AsthmaAMPHisNCT02318043

AMP-BPT and His-BPT for Assessment of Asthma

A study testing inhaled corticosteroids (usually budesonide/fomorterol 160/4.5mcg; fluticasone/salmeterol 250/50mcg) in people with Asthma, run by Guangzhou Institute of Respiratory Disease.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Adenosine monophosphate (AMP) may reflect airway inflammation and hyperresponsiveness, but relationship between AMP and histamine (His, a conventional stimulus) bronchial provocation test (BPT) in asthma is not fully elucidated. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
What is being tested?: inhaled corticosteroids (usually budesonide/fomorterol 160/4.5mcg; fluticasone/salmeterol 250/50mcg)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: No sites listed yet
Study dates: Jan 2007to Dec 2007
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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

aged 18~65 years;
nil respiratory infection within 3 weeks;
normal chest radiography;
baseline FEV1>60% predicted;
withdrawn from, if any, oral leukotriene modifiers, corticosteroid or anti-histamine for 5 days, oral xanthenes or long-acting bronchodilators for 2 days, inhaled corticosteroids (ICSs) for 24 hours, and salbutamol for 6 hours

Who cannot join

FEV1 fall ≥20% following saline inhalation;
other chronic lower respiratory diseases (i.e. COPD);
severe systemic diseases (i.e. uncontrolled hypertension, malignancy);
limited understanding.
For healthy subjects, they had to be aged 18~65 years and had nil respiratory infection within 3 weeks, systemic diseases and had normal lung function.

About this study

Official title: Is Adenosine Monophosphate Superior to Histamine for Bronchial Provocation Test in Evaluation of Asthma?

The investigators aimed to compare both BPTs and determine their usefulness in reflecting changes of asthmatic symptoms.

BPTs were performed in cross-over fashion, at 2-4day intervals. Cumulative doses eliciting 20% FEV1fall (PD20FEV1), diagnostic performance and adverse events were compared. Patients with PD20FEV1 lower than geometric mean were defined as responders, otherwise poor responders. Patients with uncontrolled and partly controlled asthma, who maintained their original inhaled corticosteroids therapy, underwent reassessment of airway responsiveness and asthmatic symptoms 3 and 6 months after.

Read the detailed description

Airway hyperresponsiveness, the pivotal feature of asthma, can be assessed by bronchial provocation tests (BPTs), which may elicit bronchoconstriction via inhalation of stimuli. Histamine has been a direct stimulus for inducing bronchoconstriction via vasodilation, eosinophil chemotaxis and tissue edema. Clinically, histamine BPT (His-BPT) has gained extensive application for decades owing to the assay sensitivity and feasibility, but could not ideally predict anti-inflammatory treatment outcomes in practice. Additionally, mild adverse events (flushing and hoarseness) and insufficient capacity of identifying exercise-induced asthma have hampered further clinical applications.

Adenosine monophosphate (AMP) is an inflammatory mediator that serves as an indirect bronchial stimulus for detecting airway hyperresponsiveness in asthma. Compared with histamine, AMP may be pathophysiologically more relevant to airway inflammation and hyperresponsiveness and has been linked to presence and magnitude of atopy. However, differences of response to AMP-BPT and His-BPT in different asthma control levels and their associations with asthmatic symptom scores have not been fully elucidated.

We hypothesized that asthmatic patients, regardless of control levels, responded differentially to AMP-BPT and His-BPT, and that greater reduction in airway responsiveness to AMP (esp. responders of AMP-BPT) was associated with significant symptom alleviation. Henceforth, we sought to: 1) compare diagnostic performance and safety of AMP-BPT and His-BPT in different asthma control levels; 2) determine the association between airway responsiveness and asthmatic symptom scores.

Currently, His-BPT is recommended by the Chinese guideline and shares considerable similarity with methacholine (another conventional stimulus) BPT, we therefore did not perform the latter in this study.

