Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01388595
Status:
COMPLETED
Last Update Posted:
2019-10-16
First Post:
2011-07-01
Brief Title:
Fluticasone and Salmeterol in Allergic Rhinitis
Sponsor:
University of Dundee
Organization:
University of Dundee
Study Overview
Official Title:
A Proof of Concept Study to Evaluate Effects of Intranasal Salmeterol and Fluticasone Given Alone and in Combination in Allergic Rhinitis
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
In vitro and ex vitro data have suggested that salmeterol may exhibit ligand independent activation of glucocorticoid receptors which might result in potentiation of fluticasone by salmeterol when given in combination
Although no such evidence of synergy was reported with fluticasone salmeterol combination in the nose with allergen challenge no data are available on nasal AMP challenge in the nose
This study compares the single and long term dosing effects of intranasal fluticasone alone salmeterol alone and fluticasone salmeterol combination on nasal AMP challenge in persistent allergic rhinitis sufferers
Nasal corticosteroidleukotriene receptor antagonist and anti histamine stopped for one week before the start of randomized treatment during the run in phase and wash out periods Intransal sodium cromoglycate spray provided for rescue use throughout the study but witheld for at least twenty four hours before challenge
Nasal AMP challenges performed at baseline after run-in and each washout and 12 hours after the first and last evening dose of the study medication A Zerostat Antistatic spacer Cipla Mumbai India used to administer the randomized treatments adapted with a nasal olive for intranasal use instead of the conventional mouthpiece
The randomized treatments given once daily at night time as follows placebo hydrofluoroalkane 2 puffs Cipla MumbaiIndia salmeterol-hydrofluoroalkane 2 puffs of 25 g Serevent Evohaler Allen and Hanburys Middlesex United Kingdom fluticasone- salmeterol hydrofluoroalkane 2 puffs of 25025 g Seretide Evohaler Allen and Hanburys and fluticasone-hydrofluoroalkane2 puffs of 250 g Flixotide Evohaler Allen and Hanburys
The double-blind randomization process computer generated from wwwrandomizationcom Trial drug randomization performed under the direct supervision of the clinical trial pharmacist at Ninewells University Hospital
Active fluticasonesalmeterol and fluticasone-salmeterol combination procured from GlaxoSmithKline Allen and Hanburys by the clinical trial pharmacy and matched placebo provided by Cipla
Following Informed Consent and screening visit participants provided with randomized labeled treatment packs with a single inhaler either active or placebo at each study treatment visit
Blinding of patients and investigators ensured by using identical colored actuators for each treatment and labeling of active or placebo canisters with trial-specific labels
Measurements made at 12 hours after the first and last dose of each randomized treatment
At initial screening nasal endoscopy performed to exclude significant nasal polyp disease greater than grade 1 concha bullosa and septal deviation
A Niox Flex nitric oxide analyzer Aerocrine AB Solna Sweden used to measure nasal nitric oxide The standard aspiration technique recommended by the American Thoracic SocietyEuropean Respiratory Society guidelines used with a unilateralnasal olive breath-holding and velum closure
For nasal AMP challenge PNIF measured before and every 5 minutes for 60 minutes after 4 squirts of 01 mL per actuation in each nostril of 400 mgmL of AMP ie 320-mg total dose delivered to the nose The maximum decrease in PNIF measured using an In-check Nasal Inspiratory Flow Meter Clement Clarke International Ltd Harlow United Kingdom
It has been shown that measuring PNIF PEAK NASAL INSPIRATORY FLOW response is more sensitive than measuring nasal airway resistance and is also more reproduciblePNIF correlates well vs symptoms in response to treatment in allergic rhinitis patients and has been shown to have a minimal clinically important difference of 5 Lmin
At screening patients instructed in the correct technique with particular attention to horizontal positioning of the meter a closed mouth with maximal peak nasal inspiratory effort and an adequate mask seal around the mouth and nose
Nasal impulse oscillometry measurements for nasal airway resistance at 5 Hz performed using a Jaeger MasterScreen impulse oscillometry system Erich Jaeger Hoechberg Germany
The total nasal symptom 4 TNS4 scores recorded at all visits with a total score of 12 for the sum of the 4 separate domains for nasal blockage run itch and sneeze each rated from 0 to 3
