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

April 10, 2019 updated by: Brian J Lipworth, University of Dundee

A Proof of Concept Study in Allergic Rhinitis, to Evaluate the Differential Effects Between Single and Chronic Dosing of Doxazosin on Nasal Airway Calibre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will take 1 capsule placebo each evening
Other: Placebo
Experimental: Doxazosin XL
Participants will take 1 capsule Doxazosin 4mg XL each evening
Drug: Doxazosin XL
Other Names:
  • Cardozin XL 4mg Prolonged-release Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in peak nasal inspiratory from baseline as compared with acute and chronic dosing of doxazosin versus placebo
Time Frame: 12 hours; 3 to 5 weeks
12 hours; 3 to 5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Nasal histamine challenge response as measured by peak nasal inspiratory flow after chronic dosing
Time Frame: 12 hours; 3 to 5 weeks
12 hours; 3 to 5 weeks
Nasal airways resistance after single and chronic dosing
Time Frame: 12 hours; 3 to 5 weeks
12 hours; 3 to 5 weeks
Domiciliary peak nasal inspiratory measurements after chronic dosing
Time Frame: 12 hours; 3 to 5 weeks
12 hours; 3 to 5 weeks
Symptoms after chronic dosing
Time Frame: 12 hours; 3 to 5 weeks
12 hours; 3 to 5 weeks
Mini Rhinoconjunctivitis Quality of Life Questionnaire after chronic dosing
Time Frame: 24 hours; 3 to 5 weeks
24 hours; 3 to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Investigators

  • Principal Investigator: Brian J Lipworth, MD, University of Dundee
  • Principal Investigator: Arvind Manoharan, MBChB, University of Dundee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 16, 2013

First Submitted That Met QC Criteria

September 18, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012RC14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergic Rhinitis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe