Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis - Full Text View

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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:

MedlinePlus related topics: Hay Fever

U.S. FDA Resources

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 ]

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 ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
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 7901
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7902
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7904
San Antonio, Texas, United States, 78229
Clinical Investigative Site 7906
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Actelion

Investigators


Study Director:	Sara Mangialaio, MD	Actelion

More Information


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

Keywords provided by Actelion:


Seasonal allergic rhinitis SAR Allergic rhinitis Allergies

Additional relevant MeSH terms:


Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections	Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2017

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