Conditions: Asthma
Being tested: inhaled corticosteroids (usually budesonide/fomorterol 160/4.5mcg; fluticasone/salmeterol 250/50mcg)
Keywords: adenosine monophosphate, histamine, bronchial provocation test, asthma symptom score, asthma control
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

inhaled corticosteroids (usually budesonide/fomorterol 160/4.5mcg; fluticasone/salmeterol 250/50mcg)Drug
Patients with uncontrolled and partly controlled asthma, following accomplishment of study 1, were invited to participate in observational study (study 2), which sought to determine usefulness of both BPTs in reflecting improvement of asthmatic symptoms following 3 and 6 months of moderate-dose ICSs treatment (400~800μg budesonide or equivalent). Patient continued to administer their original ICS during follow-up. During two follow-up visits (3 months apart), AMP-BPT, His-BPT and Hogg's symptom scores were reassessed.

Study groups in NCT02318043
Study group	Role	What they receive
AMP-BPT	Active comparator	Methods of AMP-BPT, by applying dosimeters, resembled that reported previously [see references 21-25]. Briefly, dilutions were delivered via nebulizers (output: 160 μl/min) using automated APS pro system (JAEGER, Hochburg, Germany). Inhalation challenge with normal saline served as control step. Challenge steps were proceeded if FEV1 fall <15% and restored to <10% within 1 minute. Subsequent inhalation challenges were performed at 1-minute intervals, and ceased when FEV1 fell by ≥20%. Salbutamol was administered via spacer (Volumatic, Allen \& Hanbury's, UK). Spirometry was reexamined at minutes 3, 5, 10 and thereafter, to ensure safety, before discharge. Receives: Drug: inhaled corticosteroids (usually budesonide/fomorterol 160/4.5mcg; fluticasone/salmeterol 250/50mcg)
His-BPT	Active comparator	Methods of His-BPT, by applying dosimeters, resembled that reported previously [see references 21-25]. Briefly, dilutions were delivered via nebulizers (output: 160 μl/min) using automated APS pro system (JAEGER, Hochburg, Germany). Inhalation challenge with normal saline served as control step. Challenge steps were proceeded if FEV1 fall <15% and restored to <10% within 1 minute. Subsequent inhalation challenges were performed at 1-minute intervals, and ceased when FEV1 fell by ≥20%. Salbutamol was administered via spacer (Volumatic, Allen \& Hanbury's, UK). Spirometry was reexamined at minutes 3, 5, 10 and thereafter, to ensure safety, before discharge. Receives: Drug: inhaled corticosteroids (usually budesonide/fomorterol 160/4.5mcg; fluticasone/salmeterol 250/50mcg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative dose eliciting 20% fall in FEV1 (PD20FEV1)
Cumulative dose eliciting 20% fall in FEV1 (PD20FEV1), reported as
Measured: up to 12 months (Jan 2007 to Dec 2007)
Asthma symptom score as proposed by Hoggs et al
Asthma symptom score recorded within 1 week, with the highest possible score of 42 for the whole week
Measured: up to 12 months (Jan 2007 to Dec 2007)

Secondary outcomes (9)

