Mepolizumab for the Treatment of Chronic Cough With Eosinophilic Airways Diseases
NCT ID: NCT04765722
Last Updated: 2025-09-16
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
46 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-12-14
Study Completion Date
2024-11-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Cough is the most common presenting symptom to family physician. Chronic Cough affects approximately 10-12% of the general population and is one of the commonest reasons for referral to secondary care. Unfortunately, there are no licensed treatments for this debilitating condition, which is associated with a poor quality of life, affecting the social, physical and psychological well-being of patients.
The aim of this single-centre proof-of-concept study is to investigate whether mepolizumab reduces objective cough frequency in patients with eosinophilic asthma and non-asthmatic eosinophilic bronchitis presenting with chronic cough. Secondary outcomes including the effects on quality of life, the intensity of irritant sensations, airway hyper-reactivity and inflammatory cells and their progenitors will also be evaluated.
The investigators hypothesize that in patients with asthma and non-asthmatic eosinophilic bronchitis, eosinophils are involved in sensitizing airway nerves and thereby increasing spontaneous objective coughs. The investigators predict that treatment with mepolizumab will reduce airway eosinophilia in patients with chronic cough due to eosinophilic asthma and non-asthmatic eosinophilic bronchitis, thereby causing a reduction in objective cough frequency.
The aim of this single-centre proof-of-concept study is to investigate whether mepolizumab reduces objective cough frequency in patients with eosinophilic asthma and non-asthmatic eosinophilic bronchitis presenting with chronic cough. Secondary outcomes including the effects on quality of life, the intensity of irritant sensations, airway hyper-reactivity and inflammatory cells and their progenitors will also be evaluated.
The investigators hypothesize that in patients with asthma and non-asthmatic eosinophilic bronchitis, eosinophils are involved in sensitizing airway nerves and thereby increasing spontaneous objective coughs. The investigators predict that treatment with mepolizumab will reduce airway eosinophilia in patients with chronic cough due to eosinophilic asthma and non-asthmatic eosinophilic bronchitis, thereby causing a reduction in objective cough frequency.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma
NCT03562195
Asthma
COMPLETED
PHASE3
Effect of Mepolizumab on Decrease of Systemic Corticosteroids in Patients With Severe Eosinophilic Asthma
NCT03453021
Asthma; Eosinophilic
COMPLETED
Symptoms Control and adhErenCe Assessment During Treatment With MepolizUmab New pREfilled Devices
NCT05626777
Asthma
ACTIVE_NOT_RECRUITING
PHASE4
Effect of Mepolizumab on Severe Eosinophilic Asthma
NCT04641741
Asthma
Eosinophilic Asthma
UNKNOWN
Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab".
NCT04585997
Asthma
Eosinophilic Asthma
UNKNOWN
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a 9-visit randomized, double-blind, placebo-controlled, parallel-group Phase IV study. The purpose of this study is to evaluate the effectiveness of mepolizumab for the treatment of refractory chronic cough in patients with eosinophilic airway disease. Patients will be recruited from secondary care clinics. Patient eligibility will be assessed against the study inclusion/exclusion criteria and patients will undergo informed consent in the research centre. Subjects who provide informed consent and are enrolled in the study will undergo screening procedures.
The study will consist of a Mepolizumab treatment arm and placebo arm (normal saline). Fifteen subjects will be randomly assigned to the treatment arm and fifteen subjects will be randomly assigned to the placebo arm in a 1:1 ratio. Following screening and randomization, subjects will under an 12-week treatment period during which they will receive 4 doses of the study drug at days 0, 28, 56, and 84. The primary study outcomes will be measured at week 14 week, 2 weeks following the treatment period.
At Visit 1 (screening), subjects will undergo screening procedures: complete medical history, physical examination, methacholine challenge, spirometry, sputum induction, and blood sampling. Subjects will complete the Leicester Cough Questionnaire and modified Borg Scale.
At Visit 2, subjects will be fitted with a 24-hour cough monitor.
