Seasonal Allergic RhinitisPhase 3NCT00651118
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
A Phase 3 study testing azelastine Hcl, azelastineHcl / fluticasone propionate and fluticasone propionate in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 43 sites in United States.
Trial summary
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone) Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- azelastine Hcl, azelastineHcl / fluticasone propionate and fluticasone propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 832 participants
- Where
- 43 sitesUnited States
- Study dates
- Mar 2008to Jul 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
- Must be in generally good health
- Must meet minimum symptom requirements, as specified in the protocol
- Must be wiling and able to provide informed consent and to participate all study procedures
- Positive skin test to a prevalent spring allergen
Who cannot join
- On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
- Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum
- Nasal or sinus surgery within the previous 6 months
- Chronic sinus infection (more than 3 per year)
- Planned travel outside the study area during the study period
- Use of any investigational drug within 30 days of the first visit
Show all 15Show fewer
- Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)
- Women who are not using an acceptable method or birth control
- Women who are pregnant or nursing
- Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit
- Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator
- Irregular heartbeat or other symptomatic heart conditions
- History of alcohol or drug abuse
- History of glaucoma
- Use of medications that could affect the study results
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Clinical Research Atlanta
Atlanta, Georgia, 30342
Allergy and Asthma Associates
Austin, Texas, 78731
Allergy and Asthma Center of Austin
Austin, Texas, 78759
National Allergy, Asthma and Urticaria of Charleston
Charleston, South Carolina, 29407
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
Allergy and Consultants of NJ/PA
Collegeville, Pennsylvania, 19426
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907
AARA Research Center
Dallas, Texas, 75231
Jane Lee, MD, PA Research Center
Dallas, Texas, 75246
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230
Intermountain Clinical Research
Draper, Utah, 84020
Clinical Research Center
Encinitas, California, 92024
East Tennesse Center for Clinical Research
Knoxville, Tennessee, 37909
Allergy Asthma and Dermatology Research
Lake Oswego, Oregon, 97035
Colorado Allergy and Asthma Centers
Lakewood, Colorado, 80401
Allergy, Asthma and Immunology Associates
Lincoln, Nebraska, 68505
Allergy Research Foundation
Los Angeles, California, 90025
Clinical Research Institute
Minneapolis, Minnesota, 55402
Southern California Research
Mission Viejo, California, 92691
Central Texas Health Research
New Braunfels, Texas, 78130
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747
Atlantic Research Center
Ocean City, New Jersey, 07712
Kansas City Allergy and Asthma
Overland Park, Kansas, 66210
The Asthma and Allergy Center
Papillion, Nebraska, 68046
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Clinical Research Institute
Plymouth, Minnesota, 55441
North Carolina Clinical Research
Raleigh, North Carolina, 27607
AAIR Research Center
Rochester, New York, 14618
Island Medical Research
Rockville Centre, New York, 11570
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Sylvana Research Associates
San Antonio, Texas, 78229
Allergy and Asthma Medical Group and Research Center
San Diego, California, 92123
Aeroallergy Research Laboratories of Savannah
Savannah, Georgia, 31406
Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, 85251
Asthma, Inc.
Seattle, Washington, 98105
The Clinical Research Center
St Louis, Missouri, 63141
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Bensch Research Associates
Stockton, California, 95207
Allergy Clinic of Tulsa
Tulsa, Oklahoma, 74133
Asthma and Allergy Research Associate
Upland, Pennsylvania, 19013
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598
Research Asthma, Sinus and Allergy Centers
Warren Township, New Jersey, 07059
About this study
Official title: Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
Read the detailed description
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.
Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; and the symptom of postnasal drip, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Placebo, azelastine Hcl, azelastineHcl / fluticasone propionate, fluticasone propionate
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo
azelastine HclDrug
Also called azelastine
azelastine Hcl 548 mcg
azelastineHcl / fluticasone propionateDrug
Also called MP29-02
azelastine Hcl 548 mcg / fluticasone propionate 200 mcg
fluticasone propionateDrug
Also called fluticasone
fluticasone propionate 200 mcg
| Study group | Role | What they receive |
|---|---|---|
| fluticasone propionate | Active comparator | Not described Receives: Drug: fluticasone propionate |
| azelastineHcl/fluticasone propionate | Experimental | Not described Receives: Drug: azelastineHcl / fluticasone propionate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| azelastine Hcl | Active comparator | Not described Receives: Drug: azelastine Hcl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)
change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.
The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result.
Measured: days 1 to 14
Secondary outcomes (2)
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.
The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result.
Measured: day 1 to day 14
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days
adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.
The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result.
Measured: day 1 to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 832 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lewis M. Fredane, MD, Study director, Meda Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651118
- Sponsor's protocol ID
- MP4002
- Status last verified
- Aug 2012
- First submitted
- 28 Mar 2008
- Last updated
- 26 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00651118
- Acronym / sponsor ID
- MP4002
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 832 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Posted 26 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
Detailed description
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.
Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; and the symptom of postnasal drip, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fluticasone propionate | Active comparator | Drug: fluticasone propionate |
| azelastineHcl/fluticasone propionate | Experimental | Drug: azelastineHcl / fluticasone propionate |
| Placebo | Placebo comparator | Drug: Placebo |
| azelastine Hcl | Active comparator | Drug: azelastine Hcl |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
- Must be in generally good health
- Must meet minimum symptom requirements, as specified in the protocol
- Must be wiling and able to provide informed consent and to participate all study procedures
- Positive skin test to a prevalent spring allergen
Key exclusion criteria (15 listed)
- On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
- Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum
- Nasal or sinus surgery within the previous 6 months
- Chronic sinus infection (more than 3 per year)
- Planned travel outside the study area during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboplacebo | Drug | Placebo |
| azelastine HclAlso: azelastineazelastine Hcl 548 mcg | Drug | azelastine Hcl |
| azelastineHcl / fluticasone propionateAlso: MP29-02azelastine Hcl 548 mcg / fluticasone propionate 200 mcg | Drug | azelastineHcl/fluticasone propionate |
| fluticasone propionateAlso: fluticasonefluticasone propionate 200 mcg | Drug | fluticasone propionate |
Primary outcome
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)
Time frame: days 1 to 14
change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result.
2 secondary outcomes
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
Time frame: day 1 to day 14
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days
Time frame: day 1 to day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis M. Fredane, MD study director
Meda Pharmaceuticals
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing azelastine Hcl, azelastineHcl / fluticasone propionate and fluticasone propionate in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS) (time frame: days 1 to 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2012.