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Rhinitis, Allergic, PerennialPhase 4NCT00806754

Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy (BY9010/M1-490)

A Phase 4 study testing Ciclesonide nasal spray + Azelastine in people with Rhinitis, Allergic, Perennial, run by AstraZeneca at 35 sites in United States.

Completed

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

Official record
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Trial summary

The primary objective of this study is to evaluate the efficacy of the concomitant administration of ciclesonide nasal spray and azelastine nasal spray versus ciclesonide nasal spray alone in patients (18 years or older) with perennial allergic rhinitis (PAR) not adequately controlled on an intranasal corticosteroid… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rhinitis, Allergic, Perennial
What is being tested?
Ciclesonide nasal spray + Azelastine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
340 participants
Where
35 sitesUnited States
Study dates
Nov 2006to Aug 2007
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 18 years of age or older at the B0 Visit.
  • General good health, and free of any concomitant conditions or treatment that in the investigator's judgment could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial.
  • A history of PAR for a minimum of two years immediately preceding the Screening Visit (B0). The PAR must have been of sufficient severity to require treatment(continuous or intermittent) in the past with intranasal corticosteroids and/or antihistamines and, in the investigator's judgment, experienced less than complete symptom alleviation on this prior therapy. In addition, the patient is again expected to require treatment throughout the study period.
  • A demonstrated sensitivity to at least one allergen known to induce PAR through a standard prick test within one year of study start. A positive test is defined as a wheal diameter at least 3 mm larger than the control (saline) wheal for the prick test. Documentation of a positive result within 12 months prior to the Screening Visit (B0) is acceptable.
  • Females of childbearing potential currently using contraception must continue to use a medically reliable method of contraception for the entire study duration(e.g. oral, injectable, trans-cutaneous or implantable contraceptives or intrauterine devices or double-barrier protection).Females who are not sexually active must agree to use double-barrier protection should they become active during the course of the study. Women of childbearing potential, or less than 1 year postmenopausal, will require a negative plasma pregnancy test at the Screening Visit (B0). Females will be considered to be of non-child-bearing potential and will not require a urine pregnancy test if at least one of the following apply:
  • More than one year post-menopausal
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  • Had a hysterectomy
  • Had bilateral ovariectomy or salpingectomy or tubal ligation
  • Has congenital sterility
  • Patients on intranasal corticosteroids and antihistamines should be on a stable dose for at least 4 weeks.
  • Patients must complete a 24-hour reflective total nasal symptom assessment at the Screening Visit (B0) and score a total of 6 or greater (out of 12).

Who cannot join

  • Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period.
  • History of physical findings of nasal pathology, including nasal polyps (within the last 60 days) or other clinically significant respiratory tract malformations, recent nasal biopsy (within the last 60 days), nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days).
  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit.
  • A known hypersensitivity to any intranasal corticosteroid, antihistamine or any of the excipients in the formulation.
  • History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, the common cold, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit, or development of a respiratory infection during the Screening Period.
  • History of alcohol or drug abuse within the preceding two years.
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  • History of a positive test for HIV, hepatitis B or hepatitis C.
  • Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of b-agonists; intermittent use of b-agonists is acceptable.
  • Use of any prohibited concomitant medications within the prescribed (per protocol) time since last dose period prior to the Screening Visit (B0) and during entire treatment duration.
  • Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit (B0). Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit AND is expected to continue throughout the trial.
  • Initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the Screening Visit AND use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.
  • Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0).
  • Exposure to systemic corticosteroids for any indication, chronic or intermittent (e.g.: contact dermatitis), during the past 2 months, or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.
  • Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone for dermatological conditions during the past 1 month, or presence of an underlying condition that can reasonably be expected to require treatment with such preparations during the course of the study.
  • History of epilepsy or seizures (excluding febrile seizures).
  • History of coronary artery disease, uncontrolled hypertension, or other clinically significant cardiovascular disease.
  • Patients using combination treatment for allergic rhinitis (e.g. intranasal corticosteroid and antihistamine).
  • Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult:
  • Impaired hepatic function including alcohol-related liver disease or cirrhosis;
  • History of ocular disturbances e.g. glaucoma or posterior subcapsular cataracts;
  • Any systemic infection;
  • Hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism);· Gastrointestinal disease;
  • Malignancy (excluding basal cell carcinoma).
  • Clinical site employees and their immediate relatives are excluded from study participation.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Altana/Nycomed

