search
Back to results

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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Doxazosin XL
Placebo
Sponsored by
University of Dundee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Brian Lipworth

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Doxazosin XL

Arm Description

Participants will take 1 capsule placebo each evening

Participants will take 1 capsule Doxazosin 4mg XL each evening

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nasal histamine challenge response as measured by peak nasal inspiratory flow after chronic dosing
Nasal airways resistance after single and chronic dosing
Domiciliary peak nasal inspiratory measurements after chronic dosing
Symptoms after chronic dosing
Mini Rhinoconjunctivitis Quality of Life Questionnaire after chronic dosing

Full Information

First Posted
September 16, 2013
Last Updated
April 10, 2019
Sponsor
University of Dundee
search

1. Study Identification

Unique Protocol Identification Number
NCT01946035
Brief Title
Alpha-Blockers in Allergic Rhinitis (MAN 01)
Acronym
MAN01
Official Title
A Proof of Concept Study in Allergic Rhinitis, to Evaluate the Differential Effects Between Single and Chronic Dosing of Doxazosin on Nasal Airway Calibre
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take 1 capsule placebo each evening
Arm Title
Doxazosin XL
Arm Type
Experimental
Arm Description
Participants will take 1 capsule Doxazosin 4mg XL each evening
Intervention Type
Drug
Intervention Name(s)
Doxazosin XL
Other Intervention Name(s)
Cardozin XL 4mg Prolonged-release Tablets
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Nasal histamine challenge response as measured by peak nasal inspiratory flow after chronic dosing
Time Frame
12 hours; 3 to 5 weeks
Title
Nasal airways resistance after single and chronic dosing
Time Frame
12 hours; 3 to 5 weeks
Title
Domiciliary peak nasal inspiratory measurements after chronic dosing
Time Frame
12 hours; 3 to 5 weeks
Title
Symptoms after chronic dosing
Time Frame
12 hours; 3 to 5 weeks
Title
Mini Rhinoconjunctivitis Quality of Life Questionnaire after chronic dosing
Time Frame
24 hours; 3 to 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Lipworth, MD
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arvind Manoharan, MBChB
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brian Lipworth
City
Dundee
ZIP/Postal Code
DD1 3AU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26741127
Citation
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.
Results Reference
background

Learn more about this trial

Alpha-Blockers in Allergic Rhinitis (MAN 01)

We'll reach out to this number within 24 hrs