Allergic Rhinitis MedDRA version: 14.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Cardozin XL (doxazosin)
Product Name: Doxazosin
Pharmaceutical Form: Capsule
INN or Proposed INN: Doxazosin mesilate
CAS Number: 77883-43-3
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Able to provide informed consent Able to comply with the requirements of the protocol Diagnosis of allergic rhinitis Ability to tolerate Doxazosin XL 4mg without clinically significant drop in blood pressure Peak nasal inspiratory flow which is reversible to more than 20 l/min with oxymetazoline Positive skin prick test to at least 1 common aeroallergen Ability to withhold antihistamines for duration of the study Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant’s well being Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Pregnancy, planned pregnancy or lactation Respiratory tract infection in the previous 2 months Nasal polyps of more than Grade 1 on nasal endoscopy Any known adverse reaction to the Investigational Medicinal Product or other quinazolines Known hepatic dysfunction (as no safety data available for this) Systolic blood pressure <100mmHg Any degree of heart block Any clinically significant medical condition that may endanger the health or safety of the participant or jeopardise the protocol Participation within another trial within the last 30 days Under the age of 18 Benign hyperplasia, chronic urinary tract infections, bladder stones, overflow bladder, anuria or progressive renal failure History of oesophageal or gastrointestinal obstruction or decreased lumen diameter of the gastrointestinal tract. Concomitant use of PDE5 inhibitors (sildenafil etc.) Alpha antagonists - this is the medication under investigation Other cardiovascular medications including but not limited to: ACE inhibitors, Angiotensin II antagonists, Beta blockers, calcium channel blockers, diuretics, nitrates, phosphodiesterase type-5 inhibitors or other vasodilating medications – these in combination with doxazosin carry an increased risk of symptomatic hypotension Monoamine oxidase inhibitors (MAOIs) – antidepressant medication that can lead to significant hypotension in combination with alpha antagonists Anxiolytics and hypnotics - enhanced hypotensive and sedative effects when alpha-blockers given in combination with these. Methyldopa and levodopa – potential enhanced hypotensive effect with alpha antagonists Nasal corticosteroid spray – would confound study outcomes Oxymetazoline - this is used as an outcome of response in the study Antihistamines - the participants will be undergoing a histamine nasal challenge Sympathomimetics i.e. dopamine, ephedrine, epinephrine, metaraminol, methoxamine, phenylephrine- may reduce the effect of Doxazosin Any other medication, which in the opinion of the Investigator may put the participant at risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: What are the effects of chronic alpha blocker use on nasal blockage in patients with allergic rhinitis(allergic inflammation of the nose)?;Secondary Objective: Assessing the effects of chronic alpha blocker use in terms of the response to nasal decongestants and nasal hyperreactivity.;Primary end point(s): The primary outcome is the change in peak nasal inspiratory flow from baseline after acute and chronic dosing of doxazosin compared to placebo.;Timepoint(s) of evaluation of this end point: At baseline, 12 hours post acute (first) dosing and 3 to 5 weeks for the chronic dosing for each treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Nasal histamine challenge Nasal airways resistance Nasal nitric oxide Oxymetazoline dose response curve Domiciliary peak nasal inspiratory flow measurements Juniper Rhinoconjunctivitis Quality of Life Questionnaire Total Nasal Symptoms 4 point scale Nasal blockage 10 point visual analogue scale;Timepoint(s) of evaluation of this end point: At baseline, 12 hours post acute (first) dosing and 3 to 5 weeks for the chronic dosing for each treatment period. | — |
Countries
United Kingdom
Contacts
Public ContactArvind Manoharan
Asthma and Allergy Research Group
Outcome results
None listed