Baseline spirometry (FVC, FEV1, FEV1/FVC, MMEF, PEF)
FVC, FEV1, FEV1/FVC, MMEF, PEF
Measured: up to 12 months (Jan 2007 to Dec 2007)
Maximal decrease in FVC following bronchial provocation (expressed as percentage)
Maximal decrease in FVC following bronchial provocation, expressed as percentage as compared with baseline levels
Measured: up to 12 months (Jan 2007 to Dec 2007)
Maximal decrease in FEV1 following bronchial provocation (expressed as percentage)
Maximal decrease in FEV1 following bronchial provocation, expressed as percentage as compared with baseline levels
Measured: up to 12 months (Jan 2007 to Dec 2007)
Maximal decrease in MMEF following bronchial provocation (expressed as percentage)
Maximal decrease in MMEF following bronchial provocation, expressed as percentage as compared with baseline levels
Measured: up to 12 months (Jan 2007 to Dec 2007)
Maximal decrease in PEF following bronchial provocation (expressed as percentage)
Maximal decrease in PEF following bronchial provocation, expressed as percentage as compared with baseline levels
Measured: up to 12 months (Jan 2007 to Dec 2007)
Assay positivity of AMP-BPT and His-BPT (expressed as percentage)
Assay positivity of AMP-BPT and His-BPT, expressed as percentage
Measured: up to 12 months (Jan 2007 to Dec 2007)
Diagnostic performance of AMP-BPT and His-BPT (area under the receiver operation characteristic curve, sensitivity, specificity, Youden index)
area under the receiver operation characteristic curve, sensitivity, specificity, Youden index
Measured: up to 12 months (Jan 2007 to Dec 2007)
Changes in post-treatment asthma symptom scores
post-treatment minus pre-treatment asthma symptom score
Measured: up to 12 months (Jan 2007 to Dec 2007)
Changes in post-treatment PD20FEV1
post-treatment minus pre-treatment PD20FEV1
Measured: up to 12 months (Jan 2007 to Dec 2007)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Dec 2007

First posted17 Dec 2014 (estimated)
Study startJan 2007
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02318043
Sponsor's protocol ID: GWJ
Acronym: AMPHis
Status last verified: Dec 2014
First submitted: 7 Dec 2014
Last updated: 17 Dec 2014
Results posted: No
Data monitoring committee: No

Publications

O'Byrne PM, Inman MD. Airway hyperresponsiveness. Chest. 2003 Mar;123(3 Suppl):411S-6S. doi: 10.1378/chest.123.3_suppl.411s.
PubMed 12629006
Hanania NA. Targeting airway inflammation in asthma: current and future therapies. Chest. 2008 Apr;133(4):989-98. doi: 10.1378/chest.07-0829.
PubMed 18398119
Leuppi JD. Bronchoprovocation tests in asthma: direct versus indirect challenges. Curr Opin Pulm Med. 2014 Jan;20(1):31-6. doi: 10.1097/MCP.0000000000000009.
PubMed 24275928
Janssens T, Verleden G, De Peuter S, Petersen S, Van den Bergh O. Predicting asthma treatment outcome at diagnosis: the role of symptom perception during a histamine challenge test. J Asthma. 2012 Apr;49(3):230-6. doi: 10.3109/02770903.2012.656864. Epub 2012 Feb 9.
PubMed 22316110
Dor A, Liebhart J, Malolepszy J. [Comparison of exercise and histamine provocation tests in patients with bronchial asthma]. Pneumonol Alergol Pol. 1999;67(1-2):22-7. Polish.
PubMed 10481521
Driver AG, Kukoly CA, Ali S, Mustafa SJ. Adenosine in bronchoalveolar lavage fluid in asthma. Am Rev Respir Dis. 1993 Jul;148(1):91-7. doi: 10.1164/ajrccm/148.1.91.
PubMed 8317821
Ali S, Mustafa SJ, Driver AG, Metzger WJ. Release of adenosine in bronchoalveolar lavage fluid following allergen bronchial provocation in allergic rabbits. Am Rev Respir Dis 1991;143:A417
Polosa R, Ng WH, Crimi N, Vancheri C, Holgate ST, Church MK, Mistretta A. Release of mast-cell-derived mediators after endobronchial adenosine challenge in asthma. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):624-9. doi: 10.1164/ajrccm/151.3_Pt_1.624.
PubMed 7881647
van den Berge M, Kerstjens HA, Meijer RJ, de Reus DM, Koeter GH, Kauffman HF, Postma DS. Corticosteroid-induced improvement in the PC20 of adenosine monophosphate is more closely associated with reduction in airway inflammation than improvement in the PC20 of methacholine. Am J Respir Crit Care Med. 2001 Oct 1;164(7):1127-32. doi: 10.1164/ajrccm.164.7.2102135.
PubMed 11673197
De Meer G, Heederik D, Postma DS. Bronchial responsiveness to adenosine 5'-monophosphate (AMP) and methacholine differ in their relationship with airway allergy and baseline FEV(1). Am J Respir Crit Care Med. 2002 Feb 1;165(3):327-31. doi: 10.1164/ajrccm.165.3.2104066.
PubMed 11818315
Suh DI, Lee JK, Kim CK, Koh YY. Bronchial hyperresponsiveness to methacholine and adenosine 5'-monophosphate, and the presence and degree of atopy in young children with asthma. Clin Exp Allergy. 2011 Mar;41(3):338-45. doi: 10.1111/j.1365-2222.2010.03664.x. Epub 2011 Jan 24.
PubMed 21255136
Suh DI, Lee JK, Kim CK, Koh YY. Methacholine and adenosine 5'-monophosphate (AMP) responsiveness, and the presence and degree of atopy in children with asthma. Pediatr Allergy Immunol. 2011 Feb;22(1 Pt 2):e101-6. doi: 10.1111/j.1399-3038.2010.01110.x.
PubMed 21342276
Kim CK, Choi SJ, Lee JK, Suh DI, Koh YY. Bronchial hyperresponsiveness to methacholine and adenosine monophosphate and the degree of atopy in children with allergic rhinitis. Ann Allergy Asthma Immunol. 2011 Jan;106(1):36-41. doi: 10.1016/j.anai.2010.10.019.
PubMed 21195943
The Respiratory Society of the Chinese Medical Association. Guidelines for lung function testing (Part 3): Histamine and methacholine bronchial provocation test. Zhonghua Jie He He Hu Xi Za Zhi 2014; 37:566-71
O'Byrne P, Bateman ED, Bousquet JD. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. Updated 2006. Available at http://www.ginasthma.org/Guidelines/guidelines-resources.html Latest accessed: Sep 20, 2014

