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Fluticasone and Salmeterol in Allergic Rhinitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01388595
First Posted: July 6, 2011
Last Update Posted: April 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
  Purpose
Allergic rhinitis is an under diagnosed global health problem which affects up to 25% of the population worldwide. It has been reported as being one of the 10 most common causes for attendance to primary care clinics. It is clinically defined as a symptomatic disorder of the nose induced by an IgE mediated inflammation following allergen exposure of the membranes lining the nose and is characterized by varying combinations of nasal symptoms including sneezing, nasal blockage, rhinorrhoea and itching. Intra nasal corticosteroids form the cornerstone of anti-inflammatory therapy in allergic rhinitis and there is increasing interest in the role of intranasal beta 2 agonists in the management of allergic rhinitis. The question therefore arises as to whether salmeterol exhibits such synergistic activity in the nose in terms of potentiating the steroid response of fluticasone.

Condition Intervention Phase
Allergic Rhinitis Drug: FLUTICASONE PROPRIONATE Drug: Salmeterol Drug: PLACEBO Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Proof of Concept Study to Evaluate Effects of Intranasal Salmeterol and Fluticasone Given Alone and in Combination in Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Brian J Lipworth, University of Dundee:

Primary Outcome Measures:
  • Change in Peak Nasal Inspiratory Flow (PNIF). [ Time Frame: Change from baseline at 1 week. ]
    Maximum change in PNIF following nasal adenosine monophoshate (AMP) challenge testing for active groups versus placebo.. Data will be presented as % change between groups.


Secondary Outcome Measures:
  • Nasal symptom scores. [ Time Frame: Change from baseline at 1 week. ]
    Nasal Quality of Life Scoring.

  • Nasal nitric oxide. [ Time Frame: Change from baseline at 1 week. ]
  • Nasal impulse oscillometry. [ Time Frame: Change from baseline at 1 week. ]
    Assessment of airway resistance.

  • Eosinophil cationic protein (ECP) [ Time Frame: Change from baseline at 1 week. ]
    Serum blood test

  • Overnight urinary cortisol/creatinine. [ Time Frame: Change from baseline at 1 week. ]

Enrollment: 23
Study Start Date: November 2006
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluticasone Proprionate
The participants will be randomised and at each study visit, will receive a single inhaler which can either be active or placebo.
Drug: FLUTICASONE PROPRIONATE
1. Fluticasone Propionate (FP) Product name: Flixotide Evohaler® Manufacturer: Allan and Hanbury's Active ingredients: Fluticasone Propionate Propellant: HFA 134a Dose: 250μg per actuation giving a total dose of 500µg per day through the spacer device with the customised nasal adaptor.
Other Name: Treatment
Active Comparator: Salmeterol
The participants will be randomised and at each study visit, will receive a single inhaler which can either be active or placebo.
Drug: Salmeterol
Salmeterol Product Name: Serevent® Manufacturer: Allan and Hanbury's Active ingredients: Salmetrol Xinafoate Propellant: HFA 134a Dose: 25μg per actuation giving a total dose of 50µg per day through the spacer device with the customised nasal adaptor
Other Name: Treatment
Placebo Comparator: placebo
The participants will be randomised and at each study visit, will receive a single inhaler which can either be active or placebo.
Drug: PLACEBO
4. Placebo inhaler to SM, FP, SM+FP Manufacturer: Cipla Ltd Active ingredients: None Propellants: HFA 134a Imported & QP release tested in UK : DHP Clinical supplies, Powys, UK
Other Name: Treatment

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Persistent allergic rhinitis without asthma.
  2. Atopy to at least 1 allergen on SPT.
  3. ≥ 20% drop in PNIF following nasal AMP challenge
  4. Male to female aged 18-65
  5. Informed Consent
  6. Ability to comply with the protocol

Exclusion Criteria:

  1. Severe allergic rhinitis as defined by those in whom there are symptoms which significantly impair day to day activities on QOL questionnaire.
  2. Nasal Polyposis grade 2/3, deviated nasal septum ≥ 50%
  3. PNIF < 60 litres/min
  4. The use of oral corticosteroids within the last 3 months.
  5. Recent respiratory tract / sinus infection (2 months).
  6. Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
  7. Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol.
  8. Any significant abnormal laboratory result as deemed by the investigators
  9. Pregnancy, planned pregnancy or lactation
  10. Known or suspected contra-indication to any of the IMP's
  11. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388595


Locations
United Kingdom
Asthma and Allergy Research Group, University of Dundee
Dundee, United Kingdom, DD1 3AU
Sponsors and Collaborators
University of Dundee
Investigators
Principal Investigator: Brian J Lipworth, MD University of Dundee, UK
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian J Lipworth, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT01388595     History of Changes
Other Study ID Numbers: NAI002
First Submitted: July 1, 2011
First Posted: July 6, 2011
Last Update Posted: April 22, 2014
Last Verified: December 2013

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action