Allergy Clinical Trial
— MAN06Official title:
Proof of Concept Study to Assess Downstream Effects of Using Combined Intranasal Fluticasone Propionate Plus Azelastine Nasal Spray on Asthmatic Inflammation in Patients With Persistent Asthma and Allergic Rhinitis
Verified date | April 2019 |
Source | University of Dundee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Single centre, double-blind, placebo controlled, adaptive design, cross-over trial. The primary objective is to assess the additive effects of using combined intranasal fluticasone propionate plus azelastine nasal spray on airway hyperresponsiveness. This is in patients with persistent asthma and allergic rhinitis, receiving inhaled steroid.
Status | Terminated |
Enrollment | 7 |
Est. completion date | September 10, 2018 |
Est. primary completion date | September 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female volunteers, aged 18 years and above, with persistent asthma and allergic rhinitis - On a minimum of 200µg BDP of Inhaled corticosteroid (ICS) - FEV1 = 60 % predicted - Positive skin prick test, or record of elevated allergen-specific IgE to at least 1 perennial allergen - Methacholine PC20 < 8mg/ml at Visit 1 - Ability to give informed consent Exclusion Criteria: - Other respiratory diseases such as COPD, bronchiectasis or allergic bronchopulmonary aspergillosis (ABPA) which are considered to be significant in the opinion of the study physician Nasal polyps = Grade 2 - An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement, or 3 months if hospital admission was required - Any clinically significant medical condition that may endanger the health or safety of the participant. For example: Patients who have tuberculosis or any type of untreated infection or have had recent surgical operation or injury to the nose or mouth. - Participation in another trial within 30 days before the commencement of the study - Pregnancy or lactation - Unable to comply with the procedures of the protocol - Unable or unwilling to consent - Taking prohibited medications as listed in section 6.7.2 Prohibited Medications - Hypersensitivity to the active substances or to any of the excipients of Dymista Nasal Spray. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School | Dundee | Scotland |
Lead Sponsor | Collaborator |
---|---|
University of Dundee |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Methacholine PC20 | The provocative concentration of methacholine required to produce a 20% drop (PC20) in forced expiratory volume in 1 second (FEV1) | 3-5 weeks | |
Secondary | Exhaled nitric oxide (FeNO) | A measurement of the amount of inflammation in the airways | 3-5 weeks | |
Secondary | Forced expiratory volume in 1 second (FEV1) | The amount of air exhaled in the first second of a forced expiration. | 3-5 weeks | |
Secondary | Morning peak expiratory flow (PEF) | A measurement of how quickly a patient can blow air out of their lungs | 3-5 weeks | |
Secondary | Airway resistance at 5Hz (R5) | A measurement of the total airway resistance at the frequency of 5 Hertz | 3-5 weeks | |
Secondary | Airway resistance at 20Hz (R20) | A measurement of the proximal airways resistance at the frequency of 20 Hertz | 3-5 weeks | |
Secondary | Peripheral airway resistance (R5-R20) | A measurement of the peripheral airway resistance by taking the resistance at 5Hz and subtracting the resistance at 20 Hertz | 3-5 weeks | |
Secondary | Airway Reactance (X5) | A measurement of the peripheral capacitive reactance at the frequency of 5 Hertz | 3-5 weeks | |
Secondary | Airway Reactance area under the curve (AX) | A measurement of the reactance area between the negative reactance trend and zero. | 3-5 weeks | |
Secondary | Domiciliary peak nasal inspiratory flow (PNIF) | A measurement of how open or blocked the nasal passages are. | 3-5 weeks | |
Secondary | Nasal nitric oxide (NO) | A measurement of the amount of inflammation in the nasal passages. | 3-5 weeks | |
Secondary | Blood eosinophils | A measurement of the amount of eosinophils in the blood | 3-5 weeks | |
Secondary | Eosinophilic cationic protein (ECP) | A measurement of the amount of Eosinophilic Cationic Protein (ECP) in the blood | 3-5 weeks | |
Secondary | Total nasal symptom score (TNS4) | A questionnaire to assess four (4) types of nasal symptoms: runny nose, blocked nose, itchy nose, and sneezing. | 3-5 weeks | |
Secondary | Asthma control questionnaire (ACQ) | A questionnaire to measure the degree of a person's asthma control | 3-5 weeks | |
Secondary | Asthma quality of life questionnaire (AQLQ) | A questionnaire to measure the functional problems that are most troublesome to adults with asthma. | 3-5 weeks | |
Secondary | Rhinitis quality of life questionnaire (RQLQ) | A questionnaire to measure the functional problems that are most troublesome to adults with rhinitis. | 3-5 weeks | |
Secondary | Visual analogue scale (VAS) | a 10 cm line horizontal describing rhinitis symptoms. zero being "not bothersome" and ten being "very bothersome". | 3-5 weeks |
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