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Fluticasone and Salmeterol in Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
ClinicalTrials.gov Identifier:
NCT01388595
First received: July 1, 2011
Last updated: June 16, 2012
Last verified: June 2012
History of Changes
  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: Salmetrol Xinofoate
Drug: Salmetrol and Fluticasone propionate combination inhaler
Drug: PLACEBO
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Change in Peak Nasal Inspiratory Flow (PNIF). [ Time Frame: Change from baseline at 1 week. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Nasal Quality of Life Scoring.

  • Nasal nitric oxide. [ Time Frame: Change from baseline at 1 week. ] [ Designated as safety issue: No ]
  • Nasal impulse oscillometry. [ Time Frame: Change from baseline at 1 week. ] [ Designated as safety issue: No ]
    Assessment of airway resistance.

  • Eosinophil cationic protein (ECP) [ Time Frame: Change from baseline at 1 week. ] [ Designated as safety issue: No ]
    Serum blood test

  • Overnight urinary cortisol/creatinine. [ Time Frame: Change from baseline at 1 week. ] [ Designated as safety issue: No ]

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: FP Drug: FLUTICASONE PROPRIONATE
1. Fluticasone Propionate 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: SM Drug: Salmetrol Xinofoate
Salmetrol Xinofoate 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
Active Comparator: FPSM Drug: Salmetrol and Fluticasone propionate combination inhaler
Salmetrol and Fluticasone propionate combination inhaler Product Name: Seretide 250 Evohaler® Manufacturer: Allan and Hanbury's Active ingredients: Fluticasone Propionate, Salmetrol Xinafoate Propellant: HFA 134a Dose: Fluticasone Propionate 250µg, Salmetrol Xinafoate 25µg per metered actuation, 2 actuation BD actuation giving a total dose of 500mg of FP and 50µg of SM per day through the spacer device with the customised nasal adaptor
Other Name: Treatment
Placebo Comparator: 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388595

Sponsors and Collaborators
University of Dundee
Investigators
Principal Investigator: Brian J Lipworth, MD University of Dundee, UK
  More Information

No publications provided by University of Dundee

Additional 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
Study First Received: July 1, 2011
Last Updated: June 16, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 22, 2013