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Is Adenosine Monophosphate Superior to Histamine for Bronchial Provocation Test in Evaluation of Asthma?
ClinicalTrials.gov ID: NCT02318043
Acronym / sponsor ID: AMPHis / GWJ
Conditions: Asthma
Keywords: adenosine monophosphate, histamine, bronchial provocation test, asthma symptom score, asthma control
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
Study start: Jan 2007
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 17 Dec 2014 (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 investigators aimed to compare both BPTs and determine their usefulness in reflecting changes of asthmatic symptoms.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AMP-BPT	Active comparator	Drug: inhaled corticosteroids (usually budesonide/fomorterol 160/4.5mcg; fluticasone/salmeterol 250/50mcg)Methods of AMP-BPT, by applying dosimeters, resembled that reported previously [see references 21-25]. Briefly, dilutions were delivered via nebulizers (output: 160 μl/min) using automated APS pro system (JAEGER, Hochburg, Germany). Inhalation challenge with normal saline served as control step. Challenge steps were proceeded if FEV1 fall <15% and restored to <10% within 1 minute. Subsequent inhalation challenges were performed at 1-minute intervals, and ceased when FEV1 fell by ≥20%. Salbutamol was administered via spacer (Volumatic, Allen \& Hanbury's, UK). Spirometry was reexamined at minutes 3, 5, 10 and thereafter, to ensure safety, before discharge.
His-BPT	Active comparator	Drug: inhaled corticosteroids (usually budesonide/fomorterol 160/4.5mcg; fluticasone/salmeterol 250/50mcg)Methods of His-BPT, by applying dosimeters, resembled that reported previously [see references 21-25]. Briefly, dilutions were delivered via nebulizers (output: 160 μl/min) using automated APS pro system (JAEGER, Hochburg, Germany). Inhalation challenge with normal saline served as control step. Challenge steps were proceeded if FEV1 fall <15% and restored to <10% within 1 minute. Subsequent inhalation challenges were performed at 1-minute intervals, and ceased when FEV1 fell by ≥20%. Salbutamol was administered via spacer (Volumatic, Allen \& Hanbury's, UK). Spirometry was reexamined at minutes 3, 5, 10 and thereafter, to ensure safety, before discharge.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

