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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aridol | Drug | |||
| Methacholine | Drug | |||
| Exercise challenge | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Aridol and exercise BHR tests | ||
| Safety of Aridol test |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Aridol and methacholine test | ||
| Comparison of Aridol test and clinical diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Pearlman, MD | Colorado Asthma and Allergy Centers, Denver, CO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Asthma and Allergy Centers, 125 Rampart Way | Denver | Colorado | 80230-6405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9309990 | Background | 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. | |
| 10738017 | Background | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| D016210 | Methacholine Chloride |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| 12456381 | Background | 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. |
| 14555564 | Background | 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008688 |
| Methacholine Compounds |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009861 | Onium Compounds |