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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004169-42 | EudraCT Number |
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Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough.
Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1817080 dose A BID | Experimental | Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks. |
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| BAY1817080 dose B BID | Experimental | Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks. |
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| BAY1817080 dose C BID | Experimental | Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks. |
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| Placebo | Placebo Comparator | Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1817080 | Drug | Study drug BAY1817080 will be administered orally as tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 24-hour Cough Count After 12 Weeks of Intervention | The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. For the ratio between the geometric means of 24-hour cough count, the geometric mean of 24-hour cough count after 12 weeks of intervention was divided by the geometric mean of 24-hour cough count at baseline. btw = between geo = geometric | From baseline up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Cough Count After 12 Weeks of Intervention | The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. The change from baseline in 24-hour cough count was calculated by the geometric mean of 24-hour cough count after 12 weeks of intervention minus the geometric mean at baseline divided by the geometric mean at baseline. The percentage of participants with a reduction of ≥30% is shown |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Allergy & Asthma Medical Group & Research Center | Los Angeles | California | 90025 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34978027 | Background | Fletcher MC. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis. Purinergic Signal. 2022 Mar;18(1):1-3. doi: 10.1007/s11302-021-09831-5. Epub 2022 Jan 3. No abstract available. | |
| 40498172 | Derived | Trigg A, Clarke N, Gerlinger C, Krahn U, Gater A, Haberland C. Psychometric validation of the severity of chronic cough diary, leicester cough questionnaire, and a cough severity visual analogue scale in patients with refractory chronic cough. J Patient Rep Outcomes. 2025 Jun 11;9(1):65. doi: 10.1186/s41687-025-00888-z. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Overall, 399 participants were screened, 89 of whom were screening failures. The remaining 310 participatns were randomized to 4 treatment groups (75 to eliapixant 25 mg BID, 78 to eliapixant 75 mg BID, 80 to eliapixant 150 mg BID, and 77 to placebo).
The study was conducted at 99 centers in 19 countries/regions with first participant first visit on 02-Oct-2020 and last participant last visit on 23-Jul-2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eliapixant 25 mg BID | Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks. |
| FG001 | Eliapixant 75 mg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2021 | Jun 18, 2022 |
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| Placebo | Drug | Matching Placebo for BAY1817080 will be administered orally as tablet. |
|
| From baseline up to 12 weeks |
| Change From Baseline in 24-hour Cough Count After 2, 4, and 8 Weeks of Intervention | The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. For the ratio between the geometric means of 24-hour cough count, the geometric mean of 24-hour cough count after 2, 4, and 8 weeks of intervention was divided by the geometric mean of 24-hour cough count at baseline. btw = between geo = geometric | From baseline up to 2 weeks, 4 weeks and 8 weeks |