At Visit 3, 24-hour cough monitors will be removed and subjects will undergo spirometry, blood sampling and sputum induction. Subjects will complete the Leicester Cough Questionnaire, modified Borg Scale, and Cough Severity Visual Analogue Scale. The first dose of the study drug will be administered in the clinical research facility by a study physician.
At Visit 4, subjects will undergo spirometry and blood sampling and complete the Leicester Cough Questionnaire, modified Borg Scale, and Cough Severity Visual Analogue Scale. The second dose of the study drug will be administered in the clinical research facility by a study physician.
At Visit 5, the third dose of the study drug will be administered in the clinical research facility by a study physician. Subjects will be fitted with a 24-hour cough monitor.
At Visit 6, 24-hour cough monitors will be removed and subjects will undergo spirometry, sputum induction and blood sampling and complete the Leicester Cough Questionnaire, modified Borg Scale, and Cough Severity Visual Analogue Scale.
At Visit 7, subjects will undergo spirometry and blood sampling and complete the Leicester Cough Questionnaire, modified Borg Scale, and Cough Severity Visual Analogue Scale. The fourth dose of the study drug will be administered in the clinical research facility by a study physician.
At Visit 8, subjects will be fitted with a 24-hour cough monitor.
At Visit 9, the 24-hour cough monitors will be removed and subjects will undergo spirometry, methacholine challenge, sputum induction, and blood sampling. Subjects will complete the Leicester Cough Questionnaire, modified Borg Scale, and Cough Severity Visual Analogue Scale.
All study procedures will be performed according to local standard operating procedures and be conducted by trained and experienced staff with supervision by medical doctors. Study physicians will administer all study drug injections. Safety will be assessed throughout the study by monitoring for adverse events and serious adverse events.
The study will consist of a Mepolizumab treatment arm and placebo arm (normal saline). Fifteen subjects will be randomly assigned to the treatment arm and fifteen subjects will be randomly assigned to the placebo arm in a 1:1 ratio. Following screening and randomization, subjects will under an 12-week treatment period during which they will receive 4 doses of the study drug at days 0, 28, 56, and 84. The primary study outcomes will be measured at week 14 week, 2 weeks following the treatment period.
At Visit 1 (screening), subjects will undergo screening procedures: complete medical history, physical examination, methacholine challenge, spirometry, sputum induction, and blood sampling. Subjects will complete the Leicester Cough Questionnaire and modified Borg Scale.
At Visit 2, subjects will be fitted with a 24-hour cough monitor.
At Visit 3, 24-hour cough monitors will be removed and subjects will undergo spirometry, blood sampling and sputum induction. Subjects will complete the Leicester Cough Questionnaire, modified Borg Scale, and Cough Severity Visual Analogue Scale. The first dose of the study drug will be administered in the clinical research facility by a study physician.
At Visit 4, subjects will undergo spirometry and blood sampling and complete the Leicester Cough Questionnaire, modified Borg Scale, and Cough Severity Visual Analogue Scale. The second dose of the study drug will be administered in the clinical research facility by a study physician.
At Visit 5, the third dose of the study drug will be administered in the clinical research facility by a study physician. Subjects will be fitted with a 24-hour cough monitor.
At Visit 6, 24-hour cough monitors will be removed and subjects will undergo spirometry, sputum induction and blood sampling and complete the Leicester Cough Questionnaire, modified Borg Scale, and Cough Severity Visual Analogue Scale.
At Visit 7, subjects will undergo spirometry and blood sampling and complete the Leicester Cough Questionnaire, modified Borg Scale, and Cough Severity Visual Analogue Scale. The fourth dose of the study drug will be administered in the clinical research facility by a study physician.
At Visit 8, subjects will be fitted with a 24-hour cough monitor.
At Visit 9, the 24-hour cough monitors will be removed and subjects will undergo spirometry, methacholine challenge, sputum induction, and blood sampling. Subjects will complete the Leicester Cough Questionnaire, modified Borg Scale, and Cough Severity Visual Analogue Scale.
