Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.
Study Identifier:
CCD-01535BA0-01
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Trial Documents
Protocol
Available Languages: English
Statistical Analysis Plan
Available Languages: English
Clinical Study Report
Available Languages: English
Plain Language Summary
Available Languages: Chinese (China), English
Study Details
Medical Condition
- Asthma
Study Drug
- Drug: Foster 100/6µg NEXThaler
- Drug: Foster 100/6µg pMDI
Date
Oct 2017 - Dec 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male or female outpatients, Chinese ethnicity aged ≥18 years, who signed an ICF prior to initiation of any study-related procedure;
- Clinical diagnosis of asthma for a minimum of 6 months prior to V1 (Week -4) confirmed by a chest physician according to international guidelines updated 2018 (GINA) \[1\]. The evidence of asthma had to be confirmed through a documented positive response (in the last 24 months) either to a bronchial provocation test/challenge test or a reversibility test. In case the patient did not have any documented reversibility test or provocation/challenge test, a salbutamol reversibility test was performed at V1 (Week -4) within 10 to 30 minutes after administration of 400 µg of salbutamol pMDI \[17\]. Test response was positive if ΔFEV1 ≥12% and ≥200 mL over baseline.
- Note: In case the reversibility threshold was not met at V1 (Week -4), the test could have been repeated once before V2 or at V2 (Week -2);
- FEV1 \>80% of the predicted normal value after appropriate washout from bronchodilators (checked at V1 \[Week -4\] and at the randomisation visit \[V3, Week 0\]);
- Note: If this criterion was not met:
- At V1 (Week -4), the test could have been repeated once before V2 or at V2 (Week -2);
- At randomisation visit (V3, Week 0), the test could have been repeated once within 2 days after this visit;
- ACQ-6 score \<0.75 (checked at V1 \[Week -4\] and at the randomisation visit \[V3, Week 0\]);
- Patients on previous regular treatment at a stable dose for at least 1 month prior to the screening visit (V1, Week -4) with either medium daily dose of ICS monotherapy (e.g. BDP-chlorofluorocarbons \[CFC\] \>500-1000 µg/day or equivalent dose) or high daily dose of ICS monotherapy (e.g. BDP-CFC \>1000 µg/day or equivalent dose) or low daily dose of ICS (e.g. BDP-CFC ≥200-500 µg/day or equivalent dose)/LABA free/fixed combination or medium daily dose of ICS (e.g. BDP-CFC \>500-1000 µg/day or equivalent dose)/LABA free/fixed combination;
- A cooperative attitude and ability to be trained to the proper use of DPI and pMDI inhalers and an electronic peak flow meter (checked at the screening visit \[V1, Week -4\] and at the randomisation visit \[V3, Week 0\]);
- At least seven valid pre-dose morning PEF measurements in the last 14 days of the run-in period were necessary (checked at the randomisation visit \[V3, Week 0\]).
Exclusion Criteria
- Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) unless they were using one or more of the following highly effective contraceptive measures:
- Placement of an intrauterine device or intrauterine hormone-releasing system;
- Combined (oestrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);
- Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);
- Bilateral tubal occlusion;
- Vasectomised partner;
- Sexual abstinence; Reliable contraception had to be maintained throughout the study. Any postmenopausal women (physiologic menopause defined as "12 consecutive months of amenorrhoea without an alternative medical cause") or women permanently sterilised (e.g. bilateral oophorectomy, hysterectomy or bilateral salpingectomy) could be enrolled in the study.
