Trial · NCT07904052
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) by means of the Subject's Diary | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The combination score of symptoms and medication required for symptom control in rhinitis/rhinoconjunctivitis for each subject during the trial will be obtained by means of the Subject's diary. RCSMS corresponds to the sum of Rhinitis/rhinoconjunctivitis Symptom Score (RSS) and Rhinitis/rhinoconjunctivitis Medication Score (RMS). The assessment criteria for each symptom shall be as follows: * 0 = No symptoms * 1 = Mild symptoms * 2 = Moderate * 3 = Severe The RSS will correspond to the sum of the six rhinitis/rhinoconjunctivitis symptoms (itchy/red eyes, watery eyes, sneezing, itchy nose, runny nose, blocked nose), divided by six: The final score will range from 0 to 3. RMS will correspond to the highest level of medication taken on this day. The final RMS score will range from 0 to 3. The daily RCSMS is calculated as RCSMS (0-6) = RSS (0-3) + RMS (0-3). |
| Secondary | Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The RSS will correspond to the sum of the six rhinitis/rhinoconjunctivitis (itchy/red eyes, watery eyes, sneezing, itchy nose, runny nose, blocked nose), symptoms divided by six: (SS1+SS2+SS3+SS4+SS5+SS6) /6. The final score will range from 0 to 3. The assessment criteria for each symptom shall be as follows: * 0 = No symptoms (no obvious symptoms). * 1 = Mild symptoms (trivial; the symptom is clearly present but not bothersome). * 2 = Moderate (annoying but not disabling or intolerable). * 3 = Severe (disabling and/or intolerable). The Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) will be obtained throughout the different trial periods for each subject by means of the Subject's Diary. |
| Secondary | Rhinitis/Rhinoconjunctivitis Medication Score (RMS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | RMS will correspond to the highest level of medication taken on this day. The final RMS score will range from 0 to 3. Medication to assess rhinitis/rhinoconjunctivitis: * Oral and/or topical (eyes or nose) non-sedative H1 antihistamines (H1A). * Intranasal corticosteroids (INS) with/ without H1A. * Oral corticosteroids (OCS) with/without INS, with/without H1A. The Rhinitis/Rhinoconjunctivitis Medication Score (RMS) will be obtained throughout the different trial periods for each subject by means of the Subject's Diary |
| Secondary | Asthma Combined Symptom and Medication Score (ACSMS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The Asthma-Combined Symptom and Medication Score (ACSMS) will be obtained throughout the different trial periods for each subject with asthma using the data from the Subject's Diary. The ACSMS will correspond to the sum of ASS and AMS and will be calculated as follows: ACSMS (0-6) = ASS (0-3) + AMS (0-3) The final score will range from 0 to 6 |
| Secondary | Asthma Symptom Score (ASS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The Asthma Symptom Score (ASS) will be obtained throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma by means of the Subject's Diary. Asthma symptoms are the following: * Cough. * Wheezing. * Shortness of breath or feeling of choking. * Chest tightness. The endpoint for each symptom will be as follows: * 0 = No symptoms (no obvious symptoms). * 1 = Mild symptoms (trivial; the symptom is clearly present but not bothersome). * 2 = Moderate (annoying but not disabling or intolerable). * 3 = Severe (disabling and/or intolerable). The ASS will correspond to the sum of the four asthma symptoms (cough, wheezing, shortness of breath or feeling of choking, and chest tightness) divided by four: (SS1+SS2+SS3+SS4) /4. The final score will range from 0 to 3. |
| Secondary | Asthma Medication Score (AMS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The asthma medication will be scored based on the therapeutic step in which the drugs are included in the GEMA 5.0 and GINA 2023 guidelines. The scoring method is detailed in the article entitled "Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal." In the present study, the asthma medication will be scored as follows: * Score 0.5: SABA as needed. * Score 1: Low dose ICS with/without SABA as needed. * Score 1.5: Low dose ICS + LABA or medium dose ICS with/without SABA as needed. * Score 2: Medium dose ICS+LABA with/without SABA as needed. * Score 2.5: High dose ICS+LABA with/without SABA as needed. * Score 3: High dose ICS+LABA + systemic corticosteroids with/without LTRA with/without SABA as needed. The AMS will correspond to the highest level of medication taken on this day. The final score will range from 0 to 3. |
| Secondary | Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS) will be obtained throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma using the data from the Subject's Diary. The ARSS will correspond to the sum of RSS and ASS and will be calculated as follows: ARSS (0-6) = RSS (0-3) + ASS (0-3) The final score will range from 0 to 6. |
