Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis (SAR)

This study has been completed.
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT01241214
First received: November 12, 2010
Last updated: January 6, 2012
Last verified: January 2012
  Purpose

This study will assess the efficacy and safety of different doses of ACT-129968 in adult patients with seasonal allergic rhinitis, due to mountain cedar pollen.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: ACT-129968
Drug: Reference
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group, Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo [ Time Frame: Baseline to week 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To demonstrate a change in Daytime Nasal Symptom Score while taking either Dose 1, Dose 2, or Dose 4 of ACT-129968 verses placebo. [ Time Frame: Baseline to week 2 ] [ Designated as safety issue: No ]

Enrollment: 579
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational drug - Dose 1 Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Experimental: Investigational drug - Dose 2 Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Experimental: Investigational drug - Dose 3 Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Experimental: Investigational Drug - Dose 4 Drug: ACT-129968
ACT-129968 (Dose 4) & matching placebo administered orally once daily
Active Matching Reference Drug: Reference
Active matching reference administered once daily & matching placebo administered twice daily.
Placebo Comparator: Matching Placebo Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Drug: ACT-129968
ACT-129968 (Dose 4) & matching placebo administered orally once daily
Drug: Reference
Active matching reference administered once daily & matching placebo administered twice daily.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females aged 18 to 70 years.
  • Clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last two years.
  • Adequate exposure to mountain cedar pollen.
  • Positive skin prick test to mountain cedar allergen within 12 months of screening.
  • Sufficient nasal symptom score during a run-in period.

Exclusion Criteria:

  • Non-allergic rhinitis.
  • Bacterial or viral respiratory tract infection.
  • Chronic respiratory disorders.
  • Asthma requiring treatment other than inhaled short-acting Beta2-agonists.
  • Ocular infections or surgery, nasal obstruction, nasal biopsy or surgery, sinus surgery or perforation.
  • Smoking within the last year.
  • Ongoing or recent treatment for seasonal allergic rhinitis.
  • Initiation of allergen immunotherapy within 6 months of screening.
  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: NCT01241214

Locations
United States, Texas
Clinical Investigative Site 7905
Austin, Texas, United States, 78731
Clinical Investigative Site 7907
Kerrville, Texas, United States, 78028
Clinical Investigative Site 7903
New Braunfels, Texas, United States, 78130
Clinical Investigative Site 7904
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7901
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7906
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7902
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Actelion
Investigators
Study Director: Sara Mangialaio, MD Actelion
  More Information

No publications provided

Responsible Party: Sponsor, Actelion
ClinicalTrials.gov Identifier: NCT01241214     History of Changes
Other Study ID Numbers: AC-060B202
Study First Received: November 12, 2010
Last Updated: January 6, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Actelion:
Seasonal allergic rhinitis
SAR
Allergic rhinitis
Allergies

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 21, 2014