All study procedures will be performed according to local standard operating procedures and be conducted by trained and experienced staff with supervision by medical doctors. Study physicians will administer all study drug injections. Safety will be assessed throughout the study by monitoring for adverse events and serious adverse events.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Chronic Cough
Eosinophilic Bronchitis
Asthma
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Single-centre, randomized, double-blind, placebo-controlled, parallel-group proof-of-concept study to evaluate the effectiveness of 4 doses of mepolizumab for the treatment of refractory chronic cough in patients with asthma and non-asthmatic eosinophilic bronchitis. The study will have 2 arms, each with 15 participants, and a total of 9 visits per subject. Subjects will be screened and within 2 weeks randomized to the intervention (mepolizumab) or placebo arm. Subjects will receive the intervention over a 12 week period at visits 3, 4, 5, and 7. The primary outcome will be measured at visit 14 which will occur 2 weeks after the final intervention dose.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Subjects will be assigned to one of the two possible treatment arms generated by a computer-generated randomization schedule prepared by McMaster University, with a ratio of 1:1, mepolizumab or placebo. As there is a known imbalance in the prevalence and cough rates, the study will include sex as a randomization factor. This will mitigate the possibility of the intervention being confounded by sex differences in the 2 arms of the study. Blinded study drug supplies will be provided in sequentially numbered identical syringes in accordance with the randomization schedule and dispensed by a pharmacist who shall not be delegated any other role in the study. Subjects, investigators, research staff (with the exception of the pharmacist) and the sponsor will be masked to the treatment sequence assignment. A sealed code-break envelope for each subject containing details of the treatment allocated will be kept in a locked safe at the study site.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mepolizumab arm
Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks
Group Type
EXPERIMENTAL
Mepolizumab
Intervention Type
DRUG
Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Placebo arm
Normal Saline (0.09% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks
Group Type
PLACEBO_COMPARATOR
Normal Saline
Intervention Type
DRUG
Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mepolizumab
Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Intervention Type
DRUG
Normal Saline
Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Nucala
0.09% normal saline
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Aged ≥18
2. Subjects with a history of chronic cough (cough lasting for \>8 weeks)
3. Evidence of airway eosinophilia (sputum eosinophilia\>2%)
4. Forced expiratory volume-1 ≥ 70% of predicted
5. Normal chest x-ray (within the last 6 months)
6. At least one dose of a COVID-19 vaccine a minimum of 2 weeks prior to enrollment
2. Subjects with a history of chronic cough (cough lasting for \>8 weeks)
3. Evidence of airway eosinophilia (sputum eosinophilia\>2%)
4. Forced expiratory volume-1 ≥ 70% of predicted
5. Normal chest x-ray (within the last 6 months)
6. At least one dose of a COVID-19 vaccine a minimum of 2 weeks prior to enrollment
Exclusion Criteria
1. Symptoms of upper respiratory tract infection in the last 1 month which have not resolved.
2. Lower respiratory tract infection or pneumonia in the last 1 month.
3. Subjects with a positive covid-19 test within 2 weeks of screening
4. Subjects with seasonal allergic rhinitis that affects their asthma control
5. Current smoker or ex-smoker with ≥10 pack year smoking history and abstinence of ≤6 months
6. Symptoms of uncontrolled asthma at screening defined as: Asthma Control Questionnaire-5 \>1.5, or use of 3 or more puffs of a short acting beta-2 agonist per week, or an exacerbation in the previous month requiring oral prednisone or antibiotics.
7. Use of regular maintenance oral corticosteroids or long-acting muscarinic antagonist within 4 weeks prior to enrolment into the study.
8. A previous asthma exacerbation requiring Intensive Care Unit admission.
9. Significant other primary pulmonary disorders in particular; pulmonary embolism, pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis, emphysema or bronchiectasis.