    Ashland, Oregon, 97520

  • Altana/Nycomed

    Bethesda, Maryland, 20814

  • Altana/Nycomed

    Charleston, South Carolina, 29414

  • Altana/Nycomed

    Cincinnati, Ohio, 45231

  • Altana/Nycomed

    Colorado Springs, Colorado, 80907

  • Altana/Nycomed

    Dallas, Texas, 75231

  • Altana/Nycomed

    Denver, Colorado, 80206

  • Altana/Nycomed

    Encinitas, California, 92024

  • Altana/Nycomed

    Gainesville, Georgia, 30501

  • Altana/Nycomed

    Lakewood, Colorado, 80401

  • Altana/Nycomed

    Los Angeles, California, 90025

  • Altana/Nycomed

    Medford, Oregon, 97504

  • Altana/Nycomed

    Metairie, Louisiana, 70006

  • Altana/Nycomed

    Milwaukee, Wisconsin, 53209

  • Altana/Nycomed

    Mission Viejo, California, 92691

  • Altana/Nycomed

    Newport News, Virginia, 23606

  • Altana/Nycomed

    North Dartmouth, Massachusetts, 02747

  • Altana/Nycomed

    Novi, Michigan, 48375

  • Altana/Nycomed

    Overland Park, Kansas, 66210

  • Altana/Nycomed

    Papillion, Nebraska, 68046

  • Altana/Nycomed

    Pittsburgh, Pennsylvania, 15241

  • Altana/Nycomed

    Portland, Oregon, 97213

  • Altana/Nycomed

    Raleigh, North Carolina, 27612

  • Altana/Nycomed

    Richmond, Virginia, 23226

  • Altana/Nycomed

    Rolla, Missouri, 65401

  • Altana/Nycomed

    San Antonio, Texas, 78229

  • Altana/Nycomed

    San Diego, California, 92123

  • Altana/Nycomed

    San Jose, California, 95117

  • Altana/Nycomed

    Savannah, Georgia, 31406

  • Altana/Nycomed

    Shreveport, Louisiana, 71105

  • Altana/Nycomed

    Skillman, New Jersey, 08558

  • Altana/Nycomed

    South Burlington, Vermont, 05403

  • Altana/Nycomed

    Stockbridge, Georgia, 30281

  • Altana/Nycomed

    Sylvania, Ohio, 43560

  • Altana/Nycomed

    Upland, Pennsylvania, 19013

Other trials in United States

About this study

Official title: Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy

  • The primary objective of this study is to evaluate the efficacy of the concomitant administration of ciclesonide nasal spray and azelastine nasal spray versus ciclesonide nasal spray alone in patients (18 years or older) with perennial allergic rhinitis (PAR) not adequately controlled on an intranasal corticosteroid or antihistamine monotherapy
  • The secondary objective is to investigate the safety of the concomitant administration of ciclesonide nasal spray and azelastine nasal spray
Being tested
Ciclesonide nasal spray + placebo Azelastine, Ciclesonide nasal spray + Azelastine
Keywords
Perennial Allergic Rhinitis, Ciclesonide, PAR
Medical subject headings
Rhinitis, Allergic, Perennial

What participants receive

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

  • Ciclesonide nasal spray + placebo AzelastineDrug

    Ciclesonide nasal spray 50 mcg + Placebo Azelastine

  • Ciclesonide nasal spray + AzelastineDrug

    Ciclesonide nasal spray 50 mcg + Azelastine 137 mcg

Study groups in NCT00806754
Study groupRoleWhat they receive
1Active comparatorCiclesonide nasal spray (50 mcg/spray, one spray per nostril) and placebo azelastine nasal spray ( two sprays per nostril) administered twice daily approximately 1 minute apart, once in the morning and 12 hours later, in the evening.
Receives: Drug: Ciclesonide nasal spray + placebo Azelastine
2Active comparatorCiclesonide nasal spray (50 mcg/spray, one spray per nostril) and azelastine nasal spray (137 mcg/spray, two sprays per nostril) administered twice daily approximately 1 minute apart, once in the morning and 12 hours later, in the evening.
Receives: Drug: Ciclesonide nasal spray + Azelastine

What is being measured

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

  1. Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the four weeks of treatment

    Measured: 4 weeks

Secondary outcomes (1)

  1. Total physician-assessed nasal symptoms score (PNSS) at Endpoint

    Measured: 28 days

Timeline

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

  1. First posted11 Dec 2008 (estimated)
  2. Study startNov 2006
  3. Primary completionMay 2007
  4. Study completionAug 2007

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00806754
Sponsor's protocol ID
BY9010/M1-490
Status last verified
Nov 2016
First submitted
10 Dec 2008
Last updated
23 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ciclesonide nasal spray + Azelastine in people with Rhinitis, Allergic, Perennial, run by AstraZeneca at 35 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 24 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the four weeks of treatment (time frame: 4 weeks). 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 NCT00806754.

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 23 Nov 2016.

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