Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway inflammation with topical steroids improves the twitchiness of the airways (hyperresponsiveness) and overall asthma control. The use of inhaled corticosteroids reduces symptoms, severity of asthma attacks, improves quality of life, and reduces asthma related deaths. Similarly, treatment of rhinitis with nasal steroids reduces symptoms and improves quality of life. While there is evidence that combined treatment of the nose and the lungs with topical steroids improves symptoms and underlying inflammation, it is unclear whether such control can be achieved using a smaller dose of inhaled steroid in combination with nasal steroid. It is therefore the intention of this study to evaluate if combination steroid therapy (nose and lungs) has a steroid sparing effect in patients with asthma and rhinitis using sensitive markers of airway inflammation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Intranasal Fluticasone Plus Azelastine on Airway Inflammation in Patients With Asthma & Allergic Rhinitis

NCT02953106

Asthma, Allergic Rhinitis,Allergic Allergy

TERMINATED PHASE4

Observed Outcomes Associated With Fluticasone Propionate/Salmeterol Xinafoate or Inhaled Corticosteroids in Asthma Patients

NCT01431924

Asthma

COMPLETED

Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma

NCT00606242

Asthma

COMPLETED PHASE4

Should Non-eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?

NCT00509197

Asthma

TERMINATED NA

Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)

NCT00424008

Asthma

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Allergic Rhinitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low Dose

One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg) and 1 puff of inhaled Placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.

Group Type EXPERIMENTAL

Fluticasone Evohaler pMDI

Intervention Type DRUG

One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)

Placebo

Intervention Type DRUG

1 puff of inhaled Placebo twice a day

Placebo intranasal spray

Intervention Type DRUG

placebo intranasal spray 2 squirts each nostril once a day

Combined

One puff of inhaled fluticasone propionate Evohaler pMDI 50 µg twice a day (Total daily FP dose 100 µg) and 1 puffs of Placebo twice a day with intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts each nostril once a day (i.e. total intranasal FP daily dose 200ug).

Group Type EXPERIMENTAL

Fluticasone Evohaler pMDI

Intervention Type DRUG

One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)

Placebo

Intervention Type DRUG

1 puff of inhaled Placebo twice a day

fluticasone propionate (Flixonase®)

Intervention Type DRUG

intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts

High dose

One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg) and 1 puff of inhaled placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

1 puff of inhaled Placebo twice a day

Fluticasone Evohaler

Intervention Type DRUG

One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg)

Placebo intranasal spray

Intervention Type DRUG

placebo intranasal spray 2 squirts each nostril once a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluticasone Evohaler pMDI

One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)

Intervention Type DRUG

Placebo

1 puff of inhaled Placebo twice a day

Intervention Type DRUG

Fluticasone Evohaler

One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg)

Intervention Type DRUG

Placebo intranasal spray

placebo intranasal spray 2 squirts each nostril once a day

Intervention Type DRUG

fluticasone propionate (Flixonase®)

intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Mild to moderate atopic asthmatics with FEV1 ≥ 60% on ≤ 1000 ug BDP and concomitant persistent allergic rhinitis (SPT +ve and PC20 \< 4 mg/ml)
* Male or female aged 18-65 years
* Informed Consent
* Ability to comply with the requirements of the protocol

Exclusion Criteria

* Severe asthmatics as defined by an FEV1 ≤ 60% or PEF variability \> 30% or with continual daytime or nocturnal symptoms.
* Nasal Polyposis grade 2/3, deviated nasal septum ≥ 50%
* The use of oral corticosteroids within the last 3 months
* Recent respiratory tract infection (2 months)
* Significant concomitant respiratory disease
* Any other significant medical condition or investigation which may jeopardise the safety of the participant or the conduct of the protocol
* Any significant abnormal laboratory result as deemed by the investigators
* Pregnancy, planned pregnancy or lactation
* Known or suspected contra-indication to any of the IMP's
* Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No