10. Any history or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias, hypertension, or congestive heart failure.
11. Any history or symptoms of significant neurologic disease, including transient ischemic attack, stroke, seizure disorder, or behavioural disturbances
12. Uncontrolled diabetes
13. End-stage kidney or liver disease
14. Clinically significant abnormalities in laboratory test results during the screening period (including complete blood count, coagulation, electrolytes, liver function tests) unless deemed not significant by the investigator.
15. Any history or symptoms of clinically significant autoimmune disease
16. History of anaphylaxis to any biologic therapy or vaccine
17. History of Guillain-Barre Syndrome
18. A helminth parasitic infection diagnosed within 24 weeks prior to the date of informed consent is obtained that has not been treated with or has failed to respond to standard of care therapy.
19. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B can enroll.
20. A history of immunodeficiency disorders including a positive human immunodeficiency virus test
21. Pregnancy or breast-feeding.
22. Women of childbearing potential must not be actively seeking pregnancy, and must use an effective form of birth control (confirmed by the Investigator). Effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device/ intrauterine system levonorgestrel Intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch™ or Nuvaring™. Women of childbearing potential must agree to use an effective method of birth control, as defined above, from enrolment, throughout the study duration and within the 8 treatment weeks. They must demonstrate a negative serum pregnancy test at screening and demonstrate a negative urine pregnancy test immediately before each dose of study drug or placebo. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply:
i. Women \<50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.
ii. Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
23. Male patients not using an acceptable method of contraception. All male patients who are sexually active must agree to use an acceptable method of contraception (condom with or without spermicide, vasectomy) from the first dose of study drug until their last dose.
24. Use of angiotensin-converting-enzyme inhibitors
25. Use of immunosuppressive medication (including but not limited to: methotrexate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, oral corticosteroid, or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent is obtained
26. Use of any other biological within 4 months or 5 half-lives prior to randomization, whichever is longer.
27. Any centrally acting medication within the last 2 weeks which in the view of the investigator could influence the coughing (Any participant who is taking amitriptyline, dextromethorphan, pregabalin, gabapentin or opioids will not be eligible to take part in this study unless they are willing and medically able to withdraw from such medication for the duration of the study. The reason for this is that centrally acting medications may influence coughing rates.)
28. History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
2. Lower respiratory tract infection or pneumonia in the last 1 month.
3. Subjects with a positive covid-19 test within 2 weeks of screening
4. Subjects with seasonal allergic rhinitis that affects their asthma control
5. Current smoker or ex-smoker with ≥10 pack year smoking history and abstinence of ≤6 months
6. Symptoms of uncontrolled asthma at screening defined as: Asthma Control Questionnaire-5 \>1.5, or use of 3 or more puffs of a short acting beta-2 agonist per week, or an exacerbation in the previous month requiring oral prednisone or antibiotics.
7. Use of regular maintenance oral corticosteroids or long-acting muscarinic antagonist within 4 weeks prior to enrolment into the study.
8. A previous asthma exacerbation requiring Intensive Care Unit admission.
9. Significant other primary pulmonary disorders in particular; pulmonary embolism, pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis, emphysema or bronchiectasis.
10. Any history or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias, hypertension, or congestive heart failure.
11. Any history or symptoms of significant neurologic disease, including transient ischemic attack, stroke, seizure disorder, or behavioural disturbances
12. Uncontrolled diabetes
13. End-stage kidney or liver disease
14. Clinically significant abnormalities in laboratory test results during the screening period (including complete blood count, coagulation, electrolytes, liver function tests) unless deemed not significant by the investigator.
15. Any history or symptoms of clinically significant autoimmune disease
16. History of anaphylaxis to any biologic therapy or vaccine
17. History of Guillain-Barre Syndrome
18. A helminth parasitic infection diagnosed within 24 weeks prior to the date of informed consent is obtained that has not been treated with or has failed to respond to standard of care therapy.
19. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B can enroll.
