Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics

This study has been completed.
Sponsor:
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00252291
First received: November 10, 2005
Last updated: November 29, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Aridol
Drug: Methacholine
Procedure: Exercise challenge
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • Comparison of Aridol and exercise BHR tests
  • Safety of Aridol test

Secondary Outcome Measures:
  • Comparison of Aridol and methacholine test
  • Comparison of Aridol test and clinical diagnosis

Estimated Enrollment: 240
Study Start Date: November 2005
Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   6 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have given informed consent to participate in this study in accordance with local regulations prior to any procedures being performed
  2. 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)
  3. Have at least Step 1 symptoms according to the NAEPPII asthma severity grading
  4. Have an FEV1 ≥ 70% of the predicted value at Screening Visit (Visit 1) baseline
  5. Be between 6 and 50 years
  6. Be able to perform all of the techniques necessary to measure lung function including an exercise challenge, Aridol challenge and methacholine challenge
  7. Be able to understand the requirements of the study and be able to complete all of the forms necessary including the NIH Questionnaire
  8. Be taking effective birth control if female of childbearing potential

Exclusion Criteria:

  1. 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)
  2. Currently use cholinesterase-inhibitor medication (for myasthenia gravis)
  3. Have had upper or lower respiratory tract infection within the previous 4 weeks
  4. Have known aortic or cerebral aneurysm, cirrhosis or portal hypertension
  5. Have had recent major surgery
  6. Have had recent cataract surgery
  7. Have a history of heart disease that would increase risk of performing exercise, methacholine or Aridol challenge
  8. Have had cardiac ischemia or malignant arrhythmias
  9. Have uncontrolled hypertension (systolic blood pressure ≥ 180 and diastolic blood pressure ≥ 100)
  10. Have orthopedic limitations
  11. Have smoked within the past year (average > 1 cigarette per week), or have a ≥ 10 pack year smoking history
  12. Have other chronic restrictive or obstructive pulmonary diseases (cystic fibrosis, COPD, bronchiectasis, chronic bronchitis, emphysema, tuberculosis, pulmonary carcinoma, pulmonary fibrosis, pulmonary hypertension, hypercapnia)
  13. 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
  14. Have a medical condition that in the opinion of the Investigator would impair the ability of the subject to participate
  15. Have an inability to perform spirometry of acceptable quality
  16. Be intolerant to Aridol, methacholine or albuterol
  17. Be pregnant or lactating
  18. Have participated in any other investigative drug study parallel to, or within 4 weeks of study entry
  19. 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)
  20. Have a body mass index (BMI) ≥ 30
  21. 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)
  22. Have previously been enrolled in this study at this or at any other clinical trials site
  23. Have previously received an Aridol challenge
  24. Have a clinically significantly abnormal chest x-ray
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252291

Locations
United States, Colorado
Colorado Asthma and Allergy Centers, 125 Rampart Way
Denver, Colorado, United States, 80230-6405
Sponsors and Collaborators
Pharmaxis
Investigators
Principal Investigator: David Pearlman, MD Colorado Asthma and Allergy Centers, Denver, CO
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00252291     History of Changes
Other Study ID Numbers: DPM-A-305
Study First Received: November 10, 2005
Last Updated: November 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmaxis:
bronchial
hyperresponsiveness

Additional relevant MeSH terms:
Asthma
Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014