A Multicenter, Prospective, Noninterventional Study in a Norwegian Cohort of Patients with Moderate-to-Severe Allergic Rhinitis Treated with MP-AzeFlu
Background Allergic Rhinitis and its Impact on Asthma guidelines recently recommended a treatment strategy for allergic rhinitis (AR) based on disease control rather than symptom severity by using a visual analog scale (VAS) to categorize control Objectives To evaluate the effectiveness of MP-AzeFlu...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2017-10-01
|
| Series: | Allergy & Rhinology |
| Online Access: | https://doi.org/10.2500/ar.2017.8.0216 |
| _version_ | 1818333466311262208 |
|---|---|
| author | Ralph Dollner Ph.D. Petter Lorentz Larsen M.D. Sinan Dheyauldeen M.D. Sverre Steinsvåg M.D. |
| author_facet | Ralph Dollner Ph.D. Petter Lorentz Larsen M.D. Sinan Dheyauldeen M.D. Sverre Steinsvåg M.D. |
| author_sort | Ralph Dollner Ph.D. |
| collection | DOAJ |
| description | Background Allergic Rhinitis and its Impact on Asthma guidelines recently recommended a treatment strategy for allergic rhinitis (AR) based on disease control rather than symptom severity by using a visual analog scale (VAS) to categorize control Objectives To evaluate the effectiveness of MP-AzeFlu (Dymista ® ) by using this VAS in routine clinical practice in Norway. MP-AzeFlu comprises a novel formulation that contains azelastine hydrochloride, fluticasone propionate and excipients delivered in a single spray. Methods This multicenter, prospective, noninterventional study enrolled patients (n = 160) with moderate-to-severe AR and acute symptoms who were eligible to receive treatment with MP-AzeFlu according to its summary of product characteristics. Patients assessed symptom severity by using a VAS from 0 (not at all bothersome) to 100 mm (very bothersome) in the morning before MP-AzeFlu use on days 0, 1, 3, 7, and after ~14 days. On day 3, the patients assessed their level of disease control as well controlled, partly controlled, or uncontrolled. The proportion of Norwegian patients who achieved defined VAS score cutoffs for “well-controlled” and “partly controlled” AR were also calculated. Results MP-AzeFlu reduced the mean ± standard deviation VAS score from 68.1 ± 16.4 mm at baseline to 37.4 ± 25.9 mm on the last day, a reduction of 30.8 ± 27.2 mm. The results were consistent, irrespective of disease severity, phenotype (i.e., seasonal AR [SAR], perennial AR [PAR], SAR plus PAR, unknown) or age (i.e., 12–17, 18–65, and >65 years). Of the patients (with recorded data), 88.1% considered their symptoms to be partly or well controlled at day 3; and 19.5, 32.0, 50.0, and 61.0% of the patients achieved a ≤38 mm well-controlled VAS score cutoff on days 1, 3, 7, and the last day, respectively. Conclusions MP-AzeFlu provided rapid sustained symptom control in a routine clinical practice in Norway, which provided support for its effectiveness for the treatment of AR in real life. |
| first_indexed | 2024-12-13T13:52:05Z |
| format | Article |
| id | doaj.art-2a7e340c6ecc4538b72bed5d73ac9e31 |
| institution | Directory Open Access Journal |
| issn | 2152-6567 |
| language | English |
| last_indexed | 2024-12-13T13:52:05Z |
| publishDate | 2017-10-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Allergy & Rhinology |
| spelling | doaj.art-2a7e340c6ecc4538b72bed5d73ac9e312022-12-21T23:43:06ZengSAGE PublishingAllergy & Rhinology2152-65672017-10-01810.2500/ar.2017.8.0216A Multicenter, Prospective, Noninterventional Study in a Norwegian Cohort of Patients with Moderate-to-Severe Allergic Rhinitis Treated with MP-AzeFluRalph Dollner Ph.D.0Petter Lorentz Larsen M.D.1Sinan Dheyauldeen M.D.2Sverre Steinsvåg M.D.3 Department of Otorhinolaryngology, Division of Head, Neck and Reconstructive Surgery, Oslo University Hospital Rikshospitalet, Oslo, Norway Bserum Øre Nese Halsklinikk, Bekkestua, Norway Department of Otorhinolaryngology, Division of Head, Neck and Reconstructive Surgery, Oslo University Hospital Rikshospitalet, Oslo, Norway Sørlandet Hospital, Department of Otolaryngology, Head and Neck Surgery, Kristiansand, NorwayBackground Allergic Rhinitis and its Impact on Asthma guidelines recently recommended a treatment strategy for allergic rhinitis (AR) based on disease control rather than symptom severity by using a visual analog scale (VAS) to categorize control