aged 18~65 years;
nil respiratory infection within 3 weeks;
normal chest radiography;
baseline FEV1>60% predicted;
withdrawn from, if any, oral leukotriene modifiers, corticosteroid or anti-histamine for 5 days, oral xanthenes or long-acting bronchodilators for 2 days, inhaled corticosteroids (ICSs) for 24 hours, and salbutamol for 6 hours

Key exclusion criteria (5 listed)

FEV1 fall ≥20% following saline inhalation;
other chronic lower respiratory diseases (i.e. COPD);
severe systemic diseases (i.e. uncontrolled hypertension, malignancy);
limited understanding.
For healthy subjects, they had to be aged 18~65 years and had nil respiratory infection within 3 weeks, systemic diseases and had normal lung function.

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
inhaled corticosteroids (usually budesonide/fomorterol 160/4.5mcg; fluticasone/salmeterol 250/50mcg)Patients with uncontrolled and partly controlled asthma, following accomplishment of study 1, were invited to participate in observational study (study 2), which sought to determine usefulness of both BPTs in reflecting improvement of asthmatic symptoms following 3 and 6 months of moderate-dose ICSs treatment (400~800μg budesonide or equivalent). Patient continued to administer their original ICS during follow-up. During two follow-up visits (3 months apart), AMP-BPT, His-BPT and Hogg's symptom scores were reassessed.	Drug	AMP-BPT, His-BPT

Primary outcome

Cumulative dose eliciting 20% fall in FEV1 (PD20FEV1)
Time frame: up to 12 months (Jan 2007 to Dec 2007)
Cumulative dose eliciting 20% fall in FEV1 (PD20FEV1), reported as
Asthma symptom score as proposed by Hoggs et al
Time frame: up to 12 months (Jan 2007 to Dec 2007)
Asthma symptom score recorded within 1 week, with the highest possible score of 42 for the whole week

9 secondary outcomes

Baseline spirometry (FVC, FEV1, FEV1/FVC, MMEF, PEF)
Time frame: up to 12 months (Jan 2007 to Dec 2007)
Maximal decrease in FVC following bronchial provocation (expressed as percentage)
Time frame: up to 12 months (Jan 2007 to Dec 2007)
Maximal decrease in FEV1 following bronchial provocation (expressed as percentage)
Time frame: up to 12 months (Jan 2007 to Dec 2007)
Maximal decrease in MMEF following bronchial provocation (expressed as percentage)
Time frame: up to 12 months (Jan 2007 to Dec 2007)
Maximal decrease in PEF following bronchial provocation (expressed as percentage)
Time frame: up to 12 months (Jan 2007 to Dec 2007)
Assay positivity of AMP-BPT and His-BPT (expressed as percentage)
Time frame: up to 12 months (Jan 2007 to Dec 2007)
Diagnostic performance of AMP-BPT and His-BPT (area under the receiver operation characteristic curve, sensitivity, specificity, Youden index)
Time frame: up to 12 months (Jan 2007 to Dec 2007)
Changes in post-treatment asthma symptom scores
Time frame: up to 12 months (Jan 2007 to Dec 2007)
Changes in post-treatment PD20FEV1
Time frame: up to 12 months (Jan 2007 to Dec 2007)