20. A history of immunodeficiency disorders including a positive human immunodeficiency virus test
21. Pregnancy or breast-feeding.
22. Women of childbearing potential must not be actively seeking pregnancy, and must use an effective form of birth control (confirmed by the Investigator). Effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device/ intrauterine system levonorgestrel Intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch™ or Nuvaring™. Women of childbearing potential must agree to use an effective method of birth control, as defined above, from enrolment, throughout the study duration and within the 8 treatment weeks. They must demonstrate a negative serum pregnancy test at screening and demonstrate a negative urine pregnancy test immediately before each dose of study drug or placebo. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply:
i. Women \<50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.
ii. Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
23. Male patients not using an acceptable method of contraception. All male patients who are sexually active must agree to use an acceptable method of contraception (condom with or without spermicide, vasectomy) from the first dose of study drug until their last dose.
24. Use of angiotensin-converting-enzyme inhibitors
25. Use of immunosuppressive medication (including but not limited to: methotrexate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, oral corticosteroid, or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent is obtained
26. Use of any other biological within 4 months or 5 half-lives prior to randomization, whichever is longer.
27. Any centrally acting medication within the last 2 weeks which in the view of the investigator could influence the coughing (Any participant who is taking amitriptyline, dextromethorphan, pregabalin, gabapentin or opioids will not be eligible to take part in this study unless they are willing and medically able to withdraw from such medication for the duration of the study. The reason for this is that centrally acting medications may influence coughing rates.)
28. History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Manchester
OTHER
Sponsor Role
collaborator
McMaster University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Imran Satia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McMaster University
Hamilton, Ontario, Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Canada
References
Explore related publications, articles, or registry entries linked to this study.
Schappert SM, Burt CW. Ambulatory care visits to physician offices, hospital outpatient departments, and emergency departments: United States, 2001-02. Vital Health Stat 13. 2006 Feb;(159):1-66.
Reference Type
BACKGROUND
Song WJ, Chang YS, Faruqi S, Kim JY, Kang MG, Kim S, Jo EJ, Kim MH, Plevkova J, Park HW, Cho SH, Morice AH. The global epidemiology of chronic cough in adults: a systematic review and meta-analysis. Eur Respir J. 2015 May;45(5):1479-81. doi: 10.1183/09031936.00218714. Epub 2015 Feb 5. No abstract available.
Reference Type
BACKGROUND
Irwin RS, Baumann MH, Bolser DC, Boulet LP, Braman SS, Brightling CE, Brown KK, Canning BJ, Chang AB, Dicpinigaitis PV, Eccles R, Glomb WB, Goldstein LB, Graham LM, Hargreave FE, Kvale PA, Lewis SZ, McCool FD, McCrory DC, Prakash UBS, Pratter MR, Rosen MJ, Schulman E, Shannon JJ, Hammond CS, Tarlo SM. Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):1S-23S. doi: 10.1378/chest.129.1_suppl.1S. No abstract available.
Reference Type
BACKGROUND
French CL, Irwin RS, Curley FJ, Krikorian CJ. Impact of chronic cough on quality of life. Arch Intern Med. 1998 Aug 10-24;158(15):1657-61. doi: 10.1001/archinte.158.15.1657.
Reference Type
BACKGROUND
Brightling CE, Ward R, Goh KL, Wardlaw AJ, Pavord ID. Eosinophilic bronchitis is an important cause of chronic cough. Am J Respir Crit Care Med. 1999 Aug;160(2):406-10. doi: 10.1164/ajrccm.160.2.9810100.
Reference Type
BACKGROUND
Gibson PG, Dolovich J, Denburg J, Ramsdale EH, Hargreave FE. Chronic cough: eosinophilic bronchitis without asthma. Lancet. 1989 Jun 17;1(8651):1346-8. doi: 10.1016/s0140-6736(89)92801-8.