Objectives To evaluate the effectiveness of MP-AzeFlu (Dymista ® ) by using this VAS in routine clinical practice in Norway. MP-AzeFlu comprises a novel formulation that contains azelastine hydrochloride, fluticasone propionate and excipients delivered in a single spray. Methods This multicenter, prospective, noninterventional study enrolled patients (n = 160) with moderate-to-severe AR and acute symptoms who were eligible to receive treatment with MP-AzeFlu according to its summary of product characteristics. Patients assessed symptom severity by using a VAS from 0 (not at all bothersome) to 100 mm (very bothersome) in the morning before MP-AzeFlu use on days 0, 1, 3, 7, and after ~14 days. On day 3, the patients assessed their level of disease control as well controlled, partly controlled, or uncontrolled. The proportion of Norwegian patients who achieved defined VAS score cutoffs for “well-controlled” and “partly controlled” AR were also calculated. Results MP-AzeFlu reduced the mean ± standard deviation VAS score from 68.1 ± 16.4 mm at baseline to 37.4 ± 25.9 mm on the last day, a reduction of 30.8 ± 27.2 mm. The results were consistent, irrespective of disease severity, phenotype (i.e., seasonal AR [SAR], perennial AR [PAR], SAR plus PAR, unknown) or age (i.e., 12–17, 18–65, and >65 years). Of the patients (with recorded data), 88.1% considered their symptoms to be partly or well controlled at day 3; and 19.5, 32.0, 50.0, and 61.0% of the patients achieved a ≤38 mm well-controlled VAS score cutoff on days 1, 3, 7, and the last day, respectively. Conclusions MP-AzeFlu provided rapid sustained symptom control in a routine clinical practice in Norway, which provided support for its effectiveness for the treatment of AR in real life.https://doi.org/10.2500/ar.2017.8.0216 |
| spellingShingle | Ralph Dollner Ph.D. Petter Lorentz Larsen M.D. Sinan Dheyauldeen M.D. Sverre Steinsvåg M.D. A Multicenter, Prospective, Noninterventional Study in a Norwegian Cohort of Patients with Moderate-to-Severe Allergic Rhinitis Treated with MP-AzeFlu Allergy & Rhinology |
| title | A Multicenter, Prospective, Noninterventional Study in a Norwegian Cohort of Patients with Moderate-to-Severe Allergic Rhinitis Treated with MP-AzeFlu |
| title_full | A Multicenter, Prospective, Noninterventional Study in a Norwegian Cohort of Patients with Moderate-to-Severe Allergic Rhinitis Treated with MP-AzeFlu |
| title_fullStr | A Multicenter, Prospective, Noninterventional Study in a Norwegian Cohort of Patients with Moderate-to-Severe Allergic Rhinitis Treated with MP-AzeFlu |
| title_full_unstemmed | A Multicenter, Prospective, Noninterventional Study in a Norwegian Cohort of Patients with Moderate-to-Severe Allergic Rhinitis Treated with MP-AzeFlu |
| title_short | A Multicenter, Prospective, Noninterventional Study in a Norwegian Cohort of Patients with Moderate-to-Severe Allergic Rhinitis Treated with MP-AzeFlu |
| title_sort | multicenter prospective noninterventional study in a norwegian cohort of patients with moderate to severe allergic rhinitis treated with mp azeflu |
| url | https://doi.org/10.2500/ar.2017.8.0216 |
| work_keys_str_mv | AT ralphdollnerphd amulticenterprospectivenoninterventionalstudyinanorwegiancohortofpatientswithmoderatetosevereallergicrhinitistreatedwithmpazeflu AT petterlorentzlarsenmd amulticenterprospectivenoninterventionalstudyinanorwegiancohortofpatientswithmoderatetosevereallergicrhinitistreatedwithmpazeflu AT sinandheyauldeenmd amulticenterprospectivenoninterventionalstudyinanorwegiancohortofpatientswithmoderatetosevereallergicrhinitistreatedwithmpazeflu AT sverresteinsvagmd amulticenterprospectivenoninterventionalstudyinanorwegiancohortofpatientswithmoderatetosevereallergicrhinitistreatedwithmpazeflu AT ralphdollnerphd multicenterprospectivenoninterventionalstudyinanorwegiancohortofpatientswithmoderatetosevereallergicrhinitistreatedwithmpazeflu AT petterlorentzlarsenmd multicenterprospectivenoninterventionalstudyinanorwegiancohortofpatientswithmoderatetosevereallergicrhinitistreatedwithmpazeflu AT sinandheyauldeenmd multicenterprospectivenoninterventionalstudyinanorwegiancohortofpatientswithmoderatetosevereallergicrhinitistreatedwithmpazeflu AT sverresteinsvagmd multicenterprospectivenoninterventionalstudyinanorwegiancohortofpatientswithmoderatetosevereallergicrhinitistreatedwithmpazeflu |