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Phase 2 N=301 Randomized Quadruple-blind Treatment

A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma

Asthma

Enrolled (actual)
301
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Change in FEV1 — -0.40; 0.69; -0.59 percentage of change

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Placebo (Drug); R940343 1mg (Drug); R940343 2mg (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Rigel Pharmaceuticals
Primary completion
Jul 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in FEV1
-0.40; 0.69; -0.59

Summary

The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.

Eligibility Criteria

Inclusion Criteria

  • Clinical history of asthma
  • Ability to perform spirometry

Exclusion Criteria

  • Chronic obstructive pulmonary disease or bronchiectasis
  • Upper or lower respiratory infection
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01591044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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