Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics

NCT00252291 | Completed Phase 3

• 1 other identifier: DPM-A-305
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

bronchial; hyperresponsiveness

Outcome Measures

Primary Outcomes (2)

• Comparison of Aridol and exercise BHR tests

• Safety of Aridol test

Secondary Outcomes (2)

• Comparison of Aridol and methacholine test

• Comparison of Aridol test and clinical diagnosis

Interventions

Aridol DRUG

Methacholine DRUG

Exercise challenge PROCEDURE

Eligibility Criteria

• Age: 6 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Have given informed consent to participate in this study in accordance with local regulations prior to any procedures being performed
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Syntara: lead

Study Sites (1)

Colorado Asthma and Allergy Centers, 125 Rampart Way

Denver, Colorado, 80230-6405, United States

Location

Related Publications (4)

• 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.

  PMID: 9309990 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.

  PMID: 10738017 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.

  PMID: 12456381 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.

  PMID: 14555564 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Mannitol; Methacholine Chloride

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Methacholine Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Onium Compounds

Study Officials

• David Pearlman, MD

  Colorado Asthma and Allergy Centers, Denver, CO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 11, 2005
• Study Start: November 1, 2005
• Study Completion: September 1, 2006
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

US (1)