Alpha-Blockers in Allergic Rhinitis (MAN 01) (MAN01)

University of Dundee

Status and phase

Completed

Phase 4

Conditions

Allergic Rhinitis

Treatments

Other: Placebo

Drug: Doxazosin XL

Study type

Interventional

Funder types

Other

Identifiers

NCT01946035

2012RC14

Details and patient eligibility

About

Allergic rhinitis (allergic inflammation of the nose) is a common medical condition which is known to seriously decrease quality of life, aggravate preexisting conditions particularly asthma, carry significant medical treatment costs and be responsible for reduced work productivity and lost school days. A significant symptom of the condition, nasal blockage, remains difficult to treat even when using nasal corticosteroids. Decongestant medications act on the blood vessels in the nose and have an immediate effect in clearing a blocked nose but if used for more than seven days a more severe rebound congestion of the nose develops.

In this study, the investigators aim to assess the effects of doxazosin, a drug which is currently used to treat high blood pressure and symptoms of prostate enlargement, to find out if it has an effect on nasal blockage.

Enrollment

17 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female 18-70 years
Able to provide informed consent
Able to comply with the requirements of the protocol
Diagnosis of allergic rhinitis
Peak nasal inspiratory flow which is reversible to >20 l/min with oxymetazoline
Positive skin prick test to at least one common aeroallergen
Ability to withhold antihistamines, intranasal corticosteroids 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

Exclusion criteria

Pregnancy, planned pregnancy or lactation
Respiratory tract infection in the previous 2 months
Nasal polyps of more than Grade I on nasal endoscopy
Any known adverse reaction to the Investigational Medicinal Product or other quinazolines
Systolic BP <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 clinical trial of investigational medicinal product 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.