65 years of age, male or female, and must be at least 5 feet in height.
A negative inhaled methacholine challenge as defined by the absence of a decrease in FEV(1) by 20% (PC(20)) in response to inhalation of 25 mg/ml of methacholine.
A negative skin test to a panel of common aeroallergens.
Normal complete blood count, PT, PTT, and serum electrolytes, mineral and hepatic panels (less than 30 ml of blood will be drawn). Negative hepatitis serology. Normal EKG and chest radiograph without acute pulmonary infiltrates.
Women of childbearing potential must have a negative pregnancy test within 2 weeks prior to study and willingness to adhere to reliable birth control methods during the study.
No history of asthma, allergic rhinitis, or atopic dermatitis.
Must not have a diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic fibrosis, bronchiectasis, HIV-related lymphocytic airway inflammation).
Must not have a baseline FEV(1) of less than 70% predicted.
Must not have respiratory tract infection or asthma exacerbation within 4 weeks of screening.
Must not use theophylline, oral or inhaled corticosteroids, nedocromil sodium, cromolyn sodium, zilueton, leukotriene receptor antagonists (e.g., zafirlukast or montelukast), or anti-cholinergic agents within the prior 3 months. In addition, patients requiring ongoing therapy with anti-histamines, hydroxyzine, and tricyclic anti-depressants will be excluded. Research subjects can continue therapy with inhaled beta-agonists during the study.
No history of anaphylaxis or severe allergic response.
No history of adverse reactions to lidocaine or other local anesthetics.
No history of active inhaled or intravenous drug abuse or alcohol abuse.
Must not have an abnormal EKG or evidence of coronary artery disease.
Must not require chronic anti-coagulant therapy.
Must not use aspirin within 2 weeks of the bronchoscopic study or non-steroidal anti-inflammatory agents within 2 days of the bronchoscopic study.
No history of cigarette smoking within the past 3 years.
No history of allergy immunotherapy within the past year.
Not allergic to methacholine.
PT or PTT must not be prolonged 2 seconds greater than normal range.
Platelet count must be greater than or equal to 150,000/mm(3).
Must not test positive for human immunodeficiency virus.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: The Role of a Novel Aminopeptidase-Like Protein in Asthma
Asthma is the third leading cause of preventable admissions to the hospital in the United States. Deaths and diseases associated with asthma increase every year. Asthma is a disorder of airway inflammation. There are several factors thought to play a role in the process of inflammation.
In this study researchers are particularly interested in studying a factors known as TNF (tumor necrosis factor) and the sites where this factor attaches called receptors. Another factor associated with receptor processing is called aminopeptidase-like protein. It may be involved in the relationship between TNF, it's receptors, and inflammation.
Read more
In order to understand the relationship between these factors, researchers plan to simulate an allergic reaction in the lungs and airways of patients participating in the study. By doing this they can collect and study the factors causing airway inflammation. Samples collected from patients with asthma will be compared to samples from volunteers without asthma.
Patients and volunteers participating in this study will not directly benefit from this research. However, the study may help researchers understand the causes and processes involved in asthma. In addition, the study may lead to the development of new treatments for asthma and airway inflammation.
Read the detailed description
The goal of this exploratory study is to assess the role of a novel aminopeptidase-like protein during the induction of airway inflammation in asthma. This aminopeptidase-like protein may be involved in processing of the type I TNF receptor to a soluble form. We propose to study the role of this aminopeptidase-like protein in the setting of late phase asthmatic airway inflammatory responses following segmental allergen challenge in mild allergic asthmatics.
- Keywords
- Airway Inflammation, Allergen Challenge, Bronchoscopy, Cytokines, Receptors, Asthma, Normal Volunteer
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMar 1999
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Enrolment
- 60 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001887
- Sponsor's protocol ID
- 990075
- Other IDs
- 99-H-0075
- Status last verified
- Feb 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Pappas G, Hadden WC, Kozak LJ, Fisher GF. Potentially avoidable hospitalizations: inequalities in rates between US socioeconomic groups. Am J Public Health. 1997 May;87(5):811-6. doi: 10.2105/ajph.87.5.811.
PubMed 9184511Smith DH, Malone DC, Lawson KA, Okamoto LJ, Battista C, Saunders WB. A national estimate of the economic costs of asthma. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):787-93. doi: 10.1164/ajrccm.156.3.9611072.
PubMed 9309994Azzawi M, Bradley B, Jeffery PK, Frew AJ, Wardlaw AJ, Knowles G, Assoufi B, Collins JV, Durham S, Kay AB. Identification of activated T lymphocytes and eosinophils in bronchial biopsies in stable atopic asthma. Am Rev Respir Dis. 1990 Dec;142(6 Pt 1):1407-13. doi: 10.1164/ajrccm/142.6_Pt_1.1407.
PubMed 2252260
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Novel Aminopeptidase-Like Protein in Asthma
- ClinicalTrials.gov ID
- NCT00001887
- Acronym / sponsor ID
- 990075
- Keywords
- Airway Inflammation, Allergen Challenge, Bronchoscopy, Cytokines, Receptors, Asthma, Normal Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Mar 1999
- Study completion
- Feb 2001
- First posted
- 10 Dec 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.
Asthma is the third leading cause of preventable admissions to the hospital in the United States. Deaths and diseases associated with asthma increase every year. Asthma is a disorder of airway inflammation. There are several factors thought to play a role in the process of inflammation.
In this study researchers are particularly interested in studying a factors known as TNF (tumor necrosis factor) and the sites where this factor attaches called receptors. Another factor associated with receptor processing is called aminopeptidase-like protein. It may be involved in the relationship between TNF, it's receptors, and inflammation.
In order to understand the relationship between these factors, researchers plan to simulate an allergic reaction in the lungs and airways of patients participating in the study. By doing this they can collect and study the factors causing airway inflammation. Samples collected from patients with asthma will be compared to samples from volunteers without asthma.
Patients and volunteers participating in this study will not directly benefit from this research. However, the study may help researchers understand the causes and processes involved in asthma. In addition, the study may lead to the development of new treatments for asthma and airway inflammation.
Detailed description
The goal of this exploratory study is to assess the role of a novel aminopeptidase-like protein during the induction of airway inflammation in asthma. This aminopeptidase-like protein may be involved in processing of the type I TNF receptor to a soluble form. We propose to study the role of this aminopeptidase-like protein in the setting of late phase asthmatic airway inflammatory responses following segmental allergen challenge in mild allergic asthmatics.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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 4 Mar 2008.
- Background: PubMed 9184511Pappas G, Hadden WC, Kozak LJ, Fisher GF. Potentially avoidable hospitalizations: inequalities in rates between US socioeconomic groups. Am J Public Health. 1997 May;87(5):811-6. doi: 10.2105/ajph.87.5.811.
- Background: PubMed 9309994Smith DH, Malone DC, Lawson KA, Okamoto LJ, Battista C, Saunders WB. A national estimate of the economic costs of asthma. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):787-93. doi: 10.1164/ajrccm.156.3.9611072.
- Background: PubMed 2252260Azzawi M, Bradley B, Jeffery PK, Frew AJ, Wardlaw AJ, Knowles G, Assoufi B, Collins JV, Durham S, Kay AB. Identification of activated T lymphocytes and eosinophils in bronchial biopsies in stable atopic asthma. Am Rev Respir Dis. 1990 Dec;142(6 Pt 1):1407-13. doi: 10.1164/ajrccm/142.6_Pt_1.1407.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Asthma and Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001887, which also lists 3 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 4 Mar 2008.