NCT00561717

Brief Summary

Finding out how fast azelastine nasal spray works in subjects with hay fever.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

May 7, 2013

Status Verified

May 1, 2013

Enrollment Period

2 months

First QC Date

November 20, 2007

Last Update Submit

May 5, 2013

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal Allergic RhinitisRagweedPollenAllergy

Outcome Measures

Primary Outcomes (1)

  • Onset of action measured by change in total nasal symptom score Until "Onset of action" = until drug demonstrates and maintains a change greater than placebo compared to baseline

    Up to 6 hours

Secondary Outcomes (1)

  • Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy

    Effect over 6 hours

Study Arms (4)

Arm 1

EXPERIMENTAL
Drug: Azelastine and placebo

Arm 2

ACTIVE COMPARATOR
Drug: Loratadine and Placebo

Arm 3

ACTIVE COMPARATOR
Drug: Cetirizine and Placebo

Arm 4

PLACEBO COMPARATOR
Drug: Placebo and Placebo (spray and Tablet)

Interventions

Azelastine and placeboDRUG

One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.

Arm 1
Loratadine and PlaceboDRUG

One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.

Arm 2
Cetirizine and PlaceboDRUG

One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.

Arm 3
Placebo and Placebo (spray and Tablet)DRUG

One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.

Arm 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of seasonal allergic rhinitis to ragweed pollen for last 2 consecutive seasons;
  • Positive response to skin prick test to ragweed allergen at screening;
  • Be willing to participate in the trial.

You may not qualify if:

  • History of hypersensitivity to azelastine;
  • Females who are pregnant or lactating;
  • Relative chronic sinusitis or nasal structural abnormalities causing greater than 50% obstruction;
  • Asthma that requires other than occasional use of inhaled short-acting beta-2 antagonist;
  • Known non-responsiveness to antihistamines;
  • Alcoholism or drug abuse within 2 yrs. of screening;
  • Current or regular use within 6 months of any type of tobacco product;
  • Evidence of any clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or malignancies within the last 5 years;
  • History of a positive test to HIV, TB, hepatitis B or C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

  • Tenn MW, Steacy LM, Ng CC, Ellis AK. Onset of action for loratadine tablets for the symptomatic control of seasonal allergic rhinitis in adults challenged with ragweed pollen in the Environmental Exposure Unit: a post hoc analysis of total symptom score. Allergy Asthma Clin Immunol. 2018 Jan 16;14:5. doi: 10.1186/s13223-017-0227-4. eCollection 2018.

    PMID: 29371864DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalHypersensitivity

Interventions

azelastineLoratadineCetirizineTablets

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System Diseases

Intervention Hierarchy (Ancestors)

CyproheptadineDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsHydroxyzinePiperazinesDosage FormsPharmaceutical Preparations

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 21, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Study Completion

February 1, 2008

Last Updated

May 7, 2013

Record last verified: 2013-05

Locations

CA(1)