- Pregnancy testing was carried out during the course of the study in all women of childbearing potential: serum pregnancy test was performed at screening (V1, Week -4) and end of treatment (V9, Week 12), urine pregnancy test was performed at all visits except V0 (Week -5) and V9 (Week 12);
- Intermittent asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitiser;
- History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in an intensive care unit);
- Diagnosis of chronic obstructive pulmonary disease as defined by the current global initiative for chronic obstructive lung disease (GOLD) guidelines updated 2016 \[18\];
- Current smokers or ex-smokers with total cumulative exposure equal or more than 10 pack-years or having stopped smoking 1 year or less prior to screening (V1, Week -4);
- Severe asthma exacerbation leading to intake of systemic corticosteroids (≥10 days) within 1 month prior to inclusion or moderate/severe asthma exacerbation (according to international guidelines updated 2018 \[GINA\] \[1\]) during the run-in period (checked at the screening visit \[V1, Week -4\] and at the randomisation visit \[V3, Week 0\]);
- Lower respiratory tract infections (e.g. pneumonia) affecting the patient's asthma within 1 month prior to inclusion;
- History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease;
- Diagnosis of restrictive lung disease;
- Patients treated with oral or parenteral corticosteroids in the previous 2 months before V1 (Week -4; 3 months for parenteral depot corticosteroids);
- Intolerance or contra-indication to treatment with β2-agonists and/or ICS or allergy to any component of the study treatments;
- Having received an investigational medication within 2 months before screening (V1, Week -4);
- Patients who had a clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition (e.g. major surgery) that might have, in the judgment of the Investigator, represented for the patients an undue risk or that could have compromised the results or interpretation of the study;
- History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias;
- Clinically relevant laboratory abnormalities such as (but not limited to) hypokalaemia (\<3.5 mEq/L), that might have compromised patient's safety or compliance, interfered with evaluation, or precluded completion of the study, in the judgment of the Investigator. Patients with uncontrolled diabetes including patients with a history of fasting plasma glucose levels consistently out of the normal range (\>140 mg/dL) or HbA1C \>8%;
- Patients who had an abnormal 12-lead ECG (i.e. QRS interval \[QRS\] \>120 ms and/or PR interval \[PR\] \>210 ms and/or HR \<45 beats per minute \[bpm\] and/or HR \>110 bpm and/or Fridericia-corrected QT interval \[QTcF\] \>450 ms for males or QTcF \>470 ms for females) or 12-lead ECG evaluated as abnormal clinically significant (CS) by the Investigator, at screening (V1, Week -4);
- Patients who had a concomitant disease of poor prognosis (e.g. cancer);
- Patients treated with monoclonal antibodies (e.g. anti-immunoglobulin E \[anti-IgE\] antibodies);
- Patients treated with non-potassium sparing diuretics (unless administered at a fixed dose combination with a potassium conserving medication), non-selective β1-blocking medications, quinidine, quinidine-like antiarrhythmics or any medication with a corrected QT interval (QTc) prolongation potential, or a history of QTc prolongation;
- Patients treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants, unless already taken at stable doses in the month before screening (V1, Week -4) and without any safety concern;
- Patients who were receiving therapy that could interact with steroids, such as enzyme inhibitors (macrolides, antifungal therapy \[not topical\]) or inducers (anticonvulsants, rifampicin);
- Inability to comply with study procedures or with study treatment intake.
Healthy Volunteers
No
Protocol Summary
Primary Objective
To demonstrate the non-inferiority of Foster® NEXThaler® 100/6 µg versus (vs.) Foster® pressurised metered dose inhaler (pMDI) 100/6 µg in terms of pulmonary function (change from baseline to the entire treatment period in average pre-dose morning peak expiratory flow \[PEF\]) in asthmatic patients.
Secondary Objectives
To evaluate the effect of the test treatments in terms of additional lung function parameters and clinical outcome measures, and to assess the safety and tolerability.
Study Locations
Location
Status
Location
Chiesi Clinical Trial site 15641
Hefei, Anhui, China
Status
N/A
Location
Chiesi Clinical Trial site 15682
Beijing, Beijing Municipality, China, 100000
Status
N/A
Location
Chiesi Clinical Trial site 15663
Beijing, Beijing Municipality, China, 101100
Status
N/A
Location
Chiesi Clinical Trial site 15662
Foshan, Guangdong, China
Status
N/A
Location
Chiesi Clinical Trial site 15671
Guangzhou, Guangdong, China, 5100150
Status
N/A
Location
Chiesi clinical Trial Site 15610
Guangzhou, Guangdong, China, 510120
Status
N/A
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