| Change From Baseline in Awake Cough Frequency Per Hour After 2, 4, 8 and 12 Weeks of Intervention | Measured by cough recording digital wearable monitoring device btw = between geo = geometric | From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks |
| Change From Baseline in Cough Related Quality of Life After 12 Weeks of Intervention | Measured by Leicester Cough Questionnaire (LCQ) total score. The LCQ was a 19-item instrument that asked about the impact of chronic cough on various aspects of participants' lives using a recall period of two weeks. The 8 items: 1, 2, 3, 9, 10, 11, 14, 15 built the physical domain. 7 items: 4, 5, 6, 12, 13, 16, 17 built the psychological domain. Further 4 items: 7, 8, 18 and 19 built the social domain. Study participants responded to the items using a 7-point Likert scale from 1 (all of the time) to 7 (none of the time) and entered their assessments on a tablet device. Completion of the LCQ took approximately five minutes. The LCQ total score was calculated as a mean score for each of the three domains ranging from 1 to 7, with the LCQ total score ranging from 3 to 21. | From baseline up to 12 weeks |
| Change From Baseline in Cough Severity After 12 Weeks of Intervention | Measured by Cough Severity Visual Analogue Scale (VAS). The Cough Severity VAS was a single item instrument, asking the study participant to assess the severity of his/her cough using a 0-100 VAS. This was a vertically oriented line ordered from 0-100, with 0 = "No Cough" and 100 = "Extremely Severe Cough". | From baseline up to 12 weeks |
| Percentage of Participants With a ≥30 Scale Units Reduction From Baseline After 12 Weeks of Intervention | Measured by cough Severity VAS | From baseline up to 12 weeks |
| Percentage of Participants With a ≥1.3-point Increase From Baseline After 12 Weeks of Intervention | Measured by LCQ total score. The LCQ was a 19-item instrument that asked about the impact of chronic cough on various aspects of participants' lives using a recall period of two weeks. The 8 items: 1, 2, 3, 9, 10, 11, 14, 15 built the physical domain. 7 items: 4, 5, 6, 12, 13, 16, 17 built the psychological domain. Further 4 items: 7, 8, 18 and 19 built the social domain. Study participants responded to the items using a 7-point Likert scale from 1 (all of the time) to 7 (none of the time) and entered their assessments on a tablet device. Completion of the LCQ took approximately five minutes. The LCQ total score was calculated as a mean score for each of the three domains ranging from 1 to 7, with the LCQ total score ranging from 3 to 21. The percentage of participants with a >= 1.3-point increase in LCQ total score is shown. | From baseline up to 12 weeks |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity | Adverse event (AE) was defined as any untoward medical occurrence in a study participant, whether or not considered related to the study intervention, occurring from the time of signing the informed consent until the follow-up visit. TEAE was defined as any event occurring or worsening after the start of study intervention administration until 14 days after the last intake of study intervention. | From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days |
| Florida Pediatrics |
| Largo |
| Florida |
| 33778 |
| United States |
| Chesapeake Clinical Research, Inc. | White Marsh | Maryland | 21162 | United States |
