AN OPEN STUDY TO ASSESS THE ROBUSTNESS OF THE CRC749 DEVICE BY PHARMACEUTICAL PERFORMANCE FOLLOWING TWICE DAILY DOSING OF MGR001 ADMINISTERED VIA ORAL INHALATION IN SUBJECTS WITH ASTHMA OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
- Conditions
- Asthma or chronic obstructive pulmonary disease (COPD)MedDRA version: 18.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 18.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-000463-13-GB
- Lead Sponsor
- Mylan Pharma UK Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
Asthma
1. Evidence of a personally signed and dated informed consent (and assent, if applicable) document indicating that the subject (and parent/legal guardian, if applicable) has been informed of all pertinent aspects of the study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan, and all other study procedures.
3. Male or female subjects aged =12 years at the time of consent. Females may be of either childbearing or non-childbearing potential. All females of childbearing potential (including adolescents) must be either abstinent from sexual intercourse or using adequate contraception and must also have a negative urine pregnancy test. Pregnant or nursing females or females intending to become pregnant during the course of the study must be excluded from the study.
4. A physician diagnosed history of asthma for at least 12 weeks prior to Visit 1 - Screening.
5. Stable treatment using an established maintenance therapy for asthma at a
constant dosage or regular use of rescue medication (i.e. =2 doses of SABA
per week) during the last 4 weeks prior to Visit 1 - Screening.
6. Asthma subjects should have a Visit 1 - Screening pre-bronchodilator FEV1 =50% of predicted values according to age, height, race and sex.
7. Subjects must be able to use the inhaler as assessed at Visit 2 - (Day 1) (according to the Instructions for Use).
COPD
1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
2. Subjects who are willing and able to comply with scheduled visits, treatment plan and all other study procedures
3. Male or female subjects aged =40 years at the time of consent. Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be either abstinent from sexual intercourse or using adequate contraception and must also have a negative urine pregnancy test. Pregnant or nursing females or females intending to become pregnant during the course of the study must be excluded from the study
4. A physician diagnosed history of COPD for at least 12 weeks prior to Visit 1 - Screening
5. Stable treatment using an established maintenance therapy or regular rescue therapy (e.g. =2 doses of SABA and/or SAMA per day) for COPD at a constant dosage during the last 4 weeks prior to Visit 1 - Screening
6. COPD subjects should have a Visit 1 - Screening post-bronchodilator FEV1 =40% predicted according to age, height, race and sex and FEV1/FVC ratio of <0.7
7. Subjects must be able to use the inhaler as assessed at Visit 2 - (Day 1) (according to the Instructions for Use)
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3
Asthma/COPD
•Lower respiratory tract infection requiring treatment with antibiotics during 28 days preceding Visit1-Screening or prior to Visit2-Day1
•History of malignancy of any organ system treated or untreated, within past 5 years whether or not there is evidence of local recurrence or metastases. The only exceptions are previous in situ carcinoma of the cervix, localized basal cell or localized squamous carcinoma of the skin if the patient has been treated and is considered cured
•If currently using ICS/LABA, LABA or ICS, an inability to stop medication the day prior Visit2-Day1 and switch to MGR001 for duration of study
•Use of prescription or non-prescription drugs:
-Medication contraindicated in Advair Diskus or salbutamol product labels or with potential to affect the course of asthma or interact with sympathomimetic amines are excluded within 28 days of first dose of study treatment and throughout study
-Potent cytochrome P-450 3A4 inhibitors (eg ritonavir and ketoconazole)
-Non-cardioselective beta-blockers
-Tricyclic anti-depressants (regardless of indication)
-Phenothiazines, eg chlorpromazine
-Monoamine oxidase inhibitors
-Herbal medicines
•Suspected hypersensitivity to sympathomimetic drug (eg salmeterol or salbutamol) or orally inhaled, intranasal or systemic corticosteroid therapy or ingredients of study drug (eg lactose) or severe milk protein allergy
•Subjects in whom Advair Diskus/Seretide Accuhaler are contraindicated
•Known history of hypothalamic pituitary adrenal axis dysfunction eg hypo/hyper-adrenalism
Asthma
1.Presence or recent history, based on complete medical history, full physical examination or 12-lead ECG of any other active, severe, progressive, and/or uncontrolled clinical disease (eg renal, hepatic, gastrointestinal, metabolic, endocrine, cardiac, pulmonary, or neurological) other than asthma: Poorly controlled Type1 or Type2 diabetes, Seizure disorder or epilepsy, Cerebrovascular accident, Significant cardiac conduction abnormalities
Stable, well-controlled conditions such as allergic rhinitis, controlled hypertension, thyroid disease, controlled Type1 and Type2 diabetes, hypercholesterolemia or gastroesophageal reflux are acceptable provided symptoms and medication would not compromise safety or interfere with tests and interpretation of the study would be allowed
2.Evidence of significant respiratory conditions other than asthma and allergic rhinitis, inc. but not limited to: severe nasal polyposis or chronic rhinosinusitis, COPD, clinically significant bronchiectasis, Churg-Strauss Disease, lung resection, pulmonary fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis
3.Significant (determined by Investigator) disease instability/uncontrolled asthma, necessitating exclusion from study following Investigator review
4.History of life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method