- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01349257
Pharmacokinetic Clinical Study of CHF1535 NEXT DPI® Versus CHF1535 pMDI
July 30, 2020 updated by: Chiesi Farmaceutici S.p.A.
Study Title: A Single-dose, Open-label, Randomised, 2-way Crossover, Clinical Pharmacology Study of Four Inhalations of CHF 1535 100/6 NEXT DPI® (Fixed Combination of Beclomethasone Diproponate 100 µg Plus Formoterol Fumarate 6 µg) Versus the Same Dose of CHF 1535 100/6 pMDI Both Administered With Charcoal Block.
The aim of this clinical study is to compare the lung exposure of the contents of the trial drug after administration of the fixed combination between beclomethasone and formoterol delivered via the new Chiesi dry powder inhaler in comparison to the beclomethasone and formoterol delivered via the pressurised metered dose inhaler (pMDI) using a spacer device.
To determine lung exposure, the treatments are administered with charcoal block.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manchester, United Kingdom, M23 9QZ
- Medicines Evaluation Unit Ltd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female adults (≥18 and ≤ 70 years old).
- Written informed consent obtained by the patient prior to any study-related procedures.
- Diagnosis of asthma as defined by the GINA guidelines, update 2009, at least in the 6 months before the screening visit.
- Asthmatic patients already treated with low or medium daily dose of ICS (e.g. BDP or equivalent ≤ 1000 µg/die) or low dose of ICS/LABA fixed combination (e.g. salmeterol/fluticasone 100/500 µg/die).
- Patients with a pre-bronchodilator forced expiratory volume in one second (FEV1) ≥ 60% and ≤ 90% of the predicted values.
- Non or ex-smokers who smoked less than 5 pack-years and stopped smoking for at least 1 year. (Pack/year: number of cigarette smoked per day multiplied by the number of years of smoking/20).
- Ability to a proper use of pMDI plus spacer and DPI devices.
- A cooperative attitude to be compliant with study procedures.
- Body mass index (BMI) ≥18.5 and ≤ 32 kg/m2
Exclusion Criteria:
Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea or are using one or more of the following acceptable methods of contraception.
- surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
- hormonal contraception (implantable, patch, oral)
- other forms of effective contraception including placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal cream/foam/gel/ suppository.
- Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
- History of near fatal asthma (e.g. brittle asthma, hospitalization for asthma exacerbation in Intensive Care Unit).
- Patients with abnormal QTcF at Screening Visit: QTcF > 450 msec for male subjects and QTcF > 470 msec for female subjects.
- Diagnosis of COPD as defined by the current GOLD guidelines, updates 2009.
- Hospitalization due to asthma exacerbation within 1 month prior to the screening visit or during the run-in period.
- Lower respiratory tract infection within one month prior to screening until randomization.
- History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
- History of drug addiction or excessive use of alcohol (weekly intake in excess of 28 units alcohol; one unit being a glass of beer, wine or a measure of spirits), or excessive consumption of xanthine containing substances (daily intake in excess of 5 cups of coffee, tea, cola, etc) or psychological or other emotional problems likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements;
- Diagnosis of restrictive lung disease.
- Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids).
- Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
- Having received an investigational drug within 1 month before the screening visit.
- Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion.
- Any patient with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lung bioavailability
Time Frame: 13 times/24hr
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To compare the lung bioavailability of B17MP (active metabolite of BDP) and formoterol after four inhalations using the new Chiesi dry powder inhaler vs pMDI using spacer device, with activated Charcoal Block.
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13 times/24hr
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the safety and the tolerability of the study treatments considering AE and measuring vitals signs as blood pressure and heart rate in the specified time frame.
Time Frame: 13 times/24hr
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Adverse events and Vital signs: blood pressure and heart rate assessed at pre-dose and 30 min, 1, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose.
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13 times/24hr
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dave Singh, MD, Medicines Evaluation Unit Ltd, Manchester, United Kingdom
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
April 22, 2011
First Submitted That Met QC Criteria
May 5, 2011
First Posted (Estimate)
May 6, 2011
Study Record Updates
Last Update Posted (Actual)
July 31, 2020
Last Update Submitted That Met QC Criteria
July 30, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Formoterol Fumarate
Other Study ID Numbers
- CCD-1015-PR-0055
- 2010-024384-40 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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