Chronic Allergic RhinitisPhase 3NCT00783432

Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis

A Phase 3 study testing Astepro Nasal Spray (0.1% azelastine hydrochloride) and Astelin Nasal Spray (0.1% azelastine hydrochloride) in people with Chronic Allergic Rhinitis and Nonallergic Rhinitis, run by Meda Pharmaceuticals at 1 site 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 determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride) Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Chronic Allergic Rhinitis, Nonallergic Rhinitis
What is being tested?: Astepro Nasal Spray (0.1% azelastine hydrochloride) and Astelin Nasal Spray (0.1% azelastine hydrochloride)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 862 participants
Where: 1 siteUnited States
Study dates: Jul 2006to Dec 2007
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 an established history (> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR).
Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
Willing and able to comply with the study requirements, including daily use of medication for a one year period, even if symptoms are not bothersome.
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 (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)

Who cannot join

The use of any investigational drug within 30 days prior to screening. No other 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. Female patients must practice an acceptable contraceptive technique for 30 days before randomization and agree to continue its use during treatment and for 30 days after the last dose of study drug. Oral, intrauterine, implantable, injectable contraceptives, or a double barrier form of contraception are acceptable and the medication including dose, device or method must have been stable for at least 30 days before the first dose of study drug.
Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities
Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease

Show all 10Show fewer

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 evaluation of study
Clinically relevant abnormal history and/or physical findings which, in the opinion of the investigator or sponsor, would interfere with the objectives of the study or that may preclude compliance with the study procedures
Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

Meda Clinical Trials Contact Center
Somerset, New Jersey, 08873

Other trials in United States

About this study

Official title: Active-Controlled Trial of the Safety and Tolerability of a MP03-33 in Patients With Chronic Allergic or Nonallergic Rhinitis

The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)

Conditions: Chronic Allergic Rhinitis, Nonallergic Rhinitis
Being tested: Astepro Nasal Spray (0.1% azelastine hydrochloride), Astelin Nasal Spray (0.1% azelastine hydrochloride)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Astepro Nasal Spray (0.1% azelastine hydrochloride)Drug
548 mcg (2 sprays per nostril) twice a day
Astelin Nasal Spray (0.1% azelastine hydrochloride)Drug
548 mcg (2 sprays per nostril) twice a day

Study groups in NCT00783432
Study group	Role	What they receive
1	Experimental	Astepro Nasal Spray (0.1% azelastine hydrochloride) Receives: Drug: Astepro Nasal Spray (0.1% azelastine hydrochloride)
2	Active comparator	Astelin Nasal Spray (0.1% azelastine hydrochloride) Receives: Drug: Astelin Nasal Spray (0.1% azelastine hydrochloride)

What is being measured

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

Number of Participants Reporting Adverse Events
An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.
Measured: 12 months
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.
Measured: baseline and 12 months/ET

Secondary outcomes (1)

Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.
The RQLQ consists of 7 domains rated on a 7-point scale with 0 being not troubled by the allergy symptoms,and 6 being extremely troubled. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.
Measured: baseline, months 1,3,6,9 and 12/or early termination

Timeline

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

Jul 2006Dec 2007

First posted31 Oct 2008 (estimated)
Study startJul 2006
Primary completionDec 2007
Study completionDec 2007

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 Chronic 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: None (open label)
Enrolment: 862 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00783432
Sponsor's protocol ID: MP432
Status last verified: Oct 2009
First submitted: 30 Oct 2008
Last updated: 6 Oct 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Enrolling by invitation
A Randomized Controlled Trial Comparing Posterior Nasal Nerve Ablation Procedures for Chronic Rhinitis
Chronic Rhinitis, Non-allergic Rhinitis
Recruiting
Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid
Allergic Rhinitis
Recruiting
EmoTIChealth: Promoting Adolescent Health Through a Serious Game.
Type 1 Diabetes, Asthma

All Chronic Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Active-Controlled Trial of the Safety and Tolerability of a MP03-33 in Patients With Chronic Allergic or Nonallergic Rhinitis
ClinicalTrials.gov ID: NCT00783432
Acronym / sponsor ID: MP432
Conditions: Chronic Allergic Rhinitis, Nonallergic Rhinitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 862 participants (actual)
Lead sponsor: Meda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jul 2006
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 31 Oct 2008 (estimated)
Results: Posted 2 Oct 2009

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 Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Astepro Nasal Spray (0.1% azelastine hydrochloride)Astepro Nasal Spray (0.1% azelastine hydrochloride)
2	Active comparator	Drug: Astelin Nasal Spray (0.1% azelastine hydrochloride)Astelin Nasal Spray (0.1% azelastine hydrochloride)

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 an established history (> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR).
Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
Willing and able to comply with the study requirements, including daily use of medication for a one year period, even if symptoms are not bothersome.
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 (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)

Key exclusion criteria (10 listed)

The use of any investigational drug within 30 days prior to screening. No other 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. Female patients must practice an acceptable contraceptive technique for 30 days before randomization and agree to continue its use during treatment and for 30 days after the last dose of study drug. Oral, intrauterine, implantable, injectable contraceptives, or a double barrier form of contraception are acceptable and the medication including dose, device or method must have been stable for at least 30 days before the first dose of study drug.
Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities

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
Astepro Nasal Spray (0.1% azelastine hydrochloride)548 mcg (2 sprays per nostril) twice a day	Drug	1
Astelin Nasal Spray (0.1% azelastine hydrochloride)548 mcg (2 sprays per nostril) twice a day	Drug	2

Primary outcome

Number of Participants Reporting Adverse Events
Time frame: 12 months
An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Time frame: baseline and 12 months/ET
Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.

1 secondary outcome

Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.
Time frame: baseline, months 1,3,6,9 and 12/or early termination

Results and safety

Results posted to the registry on 2 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Astepro Nasal Spray	430	345
Astelin Nasal Spray	432	354

Primary outcome: Number of Participants Reporting Adverse Events

Time frame: 12 months. Number. Unit: Participants

Measure	Astepro Nasal Spray n = 428	Astelin Nasal Spray n = 430
Value	207	211

Population analysed: Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication.

Primary outcome: Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.

Time frame: baseline and 12 months/ET. Number. Unit: Participants

Measure	Astepro Nasal Spray n = 428	Astelin Nasal Spray n = 430
Conjunctiva: Total baseline	428	430
Conjunctiva: baseline-None	264	254
Conjunctiva: baseline-Mild (1+)	99	109
Conjunctiva: baseline-Moderate (2+)	53	54
Conjunctiva: baseline-Severe (3+)	12	13
Conjunctiva: Total M12/ET	414	417
Conjunctiva: M12/ET-None	366	363
Conjunctiva: M12/ET-Mild (1+)	44	43

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Astepro Nasal Spray	7 of ?	163 of ?	Not reported
Astelin Nasal Spray	10 of ?	146 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Allergic Rhinitis

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Enrolling by invitation
A Randomized Controlled Trial Comparing Posterior Nasal Nerve Ablation Procedures for Chronic Rhinitis
Chronic Rhinitis, Non-allergic Rhinitis
Recruiting
Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid
Allergic Rhinitis
Recruiting
EmoTIChealth: Promoting Adolescent Health Through a Serious Game.
Type 1 Diabetes, Asthma

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 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 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 2 Oct 2009). 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?

Number of Participants Reporting Adverse Events (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT00783432.

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 2009.