NCT00252291 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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. Epub 2002 Nov 27.
Koskela HO, Hyvärinen 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.
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.

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

Details for clinical trial NCT00252291

Clinical trial NCT00252291 - References