| Minnesota Lung Center | Edina | Minnesota | 55435 | United States |
| Montana Medical Research, Inc | Missoula | Montana | 59808 | United States |
| Vanderbilt University Medical School | Nashville | Tennessee | 37212-1610 | United States |
| Pharmaceutical Research & Consulting, Inc. | Dallas | Texas | 75231 | United States |
| Bellingham Asthma, Allergy & Immunology Clinic | Bellingham | Washington | 98225 | United States |
| Instituto Ave Pulmo | Mar del Plata | Buenos Aires | Argentina |
| Centro Respiratorio Quilmes | Quilmes | Buenos Aires | Argentina |
| Centro Médico Dra. De Salvo - Clinical Research Center | Buenos Aires | Ciudad Auton. de Buenos Aires | C1426ABP | Argentina |
| Centro de Investigaciones Clínicas | CABA | Ciudad Auton. de Buenos Aires | C1018DES | Argentina |
| Fundación CIDEA | CABA | Ciudad Auton. de Buenos Aires | C1121ABE | Argentina |
| Investigación en Alergias y Enfermedades Respiratorias-INAER | CABA | Ciudad Auton. de Buenos Aires | C1425 | Argentina |
| Investigaciones en Patologías Respiratorias | San Miguel de Tucumán | Tucumán Province | Argentina |
| Macquarie University Hospital | Macquarie University | New South Wales | 2109 | Australia |
| Maroubra Medical Centre | Maroubra | New South Wales | 2035 | Australia |
| Holdsworth House Medical Practice | Sydney | New South Wales | 2010 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Western Respiratory Trial Specialists | Spearwood | Western Australia | 6163 | Australia |
| Dr. MARTINOT Jean-Benoît | Erpent | 5101 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| VZW Emmaus | Mechelen | 2800 | Belgium |
| Burlington Lung Clinic (BLC) Clinical Research | Burlington | Ontario | L7N 3V2 | Canada |
| Clinique de pneumologie et du sommeil de Lanaudière (CPSL) | Saint-Charles-Borromée | Quebec | J6E 2B4 | Canada |
| MUDr Otakar Hokynar - Plicni ambulance | Kralupy nad Vltavou | 278 01 | Czechia |
| Ordinace pro TBC a respiracni nemoci, s.r.o. | Olomouc | 772 00 | Czechia |
| Dawon s.r.o. | Prague | 14800 | Czechia |
| Plicní stredisko Teplice, s.r.o. | Teplice | 415 01 | Czechia |
| MUDr. Milan Sklenar | Varnsdorf | 407 47 | Czechia |
| Cochin - Paris | Paris | 75674 | France |
| CHU de Toulouse - Hôpital Larrey | Toulouse | 31059 | France |
| Klinikum Konstanz | Konstanz | Baden-Wurttemberg | 78464 | Germany |
| Zentrum f. ambulante pneumologische Forschung Marburg GbR | Marburg | Hesse | 35037 | Germany |
| Ballenberger, Freytag, Wenisch | Neu-Isenburg | Hesse | 63263 | Germany |
| Pneumologicum im Südstadt Forum | Hanover | Lower Saxony | 30173 | Germany |
| Medizinische Hochschule Hannover (MHH) | Hanover | Lower Saxony | 30625 | Germany |
| Priv.-Doz. Dr. med. Christian Gessner | Leipzig | Saxony | 04357 | Germany |
| Praxis f. Lungen- und Bronchialheilkunde, | Berlin | 10717 | Germany |
| D.Kenessey A Hospital | Balassagyarmat | 2660 | Hungary |
| EKBC, Uj Szent Janos Korhaz es Szakrendelo | Budapest | 1122 | Hungary |
| Erzsebet Gondozohaz | Gödöllő | 2100 | Hungary |
| Da Vinci Maganklinika | Pécs | 7635 | Hungary |
| Farmakontroll Bt. | Százhalombatta | 2440 | Hungary |
| ASST Lodi | Lodi | Lombardy | 26845 | Italy |
| A.O.U. Careggi | Florence | Tuscany | 50134 | Italy |
| IRCCS Ospedale Sacro Cuore Don Calabria | Verona | Veneto | 37024 | Italy |
| A.O.U.I. Verona | Verona | Veneto | 37126 | Italy |
| Nagoya City University Hospital | Nagoya | Aichi-ken | 467-8602 | Japan |
| University of Fukui Hospital | Yoshida | Fukui | 910-1193 | Japan |
| University of Occupational and Environmental Health | Kitakyushu | Fukuoka | 807-8556 | Japan |
