Alpha-Blockers in Allergic Rhinitis (MAN 01)

NCT01946035 | Completed Phase 4

• 1 other identifier: 2012RC14
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in peak nasal inspiratory from baseline as compared with acute and chronic dosing of doxazosin versus placebo

  12 hours; 3 to 5 weeks

Secondary Outcomes (5)

• Nasal histamine challenge response as measured by peak nasal inspiratory flow after chronic dosing

  12 hours; 3 to 5 weeks

• Nasal airways resistance after single and chronic dosing

  12 hours; 3 to 5 weeks

• Domiciliary peak nasal inspiratory measurements after chronic dosing

  12 hours; 3 to 5 weeks

• Symptoms after chronic dosing

  12 hours; 3 to 5 weeks

• Mini Rhinoconjunctivitis Quality of Life Questionnaire after chronic dosing

  24 hours; 3 to 5 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will take 1 capsule placebo each evening

Other: Placebo

Doxazosin XL

EXPERIMENTAL

Participants will take 1 capsule Doxazosin 4mg XL each evening

Drug: Doxazosin XL

Interventions

Doxazosin XL DRUG

Also known as: Cardozin XL 4mg Prolonged-release Tablets

Doxazosin XL

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Brian Lipworth

Dundee, DD1 3AU, United Kingdom

Location

Related Publications (1)

• Manoharan A, Morrison AE, Lipworth BJ. Effects of the inverse alpha-agonist doxazosin in allergic rhinitis. Clin Exp Allergy. 2016 May;46(5):696-704. doi: 10.1111/cea.12700.

  PMID: 26741127 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Brian J Lipworth, MD

  University of Dundee

  PRINCIPAL INVESTIGATOR

• Arvind Manoharan, MBChB

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Allergy and Pulmonology

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 19, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

GB (1)