Reference Type
BACKGROUND
Carney IK, Gibson PG, Murree-Allen K, Saltos N, Olson LG, Hensley MJ. A systematic evaluation of mechanisms in chronic cough. Am J Respir Crit Care Med. 1997 Jul;156(1):211-6. doi: 10.1164/ajrccm.156.1.9605044.
Reference Type
BACKGROUND
Satia I, Watson R, Scime T, Dockry RJ, Sen S, Ford JW, Mitchell PD, Fowler SJ, Gauvreau GM, O'Byrne PM, Smith JA. Allergen challenge increases capsaicin-evoked cough responses in patients with allergic asthma. J Allergy Clin Immunol. 2019 Sep;144(3):788-795.e1. doi: 10.1016/j.jaci.2018.11.050. Epub 2019 Jan 17.
Reference Type
BACKGROUND
Drake MG, Scott GD, Blum ED, Lebold KM, Nie Z, Lee JJ, Fryer AD, Costello RW, Jacoby DB. Eosinophils increase airway sensory nerve density in mice and in human asthma. Sci Transl Med. 2018 Sep 5;10(457):eaar8477. doi: 10.1126/scitranslmed.aar8477.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISS-21-4463
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Montelukast for Persistent Cough in Young People and Adults
NCT01279668
UNKNOWN
PHASE4
Impulse Oscillometry Measurements in Severe Eosinophilic Asthmatics Before and After Anti-IL-5 Factor Initiation
NCT05147155
COMPLETED
Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma
NCT01000506
COMPLETED
PHASE2
Effectiveness of Anti-IL-5/IL5R Inhibitors
NCT06239441
COMPLETED
Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma
NCT01691521
COMPLETED
PHASE3
Mepolizumab Effectiveness in Severe Eosinophilic Asthma and Bronchiectasis
NCT05189613
UNKNOWN
NA
Tezepelumab and Methacholine Airway Hyperresponsiveness in Participants With Mild Allergic Asthma
NCT05740748
UNKNOWN
PHASE2
A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects
NCT01842607
COMPLETED
PHASE3
Efficacy of Mepolizumab in Severe Asthmatics on a Long Term (MESILICO)
NCT04612556
ACTIVE_NOT_RECRUITING
Evaluation of Volatile Organic Compounds in Mepolizumab Therapy
NCT04924478
UNKNOWN
A Study to Evaluate the Safety, Tolerability and Effects of MEDI-563 in Adults With Asthma
NCT00659659
COMPLETED
PHASE1
Mepolizumab Steroid-Sparing Study in Subjects With Severe Refractory Asthma
NCT01691508
COMPLETED
PHASE3
Response and Remission to Treatment With Anti-IL5/IL5R Antagonists
NCT06348173
COMPLETED
A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma
NCT00590720
TERMINATED
PHASE2
Mepolizumab and Physical Activity in Severe Asthma
NCT05404763
RECRUITING
Mepolizumab Treatment for Rhinovirus-induced Asthma Exacerbations
NCT01520051
UNKNOWN
PHASE3
Immunologic Basis of Anti-IgE Therapy (Study II: On Patients With Asthma)
NCT00367016
COMPLETED
PHASE4
MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects
NCT01691859
COMPLETED
PHASE3
Tezepelumab on Airway Structure and Function in Patients With Uncontrolled Moderate-to-severe Asthma
NCT05280418
COMPLETED
PHASE3
Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
NCT00624702
COMPLETED
PHASE1
Safety and Efficacy Study of Eculizumab in Patients With Mild Allergic Asthma
NCT00485576
COMPLETED
PHASE2
Residual Exacerbations With Mepolizumab
NCT04578171
RECRUITING
Exploring Asthma Exacerbations in Mepolizumab Treated Patients
NCT03324230
COMPLETED
A Study on the Effect of Mepolizumab Therapy on Daily Physical Activity of Patients With Severe Eosinophilic Asthma
NCT03739320
UNKNOWN
Optimal Type of Inhaler in Cough Variant- or Cough Predominant Asthma
NCT04203472
COMPLETED
NA