| Idaimae Minami Yojo | Sapporo | Hokkaido | 064-0804 | Japan |
| Japan community health care organization Kanazawa Hospital | Kanazawa | Ishikawa-ken | 920-8610 | Japan |
| Komatsu Municipal Hospital | Komatsu | Ishikawa-ken | 923-8560 | Japan |
| Yokohama City Minato Red Cross Hospital | Yokohama | Kanagawa | 231-8682 | Japan |
| Saiseikai Yokohamashi Nanbu Hospital | Yokohama | Kanagawa | 234-8503 | Japan |
| Matsusaka Municipal Hospital | Matsusaka | Mie-ken | 515-8544 | Japan |
| Hamamatsu Rosai Hospital | Hamamatsu | Shizuoka | 430-8525 | Japan |
| Tokyo Shinagawa Hospital | Shinagawa-ku | Tokyo | 140-8522 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan |
| Catharina Ziekenhuis | Eindhoven | North Brabant | 5623 EJ | Netherlands |
| Isala | Zwolle | 8025 AB | Netherlands |
| Centrum Medycyny Oddechowej Mroz Spolka Jawna | Bialystok | 15-044 | Poland |
| KLIMED Marek Klimkiewicz | Bychawa | 23-100 | Poland |
| Centrum Alergologii Sp. z o.o. | Lublin | 20-552 | Poland |
| Ostrowieckie Centrum Medyczne Sp. Cyw. A.O-C. K.C. | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Centrum Medyczne Lucyna Andrzej Dymek | Strzelce Opolskie | 47-100 | Poland |
| Region Clinical Emergency Hospital n.a. M.A.Podgorbunskogo | Kemerovo | 650000 | Russia |
| City Clinical Hospital n.a. D.D. Pletnev | Moscow | 105077 | Russia |
| LLC "Medical Center "SibNovoMed"" | Novosibirsk | 630005 | Russia |
| City Consultative and Diagnostic Center #1 | Saint Petersburg | 194354 | Russia |
| LLC Astarta | Saint Petersburg | 199226 | Russia |
| City Clinical Hospital #4 Samara | Samara | 453056 | Russia |
| Voronezh Regional Clinical Hospital #1 | Voronezh | 394066 | Russia |
| ALIAN s.r.o. | Bardejov | 085 01 | Slovakia |
| INSPIRO, s.r.o. | Humenné | 066 01 | Slovakia |
| AlergoImunocentrum, s.r.o. | Kežmarok | 060 01 | Slovakia |
| Plucna ambulancia s.r.o. | Poprad | 058 01 | Slovakia |
| Ambulancia klin. imunologie a alergologie, ANA JJ, s.r.o. | Topoľčany | 955 01 | Slovakia |
| Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | A Coruña | 15706 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Clínic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Chang Gung Memorial Hospital Keelung | Keelung | 20401 | Taiwan |
| Far Eastern Memorial Hospital | New Taipei City | 220 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Medical University Hospital | Taipei | 110 | Taiwan |
| Akdeniz Universitesi Tip Fakultesi Hastanesi | Antalya | 07058 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi | Istanbul | 34098 | Turkey (Türkiye) |
| Ege Universitesi Tip Fakultesi | Izmir | 35100 | Turkey (Türkiye) |
| Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH | Maltepe | 34844 | Turkey (Türkiye) |
| Mersin Universitesi Tip Fakultesi | Mersin | 33343 | Turkey (Türkiye) |
| North Tyneside General Hospital | North Shields | Tyne and Wear | NE29 8NH | United Kingdom |
| West Walk Surgery | Bristol | BS37 4AX | United Kingdom |
| Castle Hill Hospital | Cottingham | HU16 5JQ | United Kingdom |
| King's College Hospital - NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| University Hospital of South Manchester | Manchester | M23 9LT | United Kingdom |
| 37261531 | Derived | Dicpinigaitis PV, Morice AH, Smith JA, Sher MR, Vaezi M, Guilleminault L, Niimi A, Gude K, Krahn U, Saarinen R, Pires PV, Wosnitza M, McGarvey L; PAGANINI Investigators. Efficacy and Safety of Eliapixant in Refractory Chronic Cough: The Randomized, Placebo-Controlled Phase 2b PAGANINI Study. Lung. 2023 Jun;201(3):255-266. doi: 10.1007/s00408-023-00621-x. Epub 2023 Jun 1. |
Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks.
