Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

This study has been completed.
Sponsor:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00903227
First received: May 14, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Asthma
Allergic Rhinitis
Drug: Fluticasone Evohaler pMDI
Drug: Placebo
Drug: Fluticasone Evohaler
Drug: Placebo intranasal spray
Drug: fluticasone propionate (Flixonase®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • methacholine PC20 [ Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spirometry [ Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks ] [ Designated as safety issue: No ]
  • Juniper AQLQ [ Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks ] [ Designated as safety issue: No ]
  • Fractionated Nitric Oxide [ Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks ] [ Designated as safety issue: No ]
  • serum ECP [ Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks ] [ Designated as safety issue: No ]
  • blood eosinophils [ Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks ] [ Designated as safety issue: No ]
  • Overnight urinary cortisol creatinine [ Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks ] [ Designated as safety issue: Yes ]
  • Peak Nasal Inspiratory Flow rate [ Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks ] [ Designated as safety issue: No ]
  • Nasal Nitric Oxide [ Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks ] [ Designated as safety issue: No ]
  • Juniper mini RQLQ [ Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: December 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Fluticasone Evohaler pMDI
One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)
Drug: Placebo
1 puff of inhaled Placebo twice a day
Drug: Placebo intranasal spray
placebo intranasal spray 2 squirts each nostril once a day
Experimental: 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).
Drug: Fluticasone Evohaler pMDI
One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)
Drug: Placebo
1 puff of inhaled Placebo twice a day
Drug: fluticasone propionate (Flixonase®)
intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts
Experimental: 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.
Drug: Placebo
1 puff of inhaled Placebo twice a day
Drug: Fluticasone Evohaler
One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg)
Drug: Placebo intranasal spray
placebo intranasal spray 2 squirts each nostril once a day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903227

Locations
United Kingdom
Asthma and Allergy Research Group, Ninewells Hospital and University of Dundee
Dundee, Angus, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Investigators
Principal Investigator: Arun Nair, MBBS University of Dundee
Study Director: Brian Lipworth, MD University of Dundee
  More Information

Publications:
Responsible Party: Dr Arun Nair, University of Dundee
ClinicalTrials.gov Identifier: NCT00903227     History of Changes
Other Study ID Numbers: NAI03, EudraCT number: 2005-005557-22
Study First Received: May 14, 2009
Last Updated: May 14, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:
Asthma
Allergic rhinitis
fluticasone
methacholine

Additional relevant MeSH terms:
Asthma
Rhinitis
Rhinitis, Allergic, Perennial
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 31, 2014