Allergic RhinitisPhase 4MAN01NCT01946035
Alpha-Blockers in Allergic Rhinitis (MAN 01)
A Phase 4 study testing Doxazosin XL in people with Allergic Rhinitis, run by University of Dundee at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Doxazosin XL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Doxazosin XL, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxazosin XLDrug
Also called Cardozin XL 4mg Prolonged-release Tablets
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will take 1 capsule placebo each evening Receives: Other: Placebo |
| Doxazosin XL | Experimental | Participants will take 1 capsule Doxazosin 4mg XL each evening Receives: Drug: Doxazosin XL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak nasal inspiratory from baseline as compared with acute and chronic dosing of doxazosin versus placebo
Measured: 12 hours; 3 to 5 weeks
Secondary outcomes (5)
Nasal histamine challenge response as measured by peak nasal inspiratory flow after chronic dosing
Measured: 12 hours; 3 to 5 weeks
Nasal airways resistance after single and chronic dosing
Measured: 12 hours; 3 to 5 weeks
Domiciliary peak nasal inspiratory measurements after chronic dosing
Measured: 12 hours; 3 to 5 weeks
Symptoms after chronic dosing
Measured: 12 hours; 3 to 5 weeks
Mini Rhinoconjunctivitis Quality of Life Questionnaire after chronic dosing
Measured: 24 hours; 3 to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian J Lipworth, University of Dundee
- Investigators
- Brian J Lipworth, MD, Principal investigator, University of DundeeArvind Manoharan, MBChB, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946035
- Sponsor's protocol ID
- 2012RC14
- Acronym
- MAN01
- Status last verified
- Apr 2019
- First submitted
- 16 Sep 2013
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26741127
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01946035
- Acronym / sponsor ID
- MAN01 / 2012RC14
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants will take 1 capsule placebo each evening |
| Doxazosin XL | Experimental | Drug: Doxazosin XLParticipants will take 1 capsule Doxazosin 4mg XL each evening |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxazosin XLAlso: Cardozin XL 4mg Prolonged-release Tablets | Drug | Doxazosin XL |
| Placebo | Other | Placebo |
Primary outcome
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
5 secondary outcomes
Nasal histamine challenge response as measured by peak nasal inspiratory flow after chronic dosing
Time frame: 12 hours; 3 to 5 weeks
Nasal airways resistance after single and chronic dosing
Time frame: 12 hours; 3 to 5 weeks
Domiciliary peak nasal inspiratory measurements after chronic dosing
Time frame: 12 hours; 3 to 5 weeks
Symptoms after chronic dosing
Time frame: 12 hours; 3 to 5 weeks
Mini Rhinoconjunctivitis Quality of Life Questionnaire after chronic dosing
Time frame: 24 hours; 3 to 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Background: PubMed 26741127Manoharan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian J Lipworth, MD principal investigator
University of Dundee
Arvind Manoharan, MBChB principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxazosin XL in people with Allergic Rhinitis, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01946035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.