| FG002 | Eliapixant 150 mg BID | Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks. |
| FG003 | Placebo | Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Eliapixant 25 mg BID | Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks. |
| BG001 | Eliapixant 75 mg BID | Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks. |
| BG002 | Eliapixant 150 mg BID | Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks. |
| BG003 | Placebo | Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Used full analysis set: All participants randomly assigned to study intervention. | Mean | Standard Deviation | years |
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| Age, Customized | Used full analysis set | Number | Participants |
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| Sex: Female, Male | Used full analysis set | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Used full analysis set | Count of Participants | Participants |
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| Baseline 24-hour coughs per hour | Used per protocol set (PPS): All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants, 4.8%) or that the participant had used prohibited concomitant medication (9 participants, 2.9%). | Used per protocol set (PPS) | Geometric Mean | Standard Deviation | 24-hour cough count per hour |
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| Baseline Leicester Cough Questionnaire (LCQ) Total Score | The LCQ was a 19-item instrument that asked about the impact of chronic cough on various aspects of participants' lives. 8 items built the physical domain. 7 items built the psychological domain. 4 items built the social domain. Study participants responded to the items using a 7-point Likert scale from 1 (all of the time) to 7 (none of the time) and entered their assessments on a tablet device. The LCQ total score was calculated as a mean score for each of the three domains ranging from 1 to 7, with the LCQ total score ranging from 3 to 21. | Used per protocol set (PPS) | Mean | Standard Deviation | Scores on a scale |
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| Baseline awake cough count per hour | Used per protocol set (PPS) | Geometric Mean | Standard Deviation | Cough count per hour |
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| Baseline Cough Severity Visual Analogue Scale [VAS] Value | The Cough Severity VAS was a single item instrument, asking the study participant to assess the severity of his/her cough using a 0-100 VAS. This was a vertically oriented line ordered from 0-100, with 0 = "No Cough" and 100 = "Extremely Severe Cough". | Used per protocol set (PPS) - Included the participants in PPS with valid VAS value. | Mean | Standard Deviation | Scores on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in 24-hour Cough Count After 12 Weeks of Intervention | The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. For the ratio between the geometric means of 24-hour cough count, the geometric mean of 24-hour cough count after 12 weeks of intervention was divided by the geometric mean of 24-hour cough count at baseline. btw = between geo = geometric | All participants in PPS with valid 24-hour cough count values in Week 12 or Termination visit. | Posted | Geometric Mean | Standard Deviation | Ratio btw geoMeans of 24h cough count | From baseline up to 12 weeks |
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| Secondary | Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Cough Count After 12 Weeks of Intervention | The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. The change from baseline in 24-hour cough count was calculated by the geometric mean of 24-hour cough count after 12 weeks of intervention minus the geometric mean at baseline divided by the geometric mean at baseline. The percentage of participants with a reduction of ≥30% is shown | PPS | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline up to 12 weeks |
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| Secondary | Change From Baseline in 24-hour Cough Count After 2, 4, and 8 Weeks of Intervention | The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. For the ratio between the geometric means of 24-hour cough count, the geometric mean of 24-hour cough count after 2, 4, and 8 weeks of intervention was divided by the geometric mean of 24-hour cough count at baseline. btw = between geo = geometric | PPS | Posted | Geometric Mean | Standard Deviation | Ratio btw geoMeans of 24h cough count | From baseline up to 2 weeks, 4 weeks and 8 weeks |
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| Secondary | Change From Baseline in Awake Cough Frequency Per Hour After 2, 4, 8 and 12 Weeks of Intervention | Measured by cough recording digital wearable monitoring device btw = between geo = geometric | PPS | Posted | Geometric Mean | Standard Deviation | Ratio btw geoMeans of 24h cough count | From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks |
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| Secondary | Change From Baseline in Cough Related Quality of Life After 12 Weeks of Intervention | Measured by Leicester Cough Questionnaire (LCQ) total score. The LCQ was a 19-item instrument that asked about the impact of chronic cough on various aspects of participants' lives using a recall period of two weeks. The 8 items: 1, 2, 3, 9, 10, 11, 14, 15 built the physical domain. 7 items: 4, 5, 6, 12, 13, 16, 17 built the psychological domain. Further 4 items: 7, 8, 18 and 19 built the social domain. Study participants responded to the items using a 7-point Likert scale from 1 (all of the time) to 7 (none of the time) and entered their assessments on a tablet device. Completion of the LCQ took approximately five minutes. The LCQ total score was calculated as a mean score for each of the three domains ranging from 1 to 7, with the LCQ total score ranging from 3 to 21. | All participants in PPS with valid Leicester Cough Questionnaire scores in Week 12 or Termination visit were included. | Posted | Mean | Standard Deviation | Scores on a scale | From baseline up to 12 weeks |
