Phase
Condition
Common Cold
Acute Rhinitis
Allergies & Asthma
Treatment
N/AClinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
General Inclusion Criteria: To be eligible for enrolment into this study, a patient must comply with all of thefollowing criteria:
- Male or female patient 12 years of age or older.
- Provide written informed consent.
- Patients must have moderate-to-severe rhinitis or rhinoconjunctivitis, defined asrhinitis/rhinoconjunctivitis with one or more of the following being present:
- Sleep disturbance.
- Impairment of daily activities, leisure and/or sport.
- Impairment of learning or work.
- Troublesome symptoms.
- Patients must have moderate-to-severe rhinitis or rhinoconjunctivitis and monotherapywith either intranasal antihistamine or glucocorticoid is not considered sufficient atthe discretion of the Investigator and/or designee.
- Conducting the Lead-in Period according to the protocol.
- Willing and able to comply with the study requirements.
- At least a 2-year history of AR (seasonal and/or perennial) during the same time ofyear as the scheduled study time.
- The presence of Immunoglobulin E (IgE)-mediated hypersensitivity to one or moreaeroallergens present in current patient environment, confirmed by a positive responseto an established standard diagnostic test at the site within the last year (beforerandomization).
- General good health and free of any disease or concomitant treatment that couldinterfere with the interpretation of the study results as determined by theInvestigator or the sponsor's medical officer. When in doubt, the Investigator shouldconfer with the sponsor's medical monitor or designee to determine eligibility for thestudy.
- Patient agrees to avoid prohibited medication and alcohol and use effective methods ofcontraception during the study.
- Negative pregnancy test in women with childbearing potential.
Exclusion
General Exclusion Criteria: A patient is ineligible and must not enter the study if any of the following criteria ismet: Safety concerns:
- Presence of any hypersensitivity to drugs similar to azelastine hydrochloride,fluticasone propionate, or to any of the excipients.
- Women who are pregnant or nursing.
- Women of childbearing potential who are not abstinent or not practicing a medicallyacceptable method of contraception.
- Clinically significant arrhythmia (or unstable despite medical treatment) orsymptomatic cardiac conditions.
- A known history of alcohol or drug abuse within the last 2 years.
- Diagnosis of human immunodeficiency virus (HIV) infection.
- Patients with a diagnosis of Glaucoma, cataract, or central serous chorioretinopathy (CSCR). Lack of suitability for the study:
- Nasal disease(s) likely to affect deposition of intranasal medication, such assinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasalstructural abnormalities (e.g. nasal septum deviation).
- Nasal surgery or sinus surgery within the previous year.
- Chronic sinusitis - more than 3 episodes per year.
- Major malignancies including pheochromocytoma within the last 5 years. Exception willbe considered where malignancies have been resolved as judged by Investigator.
- The use of any investigational drug within 30 days prior to Screening Visit. No otherinvestigational products are permitted for use during the conduct of this study.
- Respiratory Tract Infections including within 14 days prior to Screening Visit.
- Asthma (with the exception of mild intermittent asthma). Patients with mildintermittent asthma who only require short-acting inhaled bronchodilators and who donot have nocturnal awakening as a result of asthma are eligible for enrolment.
- Other significant diseases of bronchus and lungs including chronic obstructivepulmonary disease (COPD), emphysema, bronchiectasis, tuberculosis, pneumonia.
- Any surgical or medical condition or physical or laboratory findings, which in theopinion of the Investigator or sponsor's medical monitor, might significantly alterthe absorption, distribution, metabolism, or excretion of study drug; that mightsignificantly affect the patient's ability to complete this trial; or their safety inthis trial.
- Clinically relevant abnormal physical findings during the Lead-in Period which, in theopinion of the Investigator, would interfere with the objectives of the study or thatmay preclude compliance with the study procedures.
- Current use or expected requirement of ritonavir or strong P4503A4 inhibitorsincluding cobicistat-containing products.
- Specific immunotherapy within 6 months prior to Screening Visit. If the patientreceived immunotherapy a 6-month washout period is required following the last dose ofimmunotherapy.
- Use of certain medications or therapies (e.g. for Allergic Rhinitis) within aspecified time period Administrative reasons:
- Planned travel outside of the aeroallergen area during the study period.
- Employees of the Sponsor, research centre or private practice and their familymembers.
- Start-of-treatment Visit (Day 1): have not fully completed Diary.
Study Design
Study Description
Connect with a study center
Investigational Site 2
Beijing, Beijing
ChinaSite Not Available
Investigational Site 3
Beijing, Beijing
ChinaSite Not Available
Investigational Site 4
Beijing, Beijing
ChinaSite Not Available
Investigational Site 5
Beijing, Beijing
ChinaSite Not Available
Investigational Site
Chongqing, Chonqing
ChinaSite Not Available
Investigational Site 1
Beijing, Dongcheng District
ChinaSite Not Available
Investigational Site 1
Guangzhou, Guangdong
ChinaSite Not Available
Investigational Site 2
Guangzhou, Guangdong
ChinaSite Not Available
Investigational Site 1
Wuhan, Hubei
ChinaSite Not Available
Investigational Site 2
Wuhan, Hubei
ChinaSite Not Available
Investigational Site
Changsha, Hunan
ChinaSite Not Available
Investigational Site
Nanchang, Jiangxi
ChinaSite Not Available
Investigational Site
Chang chun, Jilin
ChinaSite Not Available
Investigational Site
Tonghua, Jilin
ChinaSite Not Available
Investigational Site
Yanbian, Jilin
ChinaSite Not Available
Investigational Site
Jining, Jining
ChinaSite Not Available
Investigational Site
Dalian, Liaoning
ChinaSite Not Available
Investigational Site
Nanjing, Nanjing
ChinaSite Not Available
Investigational Site 1
Qingdao, Shandong
ChinaSite Not Available
Investigational Site 2
Qingdao, Shandong
ChinaSite Not Available
Investigational Site
Yantai, Shangdong
ChinaSite Not Available
Investigational Site
Zibo, Shangdong
ChinaSite Not Available
Investigational Site
Shanghai, Shanghai
ChinaSite Not Available
Investigational Site
Changzhi, Shanxi
ChinaSite Not Available
Investigational Site
Taiyuan, Shanxi
ChinaSite Not Available
Investigational Site 1
Xi'an, Shanxi
ChinaSite Not Available
Investigational Site 2
Xi'an, Shanxi
ChinaSite Not Available
Investigational Site
Chengdu, Sichuan
ChinaSite Not Available
Investigational Site 1
Tianjin, Tianjin
ChinaSite Not Available
Investigational Site 2
Tianjin, Tianjin
ChinaSite Not Available
Investigational Site 3
Tianjin, Tianjin
ChinaSite Not Available
Investigational Site 4
Tianjin, Tianjin
ChinaSite Not Available
Investigational Site
Ürümqi, Xianjiang Uygur
ChinaSite Not Available
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