AzTrials
AzTrials

Seasonal Allergic RhinitisPhase 3NCT01368445

A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies

A Phase 3 study testing azelastine hydrochloride 0.15% Nasal Spray and Azelastine 0.1%, Nasal Spray in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis. 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 hydrochloride 0.15% Nasal Spray and Azelastine 0.1%, Nasal Spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
617 participants
Where
30 sitesUnited States
Study dates
Aug 2006to Apr 2008
Phase
Phase 3
Are there results?
None posted in the registry

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
  • Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
  • Screening Visit: Have a 12-hour reflective total nasal symptoms score ( TNSS) of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7
  • Randomization Visit: Have a 12-hour reflective total nasal symptoms score (TNSS) (AM or PM) of at least 8 on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM nasal congestion score of 2 or 3 must have been recorded on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1).
  • Must have taken at least 10 doses of study medication during the lead-in period
  • Randomization Visit: An instantaneous (TNSS) of ≥ 8 before beginning the onset of action assessment on Day 1
Show all 11Show fewer
  • Willing and able to comply with the study requirements
  • At least a 2-year history of seasonal allergic rhinitis (SAR) during the fall pollen allergy season
  • The presence of IgE-mediated hypersensitivity to local fall pollen confirmed by a positive response to either skin prick or intradermal testing within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the control for the skin prick test or at least 7 mm larger than the control for the intradermal test.
  • General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer
  • Patients receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation). Patients who are on maintenance doses of sublingual immunotherapy may be considered for the trial on a case-by-case basis after discussion with the sponsor's medical monitor or designee.

Who cannot join

  • The use of any investigational drug within 30 days prior to Day -7. No investigational products are permitted for use during the conduct of this study
  • Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
  • Women who are pregnant or nursing
  • Women of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception
  • Respiratory tract infections within two weeks prior to Day -7
  • Respiratory Infections requiring oral antibiotic treatment two weeks prior to Day -7
Show all 15Show fewer
  • Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities
  • Patients with asthma (with the exception of mild, intermittent asthma)
  • Patients with significant pulmonary disease
  • Patients with a known history of alcohol or drug abuse
  • Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug
  • Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
  • Planned travel outside the study area during the study period
  • Family members and employees should be excluded
  • Patients who received prohibited medications within specified timepoints in the protocol.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Allergy Asthma Associates Research Dept.

    Austin, Texas, 78731

  • Clinical Research Center

    Cincinnati, Ohio, 45231

  • Allergy and Asthma Consultants of NJ-PA, P.C

    Collegeville, Pennsylvania, 19426

  • The William Storms Allergy Clinic

    Colorado Springs, Colorado, 80907

  • AARA Research Center

    Dallas, Texas, 75231

  • Research Across America

    Dallas, Texas, 75234

  • Colorado Allergy and Asthma Centers, PC

    Denver, Colorado, 80230

  • Valley Clinical Research Center

    Easton, Pennsylvania, 18045

  • Oklahoma Institute of Allergy and Asthma

    Edmond, Oklahoma, 73003

  • AABI Associates Medical Group

    Fountain Valley, California, 92708

  • West Coast Clinical Trials

    Long Beach, California, 90806

  • 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

  • Northeast Medical Research Associates, Inc.

    North Dartmouth, Massachusetts, 02747

  • Atlantic Allergy, Asthma & Immunology

    Ocean City, New Jersey, 07712

  • Kansas City Allergy and Asthma

    Overland Park, Kansas, 66210

  • The Asthma and Allergy Center, PC

    Papillion, Nebraska, 68046

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • Allergy and Asthma Institue of Rochester

    Rochester, New York, 14618

  • Allergy Medical Group

    Roseville, California, 95678

  • Sylvana Research Associates

    San Antonio, Texas, 78229

  • Allergy Associates Medical Group

    San Diego, California, 92120

  • Allergy and Asthma Associates of CA

    San Jose, California, 95117

  • Coastal Allergy and Asthma P.C.

    Savannah, Georgia, 31406

  • Princeton Center for Clinical Research

    Skillman, New Jersey, 08558

  • Allergy and Asthma Center

    Waco, Texas, 76712

  • Institute for Asthma and Allergy, P.C.

    Wheaton, Maryland, 20902

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Patients With Seasonal Allergic Rhinitis

The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.

Being tested
azelastine hydrochloride 0.15% Nasal Spray, azelastine hydrochloride 0.15% and Placebo, Azelastine 0.1%, Nasal Spray
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.

  • azelastine hydrochloride 0.15% Nasal SprayDrug

    Also called astepro .15%

    1644 mcg, 2 sprays per nostril twice daily AM \& PM)

  • azelastine hydrochloride 0.15% and PlaceboDrug

    Also called Astepro.15%

    822 mcg azelastine hydrochloride 0.15%, 2 sprays per nostril once daily (AM) and 0mg placebo spray 2 sprays per nostril once daily (PM)

  • Azelastine 0.1%, Nasal SprayDrug

    Also called Astepro

    1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM \& PM)

Study groups in NCT01368445
Study groupRoleWhat they receive
MP03-36 Nasal SprayActive comparatorazelastine hydrochloride 0.15%
Receives: Drug: azelastine hydrochloride 0.15% Nasal Spray
MP03-36 and Placebo Nasal SprayActive comparatorazelastine hydrochloride 0.15% and Placebo
Receives: Drug: azelastine hydrochloride 0.15% and Placebo
Azelastine 0.1%, Nasal SprayActive comparatorAzelastine 0.1%, Nasal Spray
Receives: Drug: Azelastine 0.1%, Nasal Spray
Placebo Nasal SaprayPlacebo comparator0mg, 2 sprays per nostril twice daily AM \& PM)
Receives: Drug: azelastine hydrochloride 0.15% Nasal Spray; Drug: azelastine hydrochloride 0.15% and Placebo; Drug: Azelastine 0.1%, Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo

    Measured: 14 Days

Secondary outcomes (3)

  1. Change from baseline in instantaneous total nasal symptoms score (TNSS) for the entire 14-day study period compared to placebo

    Measured: 14 Days

  2. Change from baseline to Day 14 in Roland Quality of Life Questionnaire (RQLQ )compared to placebo

    Measured: 14 Days

  3. Change From Baseline on Direct Visual Nasal Exams

    Measured: 14 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2011 (estimated)
  2. Study startAug 2006
  3. Primary completionNov 2006
  4. Study completionApr 2008

Resources

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
Factorial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
617 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01368445
Sponsor's protocol ID
MP433
Status last verified
Oct 2011
First submitted
6 Jun 2011
Last updated
6 Oct 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing azelastine hydrochloride 0.15% Nasal Spray and Azelastine 0.1%, Nasal Spray in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 30 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 11 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 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 symptoms score(TNSS) for the entire 14-day study period compared to placebo (time frame: 14 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01368445.

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 6 Oct 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in