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| Secondary | Change From Baseline in Cough Severity After 12 Weeks of Intervention | Measured by Cough Severity Visual Analogue Scale (VAS). The Cough Severity VAS was a single item instrument, asking the study participant to assess the severity of his/her cough using a 0-100 VAS. This was a vertically oriented line ordered from 0-100, with 0 = "No Cough" and 100 = "Extremely Severe Cough". | All participants in PPS with valid VAS scores in Week 12 or Termination visit. | Posted | Mean | Standard Deviation | Scores on a scale | From baseline up to 12 weeks |
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| Secondary | Percentage of Participants With a ≥30 Scale Units Reduction From Baseline After 12 Weeks of Intervention | Measured by cough Severity VAS | PPS | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline up to 12 weeks |
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| Secondary | Percentage of Participants With a ≥1.3-point Increase From Baseline After 12 Weeks of Intervention | Measured by LCQ total score. The LCQ was a 19-item instrument that asked about the impact of chronic cough on various aspects of participants' lives using a recall period of two weeks. The 8 items: 1, 2, 3, 9, 10, 11, 14, 15 built the physical domain. 7 items: 4, 5, 6, 12, 13, 16, 17 built the psychological domain. Further 4 items: 7, 8, 18 and 19 built the social domain. Study participants responded to the items using a 7-point Likert scale from 1 (all of the time) to 7 (none of the time) and entered their assessments on a tablet device. Completion of the LCQ took approximately five minutes. The LCQ total score was calculated as a mean score for each of the three domains ranging from 1 to 7, with the LCQ total score ranging from 3 to 21. The percentage of participants with a >= 1.3-point increase in LCQ total score is shown. | PPS | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline up to 12 weeks |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity | Adverse event (AE) was defined as any untoward medical occurrence in a study participant, whether or not considered related to the study intervention, occurring from the time of signing the informed consent until the follow-up visit. TEAE was defined as any event occurring or worsening after the start of study intervention administration until 14 days after the last intake of study intervention. | Safety analysis set (SAF): All participants randomly assigned to study intervention and who took at least one tablet of study intervention. Participants were analyzed according to the intervention they actually received. | Posted | Count of Participants | Participants | From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days |
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From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 80.0 + 30 ± 5 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eliapixant 25 mg BID | Participants were randomized to receive 25 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks. | 0 | 75 | 0 | 75 | 32 | 75 |
| EG001 | Eliapixant 75 mg BID | Participants were randomized to receive 75 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks. | 0 | 78 | 1 | 78 | 37 | 78 |
| EG002 | Eliapixant 150 mg BID | Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks. | 0 | 80 | 2 | 80 | 45 | 80 |
| EG003 | Placebo | Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks. | 0 | 77 | 1 | 77 | 25 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Non-systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA (24.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Swelling face | General disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (24.0) | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (24.0) | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (24.0) | Non-systematic Assessment |
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| Blood fibrinogen increased | Investigations | MedDRA (24.0) | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA (24.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Ageusia | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Hypogeusia | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Taste disorder | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer AG | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2021 | Jun 18, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| From 65-84 years |
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| Detection of dose-response: Emax model (ED50=50) Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided). | MCP-Mod method | = 0.0376 | Adjusted p-value | Superiority |
| Detection of dose-response: sigm. Emax model (ED50=30, h=3) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided). | MCP-Mod method | = 0.0319 | Adjusted p-value | Superiority |
| Detection of dose-response: sigm. Emax model (ED50=60, h=5) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided). | MCP-Mod method | = 0.0603 | Adjusted p-value | Superiority |
| OG003 |
| Placebo |
Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks. |
|
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| Placebo |
Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks. |
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| OG002 | Eliapixant 150 mg BID | Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks. |
| OG003 | Placebo | Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks. |
|
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Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks. |
|
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| Units | Counts |
|---|---|
| Participants |
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| OG002 |
| Eliapixant 150 mg BID |
Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks. |
| OG003 | Placebo | Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks. |
|
|
Participants were randomized to receive 150 mg oral doses of eliapixant, administered twice daily over the course of 12 weeks. |
| OG003 | Placebo | Participants were randomized to receive placebo for eliapixant, administered twice daily over the course of 12 weeks. |
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