REACH Study

JRCT ID: jRCTs041220003

Registered date:14/04/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: asthma
• Date of first enrollment: 12/10/2022
• Target sample size: 212
• Study type: Interventional

Intervention(s)

Enerzair group (IND/GLY/MF)
: Subjects will inhale medium-dose capsule of ENERZAIR (150 microgram of indacaterol, 50 microgram of glycopyrronium, and 80 microgram of mometasone furan carboxylate ester) once daily for 8 weeks from Visit 1 to Visit 3 using an inhalation device designed specifically for this drug.
Control group (1) (FF/VI)
Subjects will receive an inhaled dose of LELVEA 200 Ellipta (25 microgram of vilanterol and 200 microgram of fluticasone furan carboxylate) once daily for 8 weeks from Visit 1 to Visit 3.
Control group (2) (BUD/FM)
Subjects will receive four inhalations of BUD/FM (Total 8 inhalations: 1280 microgram as budesonide and 36 microgram as formoterol fumarate hydrate) twice daily for eight weeks from Visit 1 to Visit 3. (However, the dosage may be reduced to three inhalations twice daily only if there is a safety concern associated with an increase in the dosage of formoterol fumarate hydrate.)

Outcome(s)

• Primary Outcome: Change from baseline at 8 weeks in J-LCQ

Secondary Outcome

[Important secondary endpoints]
Change from baseline in cough VAS ( awake ) assessment at 8 weeks

[Other secondary endpoints]
1. J-LCQ
:Change from baseline at 4 weeks of treatment
:Percentage of patients achieving a minimum clinically important difference (MCID) of 1.3 or greater from baseline at 4 and 8 weeks.
2. Cough VAS assessment (awake and asleep)
:Change from baseline at 4 weeks of treatment
:Change from baseline at 4 and 8 weeks of treatment
:Percentage of patients who achieve a cough VAS improvement of at least 15 mm from baseline and a cough VAS of less than 40 mm at 4 or 8 weeks of treatment
3. Capsaicin cough receptor sensitivity test
:Change in cough receptor sensitivity from baseline to 8 weeks of treatment
4. VitaloJAK cough monitor
:Change in cough frequency from baseline to 8 weeks of treatment
:Cough frequency in 24 hours (frequency per hour)
:Change in cough frequency (frequency per hour) during waking hours (from 6:00 AM to 10:00 PM)
:Change in cough frequency (frequency per hour) during sleeping hours (from 10 PM to 6 AM the next day)

5. Respiratory function (spirometry)
:Change in respiratory function (FEV1, FVC) from baseline at 8 weeks of treatment
:Change in FEF25-75 (effort expiratory flow rate during exhalation of 25-75% of FVC) from baseline at 8 weeks of treatment
6. Exhaled nitric oxide concentration (FeNO)
:Change from baseline at 8 weeks of treatment
7. Biomarkers (blood eosinophils, blood neutrophils)
:Change from baseline at 4 weeks and 8 weeks of treatment
8. ACQ-6
:Change from baseline at 4 weeks and 8 weeks of treatment
9. CASA-Q
:Change from baseline at 4 weeks and 8 weeks of treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1. Patients whose written consent has been obtained prior to the initiation of any procedure related to this study.
2. Male or female, between 20 and 80 years of age at the time of consent.
3. Patients must have a diagnosis record of asthma at least 3 months prior to Visit 0.
4. Patients who have been receiving moderate doses of FF/VI or BUD/FM for at least one month prior to Visit 0.
5. Patients with a cough VAS (awake) of 40 mm or greater at both Visit 0 and Visit 1 (or Visit 1 pre).
6. Patients who are willing to not receive SMART therapy during the study period.

Exclude criteria

1. Patients who have smoked (including e-cigarettes) within 12 months prior to Visit 0, or who have smoked at least 10 pack-years in the past (Note: 1 pack is equivalent to 20 cigarettes. 10 pack-year = 1 pack/day x 10 years, or 1/2 pack/day x 20 years).
2. Patients who quit smoking within 6 months prior to Visit 0.
3. Patients who have used central antitussives within 1 months prior to Visit 0. (e.g Codeine phosphate, etc.)
4. Patients who have used antitussive herbal medicines within 1 months prior to Visit 0.
5. Patients who have used amitriptyline for neuropathic pain treatment or antitussive purposes within 3 months prior to Visit 0. (Examples opioids, gabapentin, pregabalin, etc.)
6. Patients who have used ACE inhibitors within 3 months prior to Visit 0.
7. Patients who have used anticholinergic drugs (LAMA, SAMA, oral drugs) and tricyclic antidepressants or first-generation antihistamine with anticholinergic effects within 1 months prior to Visit 0.
8. Patients who started or changed controllers for asthma except medium-dose ICS/LABA within 1 months prior to Visit 0. (However, patients who started or changed anti-IgE, anti-IL-5, anti-IL-5 receptor alpha, anti-IL-4 receptor alpha, or anti-TSLP antibody preparations within 3 months prior to Visit 0 are excluded.)
9. Patients who received SMART therapy within 3 months prior to Visit 0.
10. Patients with upper or lower respiratory tract infections or significant changes in lung function within 1 month prior to Visit 0 or from Visit 0 to the date of administration (Visit1).
11. Patients with abnormal findings on chest radiographs taken within 12 months prior to Visit 0 that could cause cough.
12. Patients with a history of chronic lung diseases other than asthma. These chronic lung diseases include (but are not limited to) chronic obstructive pulmonary disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, bronchiectasis, and active infections such as pulmonary tuberculosis.
13. Patients with a history of malignancy under treatment.
14. Patients with angle closure glaucoma.
15. Patients with dysuria due to prostatic hypertrophy, etc.
16. Patients who cannot or are not willing to use the electronic diary record device.
17. Patients participating in interventional trials (including clinical trials) other than this study.
18. Patients who are pregnant, lactating or may be pregnant.
19. Patients who have previously experienced a safety issue with the study drug or any of its active ingredients.
20. Other patients who are judged by the principal investigator or sub-investigator to be inappropriate as research subjects.

Related Information

• Primary Sponsor: Niimi Akio
• Secondary Sponsor: Novartis Pharma K.K.