Back to resultsNext DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
CHF 1535 Next DPI
Foster BDP/Formoterol
CHF 1535 Next DPI
Foster BDP/Formoterol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Patient's written informed consent obtained prior to any study-related procedures.
- Outpatient male or female aged ≥ 18 years.
- Evidence for "partly controlled" asthma in the 2 weeks before the screening visit
- Under previous inhaled corticosteroids (ICS) treatment at the screening visit
- Forced expiratory volume in the first second (FEV1) ≥ 60% and ≤ 90% of the predicted normal values at the screening visit.
- A documented positive response to the reversibility test at the screening visit, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, 30 minutes after 400 μg salbutamol pMDI
- Patients free of long-acting beta2-agonists (LABAs) treatment for at least 2 weeks before the screening visit.
- Patients free of short-acting beta2-agonists (SABAs) treatment for at least 6 hours before the screening visit.
- Non-smokers or ex-smokers
Exclusion Criteria:
- Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they are menopausal or are using effective and acceptable methods of contraception.
- 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, hospitalisation for asthma exacerbation in Intensive Care Unit) within 1 year before screening.
- Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
- Diagnosis of restrictive lung disease.
- Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
- Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
- Allergy, sensitivity or intolerance to study drugs or excipients.
- Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality.
Sites / Locations
- Pr DS SINGH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
5
Arm Description
CHF 1535 DPI : BDP/Formo 400/24 µg
CHF 1535 pMDI HFA : BDP/Formo 400/24 µg
CHF 1535 DPI : BDP/Formo 100/6 µg
CHF 1535 pMDI HFA : BDP/Formo 100/6 µg
Placebo
Outcomes
Primary Outcome Measures
FEV1 AUC0-12h
Secondary Outcome Measures
FVC as assessed at the same time points as for FEV1; Peak FEV1 in terms of absolute values and % of change from baseline Safety evaluation
Full Information
NCT ID
NCT00868023
First Posted
March 23, 2009
Last Updated
March 28, 2017
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT00868023
Brief Title
Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients
Official Title
A Phase II, Multinational, Multicentre, Double Blind, Double Dummy, Randomised, 5-way Cross-over, Placebo and Active Controlled Clinical Study to Test the Non-inferiority of a Single Dose of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg Dry Powder) Via NEXT™ DPI 1 or 4 Inhalations Versus CHF 1535 (Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg) pMDI With HFA-134a Propellant 1 or 4 Puffs on FEV1 AUC0-12h in Partly Controlled Adult Asthmatic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over
Detailed Description
To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a "extrafine" pMDI in partly controlled adult asthmatic patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
CHF 1535 DPI : BDP/Formo 400/24 µg
Arm Title
2
Arm Type
Active Comparator
Arm Description
CHF 1535 pMDI HFA : BDP/Formo 400/24 µg
Arm Title
3
Arm Type
Experimental
Arm Description
CHF 1535 DPI : BDP/Formo 100/6 µg
Arm Title
4
Arm Type
Active Comparator
Arm Description
CHF 1535 pMDI HFA : BDP/Formo 100/6 µg
Arm Title
5
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
CHF 1535 Next DPI
Intervention Description
CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
Intervention Type
Drug
Intervention Name(s)
Foster BDP/Formoterol
Intervention Description
BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
Intervention Type
Drug
Intervention Name(s)
CHF 1535 Next DPI
Intervention Description
CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)
Intervention Type
Drug
Intervention Name(s)
Foster BDP/Formoterol
Intervention Description
BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
FEV1 AUC0-12h
Time Frame
Every week
Secondary Outcome Measure Information:
Title
FVC as assessed at the same time points as for FEV1; Peak FEV1 in terms of absolute values and % of change from baseline Safety evaluation
Time Frame
Every week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient's written informed consent obtained prior to any study-related procedures.
Outpatient male or female aged ≥ 18 years.
Evidence for "partly controlled" asthma in the 2 weeks before the screening visit
Under previous inhaled corticosteroids (ICS) treatment at the screening visit
Forced expiratory volume in the first second (FEV1) ≥ 60% and ≤ 90% of the predicted normal values at the screening visit.
A documented positive response to the reversibility test at the screening visit, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, 30 minutes after 400 μg salbutamol pMDI
Patients free of long-acting beta2-agonists (LABAs) treatment for at least 2 weeks before the screening visit.
Patients free of short-acting beta2-agonists (SABAs) treatment for at least 6 hours before the screening visit.
Non-smokers or ex-smokers
Exclusion Criteria:
Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they are menopausal or are using effective and acceptable methods of contraception.
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, hospitalisation for asthma exacerbation in Intensive Care Unit) within 1 year before screening.
Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.
Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
Diagnosis of restrictive lung disease.
Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
Allergy, sensitivity or intolerance to study drugs or excipients.
Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Singh, Professor
Organizational Affiliation
Medecines Evaluation Unit - Southmoor Road - M23 9QZ Manchester - UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pr DS SINGH
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2008-004842-10
Description
Study Record on EU Clinical Trials Register including results
Learn more about this trial
Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients
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