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 17 Dec 2014.
Background: PubMed 12629006O'Byrne PM, Inman MD. Airway hyperresponsiveness. Chest. 2003 Mar;123(3 Suppl):411S-6S. doi: 10.1378/chest.123.3_suppl.411s.
Background: PubMed 18398119Hanania NA. Targeting airway inflammation in asthma: current and future therapies. Chest. 2008 Apr;133(4):989-98. doi: 10.1378/chest.07-0829.
Background: PubMed 24275928Leuppi JD. Bronchoprovocation tests in asthma: direct versus indirect challenges. Curr Opin Pulm Med. 2014 Jan;20(1):31-6. doi: 10.1097/MCP.0000000000000009.
Background: PubMed 22316110Janssens T, Verleden G, De Peuter S, Petersen S, Van den Bergh O. Predicting asthma treatment outcome at diagnosis: the role of symptom perception during a histamine challenge test. J Asthma. 2012 Apr;49(3):230-6. doi: 10.3109/02770903.2012.656864. Epub 2012 Feb 9.
Background: PubMed 10481521Dor A, Liebhart J, Malolepszy J. [Comparison of exercise and histamine provocation tests in patients with bronchial asthma]. Pneumonol Alergol Pol. 1999;67(1-2):22-7. Polish.
Background: PubMed 8317821Driver AG, Kukoly CA, Ali S, Mustafa SJ. Adenosine in bronchoalveolar lavage fluid in asthma. Am Rev Respir Dis. 1993 Jul;148(1):91-7. doi: 10.1164/ajrccm/148.1.91.
BackgroundAli S, Mustafa SJ, Driver AG, Metzger WJ. Release of adenosine in bronchoalveolar lavage fluid following allergen bronchial provocation in allergic rabbits. Am Rev Respir Dis 1991;143:A417
Background: PubMed 7881647Polosa R, Ng WH, Crimi N, Vancheri C, Holgate ST, Church MK, Mistretta A. Release of mast-cell-derived mediators after endobronchial adenosine challenge in asthma. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):624-9. doi: 10.1164/ajrccm/151.3_Pt_1.624.
Background: PubMed 11673197van den Berge M, Kerstjens HA, Meijer RJ, de Reus DM, Koeter GH, Kauffman HF, Postma DS. Corticosteroid-induced improvement in the PC20 of adenosine monophosphate is more closely associated with reduction in airway inflammation than improvement in the PC20 of methacholine. Am J Respir Crit Care Med. 2001 Oct 1;164(7):1127-32. doi: 10.1164/ajrccm.164.7.2102135.
Background: PubMed 11818315De Meer G, Heederik D, Postma DS. Bronchial responsiveness to adenosine 5'-monophosphate (AMP) and methacholine differ in their relationship with airway allergy and baseline FEV(1). Am J Respir Crit Care Med. 2002 Feb 1;165(3):327-31. doi: 10.1164/ajrccm.165.3.2104066.
Background: PubMed 21255136Suh DI, Lee JK, Kim CK, Koh YY. Bronchial hyperresponsiveness to methacholine and adenosine 5'-monophosphate, and the presence and degree of atopy in young children with asthma. Clin Exp Allergy. 2011 Mar;41(3):338-45. doi: 10.1111/j.1365-2222.2010.03664.x. Epub 2011 Jan 24.
Background: PubMed 21342276Suh DI, Lee JK, Kim CK, Koh YY. Methacholine and adenosine 5'-monophosphate (AMP) responsiveness, and the presence and degree of atopy in children with asthma. Pediatr Allergy Immunol. 2011 Feb;22(1 Pt 2):e101-6. doi: 10.1111/j.1399-3038.2010.01110.x.

Related trials for Asthma

RecruitingPhase 1
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Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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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.

Questions about this trial

What is this clinical trial studying?

A study testing inhaled corticosteroids (usually budesonide/fomorterol 160/4.5mcg; fluticasone/salmeterol 250/50mcg) in people with Asthma, run by Guangzhou Institute of Respiratory Disease.

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 5 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 17 Dec 2014. 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.

What does the primary outcome measure?

Cumulative dose eliciting 20% fall in FEV1 (PD20FEV1) (time frame: up to 12 months (Jan 2007 to Dec 2007)). The study lists 2 primary outcomes in all. 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 NCT02318043, which also lists 25 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 17 Dec 2014.