Effects of Intranasal Fluticasone Plus Azelastine on Airway Inflammation in Patients With Asthma & Allergic Rhinitis

NCT02953106 | Terminated Phase 4

• 1 other identifier: 2015-001093-17
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Single centre, double-blind, placebo controlled, adaptive design, cross-over trial. The primary objective is to assess the additive effects of using combined intranasal fluticasone propionate plus azelastine nasal spray on airway hyperresponsiveness. This is in patients with persistent asthma and allergic rhinitis, receiving inhaled steroid.

Conditions

Asthma, Allergic; Rhinitis,Allergic; Allergy

Keywords

Asthma; Rhinitis; Dymista; allergy

Outcome Measures

Primary Outcomes (1)

• Methacholine PC20

  The provocative concentration of methacholine required to produce a 20% drop (PC20) in forced expiratory volume in 1 second (FEV1)

  3-5 weeks

Secondary Outcomes (17)

• Exhaled nitric oxide (FeNO)

  3-5 weeks

• Forced expiratory volume in 1 second (FEV1)

  3-5 weeks

• Morning peak expiratory flow (PEF)

  3-5 weeks

• Airway resistance at 5Hz (R5)

  3-5 weeks

• Airway resistance at 20Hz (R20)

  3-5 weeks

Study Arms (2)

Azelastine-Fluticasone Nasal

ACTIVE COMPARATOR

137 micrograms azelastine hydrochloride / 50 micrograms fluticasone propionate per actuation. 1 squirt twice daily

Drug: Azelastine-Fluticasone Nasal

Placebos

PLACEBO COMPARATOR

contains the same components as Dymista nasal spray with the exception of the active ingredients. 1 squirt twice daily.

Drug: Placebos

Interventions

Azelastine-Fluticasone Nasal DRUG

137 micrograms azelastine hydrochloride / 50 micrograms fluticasone propionate

Also known as: Dymista

Azelastine-Fluticasone Nasal

Placebos DRUG

Placebo nasal spray

Placebos

Eligibility Criteria

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

You may qualify if:

• Male or female volunteers, aged 18 years and above, with persistent asthma and allergic rhinitis
• On a minimum of 200μg BDP of Inhaled corticosteroid (ICS)
• FEV1 ≥ 60 % predicted
• Positive skin prick test, or record of elevated allergen-specific IgE to at least 1 perennial allergen
• Methacholine PC20 \< 8mg/ml at Visit 1
• Ability to give informed consent

You may not qualify if:

• Other respiratory diseases such as COPD, bronchiectasis or allergic bronchopulmonary aspergillosis (ABPA) which are considered to be significant in the opinion of the study physician Nasal polyps ≥ Grade 2
• An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement, or 3 months if hospital admission was required
• Any clinically significant medical condition that may endanger the health or safety of the participant. For example: Patients who have tuberculosis or any type of untreated infection or have had recent surgical operation or injury to the nose or mouth.
• Participation in another trial within 30 days before the commencement of the study
• Pregnancy or lactation
• Unable to comply with the procedures of the protocol
• Unable or unwilling to consent
• Taking prohibited medications as listed in section 6.7.2 Prohibited Medications
• Hypersensitivity to the active substances or to any of the excipients of Dymista Nasal Spray.

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic; Hypersensitivity; Rhinitis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections

Study Officials

• Brian Lipworth, MD

  Scottish Centre for Respiratory Reseach

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 2, 2016
• Study Start: January 20, 2017
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)