The Juniper Mini Rhinoconjunctivitis Quality of Life Questionnaire Mini-RQLQ completed by the participant immediately before and a week after each randomized treatment The global RQLQ is the mean of the 5 individual domains with individual domains scored from 0 to 6
Serum eosinophilic cationic protein measured using an enzyme-linked immunoassay technique UniCAP Sweden Diagnostics UK Ltd Milton Keyes United Kingdom
Although no such evidence of synergy was reported with fluticasone salmeterol combination in the nose with allergen challenge no data are available on nasal AMP challenge in the nose
This study compares the single and long term dosing effects of intranasal fluticasone alone salmeterol alone and fluticasone salmeterol combination on nasal AMP challenge in persistent allergic rhinitis sufferers
Nasal corticosteroidleukotriene receptor antagonist and anti histamine stopped for one week before the start of randomized treatment during the run in phase and wash out periods Intransal sodium cromoglycate spray provided for rescue use throughout the study but witheld for at least twenty four hours before challenge
Nasal AMP challenges performed at baseline after run-in and each washout and 12 hours after the first and last evening dose of the study medication A Zerostat Antistatic spacer Cipla Mumbai India used to administer the randomized treatments adapted with a nasal olive for intranasal use instead of the conventional mouthpiece
The randomized treatments given once daily at night time as follows placebo hydrofluoroalkane 2 puffs Cipla MumbaiIndia salmeterol-hydrofluoroalkane 2 puffs of 25 g Serevent Evohaler Allen and Hanburys Middlesex United Kingdom fluticasone- salmeterol hydrofluoroalkane 2 puffs of 25025 g Seretide Evohaler Allen and Hanburys and fluticasone-hydrofluoroalkane2 puffs of 250 g Flixotide Evohaler Allen and Hanburys
The double-blind randomization process computer generated from wwwrandomizationcom Trial drug randomization performed under the direct supervision of the clinical trial pharmacist at Ninewells University Hospital
Active fluticasonesalmeterol and fluticasone-salmeterol combination procured from GlaxoSmithKline Allen and Hanburys by the clinical trial pharmacy and matched placebo provided by Cipla
Following Informed Consent and screening visit participants provided with randomized labeled treatment packs with a single inhaler either active or placebo at each study treatment visit
Blinding of patients and investigators ensured by using identical colored actuators for each treatment and labeling of active or placebo canisters with trial-specific labels
Measurements made at 12 hours after the first and last dose of each randomized treatment
At initial screening nasal endoscopy performed to exclude significant nasal polyp disease greater than grade 1 concha bullosa and septal deviation
A Niox Flex nitric oxide analyzer Aerocrine AB Solna Sweden used to measure nasal nitric oxide The standard aspiration technique recommended by the American Thoracic SocietyEuropean Respiratory Society guidelines used with a unilateralnasal olive breath-holding and velum closure
For nasal AMP challenge PNIF measured before and every 5 minutes for 60 minutes after 4 squirts of 01 mL per actuation in each nostril of 400 mgmL of AMP ie 320-mg total dose delivered to the nose The maximum decrease in PNIF measured using an In-check Nasal Inspiratory Flow Meter Clement Clarke International Ltd Harlow United Kingdom
It has been shown that measuring PNIF PEAK NASAL INSPIRATORY FLOW response is more sensitive than measuring nasal airway resistance and is also more reproduciblePNIF correlates well vs symptoms in response to treatment in allergic rhinitis patients and has been shown to have a minimal clinically important difference of 5 Lmin
At screening patients instructed in the correct technique with particular attention to horizontal positioning of the meter a closed mouth with maximal peak nasal inspiratory effort and an adequate mask seal around the mouth and nose
Nasal impulse oscillometry measurements for nasal airway resistance at 5 Hz performed using a Jaeger MasterScreen impulse oscillometry system Erich Jaeger Hoechberg Germany
The total nasal symptom 4 TNS4 scores recorded at all visits with a total score of 12 for the sum of the 4 separate domains for nasal blockage run itch and sneeze each rated from 0 to 3
The Juniper Mini Rhinoconjunctivitis Quality of Life Questionnaire Mini-RQLQ completed by the participant immediately before and a week after each randomized treatment The global RQLQ is the mean of the 5 individual domains with individual domains scored from 0 to 6
Serum eosinophilic cationic protein measured using an enzyme-linked immunoassay technique UniCAP Sweden Diagnostics UK Ltd Milton Keyes United Kingdom
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None