- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00252291
Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics
November 29, 2009 updated by: Pharmaxis
A Phase III Multicenter Study to Demonstrate the Sensitivity and Specificity of Aridol (Mannitol) Challenge to Predict Bronchial Hyperresponsiveness as Manifested by a Positive Exercise Challenge in Subjects Presenting With Signs and Symptoms Suggestive of Asthma But Without a Definitive Diagnosis
This is a Phase 3 study to determine the sensitivity and specificity of the Aridol bronchial challenge test to detect bronchial hyperresponsiveness in patients with suspected asthma.
Patients with suspected asthma of either gender, aged between 6 and 50 years, with only mildly impaired lung function (FEV1 >70%) are to be tested with three different bronchial hyperresponsiveness challenges (Aridol, exercise and methacholine), and the results compared.
A clinical diagnosis will also be made at the end of the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
240
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80230-6405
- Colorado Asthma and Allergy Centers, 125 Rampart Way
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have given informed consent to participate in this study in accordance with local regulations prior to any procedures being performed
- Have signs and symptoms suggestive of asthma according to the NIH Questionnaire but has not been given a firm diagnosis of asthma or a firm exclusion of the diagnosis of asthma (e.g. has an equivocal diagnosis of asthma or been referred for further investigation of asthma type symptoms)
- Have at least Step 1 symptoms according to the NAEPPII asthma severity grading
- Have an FEV1 ≥ 70% of the predicted value at Screening Visit (Visit 1) baseline
- Be between 6 and 50 years
- Be able to perform all of the techniques necessary to measure lung function including an exercise challenge, Aridol challenge and methacholine challenge
- Be able to understand the requirements of the study and be able to complete all of the forms necessary including the NIH Questionnaire
- Be taking effective birth control if female of childbearing potential
Exclusion Criteria:
- Use medications six weeks prior to the Screening Visit (Visit 1) or during the study that would interfere with bronchial provocation challenge testing (see Table 1, section 3.3.3.4)
- Currently use cholinesterase-inhibitor medication (for myasthenia gravis)
- Have had upper or lower respiratory tract infection within the previous 4 weeks
- Have known aortic or cerebral aneurysm, cirrhosis or portal hypertension
- Have had recent major surgery
- Have had recent cataract surgery
- Have a history of heart disease that would increase risk of performing exercise, methacholine or Aridol challenge
- Have had cardiac ischemia or malignant arrhythmias
- Have uncontrolled hypertension (systolic blood pressure ≥ 180 and diastolic blood pressure ≥ 100)
- Have orthopedic limitations
- Have smoked within the past year (average > 1 cigarette per week), or have a ≥ 10 pack year smoking history
- Have other chronic restrictive or obstructive pulmonary diseases (cystic fibrosis, COPD, bronchiectasis, chronic bronchitis, emphysema, tuberculosis, pulmonary carcinoma, pulmonary fibrosis, pulmonary hypertension, hypercapnia)
- Be skin test positive to seasonal and perennial aeroallergens that are present in the environment during the time that the subject is enrolled in the study, or if skin test positive to these aeroallergens the subject must not report worsening of symptoms when exposed to these aeroallergens during the time that the subject is participating in the study
- Have a medical condition that in the opinion of the Investigator would impair the ability of the subject to participate
- Have an inability to perform spirometry of acceptable quality
- Be intolerant to Aridol, methacholine or albuterol
- Be pregnant or lactating
- Have participated in any other investigative drug study parallel to, or within 4 weeks of study entry
- Be an Investigator, site employee or otherwise be directly affiliated with the study site including being a member of the immediate family of an Investigator, site employee (where an immediate family member is defined as spouse, parent, child or sibling, whether biological or legally adopted or in foster care)
- Have a body mass index (BMI) ≥ 30
- Have been diagnosed at Screening Visit (Visit 1) as definitively having or not having asthma; patients that will not continue in the study include those given the following diagnosis: asthma is extremely likely or definite (95 to 100% likelihood) or asthma is very unlikely or excluded (0 to < 5% likelihood)
- Have previously been enrolled in this study at this or at any other clinical trials site
- Have previously received an Aridol challenge
- Have a clinically significantly abnormal chest x-ray
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Comparison of Aridol and exercise BHR tests
|
Safety of Aridol test
|
Secondary Outcome Measures
Outcome Measure |
---|
Comparison of Aridol and methacholine test
|
Comparison of Aridol test and clinical diagnosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Pearlman, MD, Colorado Asthma and Allergy Centers, Denver, CO
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Anderson SD, Brannan J, Spring J, Spalding N, Rodwell LT, Chan K, Gonda I, Walsh A, Clark AR. A new method for bronchial-provocation testing in asthmatic subjects using a dry powder of mannitol. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):758-65. doi: 10.1164/ajrccm.156.3.9701113.
- Subbarao P, Brannan JD, Ho B, Anderson SD, Chan HK, Coates AL. Inhaled mannitol identifies methacholine-responsive children with active asthma. Pediatr Pulmonol. 2000 Apr;29(4):291-8. doi: 10.1002/(sici)1099-0496(200004)29:43.0.co;2-a.
- Holzer K, Anderson SD, Chan HK, Douglass J. Mannitol as a challenge test to identify exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Feb 15;167(4):534-7. doi: 10.1164/rccm.200208-916OC. Epub 2002 Nov 27.
- Koskela HO, Hyvarinen L, Brannan JD, Chan HK, Anderson SD. Sensitivity and validity of three bronchial provocation tests to demonstrate the effect of inhaled corticosteroids in asthma. Chest. 2003 Oct;124(4):1341-9. doi: 10.1378/chest.124.4.1341.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion
December 8, 2022
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
November 10, 2005
First Submitted That Met QC Criteria
November 10, 2005
First Posted (Estimate)
November 11, 2005
Study Record Updates
Last Update Posted (Estimate)
December 1, 2009
Last Update Submitted That Met QC Criteria
November 29, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Bronchial Hyperreactivity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Cholinergic Agonists
- Respiratory System Agents
- Miotics
- Parasympathomimetics
- Bronchoconstrictor Agents
- Muscarinic Agonists
- Methacholine Chloride
Other Study ID Numbers
- DPM-A-305
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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