Fluticasone and Salmeterol in Allergic Rhinitis

NCT01388595 | Completed Phase 4 DMC

• 1 other identifier: NAI002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in Peak Nasal Inspiratory Flow (PNIF).

  Maximum change in PNIF following nasal adenosine monophoshate (AMP) challenge testing for active groups versus placebo.. Data will be presented as % change between groups.

  Change from baseline at 1 week.

Secondary Outcomes (5)

• Nasal symptom scores.

  Change from baseline at 1 week.

• Nasal nitric oxide.

  Change from baseline at 1 week.

• Nasal impulse oscillometry.

  Change from baseline at 1 week.

• Eosinophil cationic protein (ECP)

  Change from baseline at 1 week.

• Overnight urinary cortisol/creatinine.

  Change from baseline at 1 week.

Study Arms (3)

Fluticasone Proprionate

ACTIVE COMPARATOR

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

Salmeterol

ACTIVE COMPARATOR

The participants will be randomised and at each study visit, will receive a single inhaler which can either be active or placebo.

Drug: Salmeterol

placebo

PLACEBO COMPARATOR

The participants will be randomised and at each study visit, will receive a single inhaler which can either be active or placebo.

Drug: PLACEBO

Interventions

FLUTICASONE PROPRIONATE DRUG

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.

Also known as: Treatment

Fluticasone Proprionate

Salmeterol DRUG

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

Also known as: Treatment

Salmeterol

PLACEBO DRUG

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

Also known as: Treatment

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe allergic rhinitis as defined by those in whom there are symptoms which significantly impair day to day activities on QOL questionnaire.
• Nasal Polyposis grade 2/3, deviated nasal septum ≥ 50%
• PNIF \< 60 litres/min
• The use of oral corticosteroids within the last 3 months.
• Recent respiratory tract / sinus infection (2 months).
• Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
• 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.
• 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.

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Asthma and Allergy Research Group, University of Dundee

Dundee, DD1 3AU, United Kingdom

Location

Related Publications (1)

• Lipworth BJ, Short P, Burns P, Nair A. Effects of intranasal salmeterol and fluticasone given alone and in combination in persistent allergic rhinitis. Ann Allergy Asthma Immunol. 2012 Jan;108(1):54-59. doi: 10.1016/j.anai.2011.10.001. Epub 2011 Nov 2.

  PMID: 22192967 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Therapeutics; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Brian J Lipworth, MD

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 6, 2011
• Study Start: November 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)