Trial reportAllergy2016
A randomized DBPC trial to determine the optimal effective and safe dose of a SLIT-birch pollen extract for the treatment of allergic rhinitis: results of a phase II study.
Trial report in Allergy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01639768 (A Randomized, Double-blind, Placebo-controlled Study to Determine Safety, Tolerability and the Optimal Effective Dose of SUBLIVAC FIX Birch in Patients With Allergic Rhinitis/Rhinoconjunctivitis Caused by Birch Pollen), which is not on this map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled Study to Determine Safety, Tolerability and the Optimal Effective Dose of SUBLIVAC FIX Birch in Patients With Allergic Rhinitis/Rhinoconjunctivitis Caused by Birch Pollen
Who cites it
17 citing papers in PubMed, 46 citations in OpenAlex.
- First-in-human phase 2 trial with mite allergoids coupled to mannan in subcutaneous and sublingual immunotherapy.Allergy · 2022Trial
- Efficacy and safety of birch pollen allergoid subcutaneous immunotherapy: A 2-year double-blind, placebo-controlled, randomized trial plus 1-year open-label extension.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2019Trial
- Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy.Allergy · 2018Trial
- Trial
- Tolerability and Safety of Sublingual Immunotherapy in Patients with Tree Pollen Allergy in Daily Practice-An Open, Prospective, Non-Interventional Study.Journal of clinical medicine · 2023Article
- [Value of allergen nasal provocation test in assessment of the efficacy of house dust mites specific immunotherapy].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2023Article
- Immune mechanisms induced by sublingual immunotherapy in allergic respiratory diseases.Clinical and experimental immunology · 2022Review
- Allergen provocation tests in respiratory research: building on 50 years of experience.The European respiratory journal · 2022Review
- Article
- The Natural Products Targeting on Allergic Rhinitis: From Traditional Medicine to Modern Drug Discovery.Antioxidants (Basel, Switzerland) · 2021Review
- Dogmas, challenges, and promises in phase III allergen immunotherapy studies.The World Allergy Organization journal · 2021Review
- Allergen immunotherapy phase II trials: Challenges in dose finding.Allergologie select · 2019Review
- Shortened up-dosing with sublingual immunotherapy drops containing tree allergens is well tolerated and elicits dose-dependent clinical effects during the first pollen season.The World Allergy Organization journal · 2019Article
- Sublingual allergen immunotherapy for respiratory allergy: a systematic review.Drugs in context · 2018Article
- Early nonreactivity in the conjunctival provocation test predicts beneficial outcome of sublingual immunotherapy.Clinical and translational allergy · 2018Article
- Clinical practice recommendations for allergen-specific immunotherapy in children: the Italian consensus report.Italian journal of pediatrics · 2017Review
- Sublingual versus subcutaneous immunotherapy: patient adherence at a large German allergy center.Patient preference and adherence · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSublingual immunotherapy (SLIT) is a potential efficacious and safe treatment option for patients with respiratory, IgE-mediated allergic diseases. A combined tolerability, dose-finding study with a sublingual liquid birch pollen preparation (SB) was conducted.
methodsTwo hundred and sixty-nine adults with birch-pollen-induced AR were randomized to placebo, SB: 3333, 10,000, 20,000 or 40,000 AUN/ml. Differences in symptom scores following a titrated nasal provocation test (TNPT) at baseline and after 5 months of treatment were determined. Safety, tolerability, birch-pollen-specific immunoglobulin levels and peak nasal inspiratory flow (PNIF) were also measured (all measures determined outside the birch pollen season).
resultsIn all treatment groups, an improvement in symptom scores after treatment compared to baseline was observed, with an additional stepwise improvement in the active groups compared to placebo, which was significant in high-dose groups (P = 0.008 and P < 0.001, respectively). For this primary endpoint, a significant linear dose-response curve was observed: the higher the dose, the better the improvement observed. Likewise, active treatment resulted in an increase in PNIF and serum IgG levels compared to placebo. The highest improvements were found in the 40,000 AUN/ml group. All active dosages resulted in more adverse reactions than placebo, which were mainly mild and well-controlled.
conclusionsA multicentre trial evaluated the dose-response and tolerability of SB. All active treatment groups showed better responses than placebo for both primary and secondary parameters. The results indicate that, within the studied dose range, SB 40,000 AUN/ml is the most optimal effective and safe dose (ClinicalTrials.gov: NCT01639768).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.