Double-blind, placebo-controlled, parallel group, study of ICS/LABA/LAMA on cough symptoms in adult patients with asthma

JRCT ID: jRCTs031210412

Registered date:08/11/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Bronchial asthma
• Date of first enrollment: 26/07/2022
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Investigational drug group dosage: FF/UMEC/VI 200 mcg/62.5 mcg/25 mcg is administered by inhalation once daily for 6 weeks
Placebo group dosage: Placebo of FF/UMEC/VI is administered by inhalation once daily for 6 weeks

Outcome(s)

• Primary Outcome: Mean change from baseline in cough symptoms score over Week-6 (eDaily Diary)

Secondary Outcome

- Cough symptoms score (eDaily Diary), weekly mean changes from baseline (Week 1-5)
- Cough severity score (eDaily Diary), weekly mean changes from baseline (Week 1-6)
- Cough frequency score (eDaily Diary), weekly mean changes from baseline (Week 1-6)
- Night-time awakenings score (eDaily Diary), weekly mean changes from baseline (Week 1-6)
- Mean change from baseline in Leicester Cough Questionnaire (LCQ) at Week 3 and 6
- Mean change from baseline in Asthma Control Questionnaire (ACQ)-7/6/5 at Week 1, 3 and 6
- % change from baseline in weekly rescue salbutamol use (number of inhalations)
- % rescue salbutamol free days during treatment period (Day 1-42)
- Mean change from baseline in Asthma Control Test (ACT) at Week 6
- Daily or weekly mean changes from baseline in morning/evening peak expiratory flow (PEF) (eDaily Diary) during treatment period (Day 1-42)
- Daily or weekly mean changes from baseline in morning/evening forced expiratory volume in 1 second (FEV1) (eDaily Diary) during treatment period ( Day 1-42)
- Mean % change from baseline in FeNO at Week 1, 3 and 6
- Weekly changes from baseline in the proportion of days with a night-time awakenings score (eDaily Diary) of 0
- Proportion of subjects with a night-time awakenings score (eDaily Diary) of 0 on Week 1, Week 3 and Week 6
- Subgroup analyses stratified by airway reversibility, %FEV1, FeNO and Blood eosinophil counts

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Participant must be 20 years of age or older, at the time of signing the informed consent.
2)Outpatients who have subjective persistent-cough symptoms caused by asthma (minimum of 4 weeks of persistent-cough symptoms).
3)Any inhaled corticosteroid (ICS) are not used within 6 weeks prior to Visit 1.
4)No history of severe asthma exacerbation (severe asthma exacerbation by ATS/ERS definition: oral corticosteroid use and/or hospitalization or ED visit) within 12 weeks prior to Visit 1
5)In the pulmonary function test and airway reversibility test on Visit 1, a pre-bronchodilator 60% =< FEV1 =< 90% of the predicted normal value at the Visit 1 OR Airway reversibility confirmed by >=12% and >=200 mL of improvement in post-bronchodilator FEV1.
6)FeNO >=25 ppb at the Visit 1

Exclude criteria

1)Current smokers OR Ex-smokers who quit smoking within 1 year of Visit 1 OR Ex-smokers with a smoking history of >10 pack-years.
2)Subject with a history of life-threatening asthma attack within the last 10 years
3)Subject with a respiratory tract infection or sinus infection that is not resolved by 8 weeks before Visit 1
4)Subject with a current diagnosis of respiratory diseases other than asthma (e.g., COPD, bronchiectasis, interstitial lung disease, bronchopulmonary dysplasia)
5)Subject with other causes of cough including symptomatic gastro-oesophageal reflux or symptomatic post nasal drip or COVID-19
6)Subject has received any systemic steroid and/or antibiotics within 8 weeks prior to Visit 1
7)Immunosuppressive medications: A subject must be using or require use of immunosuppressive medications during the study.
8)Cytochrome P450 3A4 (CYP3A4) inhibitors: A Subject has received a potent CYP3A4 inhibitor within 4 weeks prior to Visit 1 (e.g., ritonavir, ketoconazole, itraconazole).
9)PPI or antacids: A subject must be using or require use of PPI or antacids for dyspepsia during the study.
10)ACE inhibitors: A subject must be using or require use of ACE inhibitors during the study.
11)Biological products: A subject has received any biological product indicated for bronchial asthma within 12 weeks prior to Visit 1.

Related Information

• Primary Sponsor: Tagaya Etsuko
• Source(s) of Monetary Support: GlaxoSmithKline Pharmaceuticals Ltd