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Completed

NCT Number: NCT00903227

Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

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.

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Key information

Conditions

Asthma Allergic Rhinitis Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asthma and Allergy Research Group, Ninewells Hospital and University of Dundee

Dundee, Angus, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone Evohaler pMDI

Drug

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

Placebo

Drug

1 puff of inhaled Placebo twice a day

Fluticasone Evohaler

Drug

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

Placebo intranasal spray

Drug

placebo intranasal spray 2 squirts each nostril once a day

fluticasone propionate (Flixonase®)

Drug

intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts

Primary outcomes

  1. methacholine PC20

    Time frame: 0, 2, 4, 6, 8, 10, 12 weeks

Secondary outcomes

  1. Spirometry

    Time frame: 0, 2, 4, 6, 8, 10, 12 weeks

  2. Juniper AQLQ

    Time frame: 0, 2, 4, 6, 8, 10, 12 weeks

  3. Fractionated Nitric Oxide

    Time frame: 0, 2, 4, 6, 8, 10, 12 weeks

  4. serum ECP

    Time frame: 0, 2, 4, 6, 8, 10, 12 weeks

  5. blood eosinophils

    Time frame: 0, 2, 4, 6, 8, 10, 12 weeks

  6. Overnight urinary cortisol creatinine

    Time frame: 0, 2, 4, 6, 8, 10, 12 weeks

  7. Peak Nasal Inspiratory Flow rate

    Time frame: 0, 2, 4, 6, 8, 10, 12 weeks

  8. Nasal Nitric Oxide

    Time frame: 0, 2, 4, 6, 8, 10, 12 weeks

  9. Juniper mini RQLQ

    Time frame: 0, 2, 4, 6, 8, 10, 12 weeks

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Registry information

Official study title

A Proof Of Concept Study To Assess The Steroid Sparing Effect Of Combined Nasal And Inhaled Corticosteroid In Patients With Asthma And Persistent Rhinitis

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 18, 2009
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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