| Secondary | Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS) will be obtained throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma using the data from the Subject's Diary. The ARMS will correspond to the sum of RMS and AMS and will be calculated as follows: ARMS (0-6) = RMS (0-3) + AMS (0-3) The final score will range from 0 to 6. |
| Secondary | Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS) will be counted throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma using the data from the Subject's Diary. The ARCSMS will correspond to the sum of RCSMS and ACSMS and will be calculated as follows: ARCMS (0-12) = RCSMS (0-6) + ACSMS (0-6) The final score will range from 0 to 12. |
| Secondary | Asthma exacerbations | From visit 1 to the end of treatment at 12 months | Time to first asthma exacerbation, number, duration, and severity |
| Secondary | Immunological parameters in blood samples | In Baseline Visit or Visit 1 and in the Final visit | Total IgE Specific IgE and IgG4 Specific IgE/Total IgE ratio Anti-Saccharomyces cerevisiae antibodies (ASCA) (IgA and IgG) |
| Secondary | Allergen profiling (ALEX technique) | At the end of the study | Allergen profiling assessed using the Allergy Explorer (ALEX) multiplex assay to determine sensitization patterns to allergen extracts and molecular allergen components. Results will be used to characterize participants' allergen sensitization profiles. |
| Secondary | Asthma Quality of Life Questionnaire (AQLQ) | Baseline Visit, Additional Baseline visit, visit 3, visit 6, visit 9 and visit 12 | The Asthma Quality of Life Questionnaire (AQLQ) consists of 32 items and 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Each item is scored from 1 ("severe impairment") to 7 ("no impairment"). This questionnaire shall be completed by the subject at BV (subjects no sensitised to pollens or sensitised to pollens who do not have to attend the ABV), ABV (subjects sensitised to pollens who have to attend this visit), V3, V6, V9, and V12. |
| Secondary | Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Baseline Visit, Additional Baseline visit, visit 3, visit 6, visit 9 and visit 12 | The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) consists of 28 items (questions) and 7 domains (Activities Limitation, Sleep Problems, Non-Nose/Eye Symptoms, Practical Problems, Nose Symptoms, Eye Symptoms and Emotional Function). The score for each item for all domains, except for the emotional function domain, ranges from 0 ("not troubled") to 6 ("extremely troubled"). The score for the emotional domain ranges from 0 ("Never") to 6 ("Always"). This questionnaire shall be completed by the subject at BV (subjects no sensitised to pollens or sensitised to pollens who do not have to attend the ABV), ABV (subjects sensitised to pollens who have to attend this visit), V3, V6, V9, and V12. |
| Secondary | Asthma Control Questionnaire (GINA 2023) | Baseline visit and visit 12 | The Asthma Control Questionnaire (GINA 2023) consists of 4 questions. To assess symptom control, the investigator will ask about the following in the past four weeks: frequency of asthma symptoms (days per week), any night waking due to asthma or limitation of activity and, for patients using a SABA reliever, frequency of its use for relief of symptoms. The interpretation of the answered questions is as follows: * Well controlled asthma: All answered questions are "No" * Partly controlled asthma: 2 answered questions are "Yes" * Uncontrolled: 3-4 answered questions are "Yes" This questionnaire shall be completed by the subject at BV, and V12 |
| Secondary | Visual Analogue Scale (VAS) | Baseline Visit, Additional Baseline visit, visit 3, visit 6, visit 9 and visit 12 | The visual analogue scale is a 10 cm straight line, where the left end means that the subject feels very well, and the right end means that the subject feels very bad. * Subject's VAS, where the subject will mark a dot on the line that matches his or her health status with respect to allergy symptoms. * Investigator's VAS, where the investigator will mark a dot on the line that matches the subject's health status with respect to allergy symptoms. The VAS shall be completed by the participant and investigator at BV (subjects no sensitised to pollens or sensitised to pollens who do not have to attend the ABV), ABV (subjects sensitised to pollens who have to attend this visit), V3, V6, V9 and V12 in separate documents. |
| Secondary | Consumption of health resources | From enrollment to the end of treatment at 12 months | For each subject, the number of times during the study period that he/she has performed the following due to allergy symptoms shall be counted: * has visited the general practitioner. * has made an unscheduled visit to a specialist. * went to the emergency room. * has been hospitalised. * needed to contact the doctor by telephone. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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