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AsthmaPhase 3NCT00252291

Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics

A Phase 3 study testing Aridol, Methacholine and Exercise challenge in people with Asthma, run by Syntara at 1 site in United States.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 50 years
Conditions the study is for
Asthma
What is being tested?
Aridol, Methacholine and Exercise challenge
Type of treatment
Surgery or procedure
How many people
240 participants
Where
1 siteUnited States
Study dates
Nov 2005to Sep 2006
Phase
Phase 3
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 6 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Colorado Asthma and Allergy Centers, 125 Rampart Way

    Denver, Colorado, 80230-6405

Other trials in United States

About this study

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

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
Being tested
Aridol, Methacholine, Exercise challenge
Keywords
bronchial, hyperresponsiveness
Medical subject headings
Asthma

What participants receive

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

  • AridolDrug

  • MethacholineDrug

  • Exercise challengeProcedure or surgery

What is being measured

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

  1. Comparison of Aridol and exercise BHR tests

  2. Safety of Aridol test

Secondary outcomes (2)

  1. Comparison of Aridol and methacholine test

  2. Comparison of Aridol test and clinical diagnosis

Timeline

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

  1. First posted11 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Study completionSep 2006

Resources

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 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Enrolment
240 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00252291
Sponsor's protocol ID
DPM-A-305
Status last verified
Nov 2009
First submitted
10 Nov 2005
Last updated
1 Dec 2009
Results posted
No

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.

    PubMed 9309990

  • 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.

    PubMed 10738017

  • 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.

    PubMed 12456381

  • 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.

    PubMed 14555564

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aridol, Methacholine and Exercise challenge in people with Asthma, run by Syntara at 1 site in United States.

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 8 inclusion and 24 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 1 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Comparison of Aridol and exercise BHR tests. 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 NCT00252291, which also lists 4 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 1 Dec 2009.

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