Next DPI LABA, Multicentre, 5-Way Cross-Over, Adult Asthmatic Patients - Full Text View

Sponsored by:	Chiesi Farmaceutici S.p.A.
Information provided by:	Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:	NCT00868023

Purpose

Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over

Condition	Intervention	Phase
Asthma	Drug: CHF 1535 Next DPI Drug: Foster BDP/Formoterol Drug: Placebo	Phase II

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Arformoterol Tartrate Beclomethasone Beclomethasone dipropionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:

FEV1 AUC0-12h [ Time Frame: Every week ] [ Designated as safety issue: No ]

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 [ Time Frame: Every week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	95
Study Start Date:	February 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental CHF 1535 DPI : BDP/Formo 400/24 µg	Drug: CHF 1535 Next DPI CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
2: Active Comparator CHF 1535 pMDI HFA : BDP/Formo 400/24 µg	Drug: Foster BDP/Formoterol BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
3: Experimental CHF 1535 DPI : BDP/Formo 100/6 µg	Drug: CHF 1535 Next DPI CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)
4: Active Comparator CHF 1535 pMDI HFA : BDP/Formo 100/6 µg	Drug: Foster BDP/Formoterol BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg
5: Placebo Comparator Placebo	Drug: Placebo Placebo

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868023

Contacts

Contact: Martine Cartier

+33147684358

m.cartier@chiesifrance.com

Locations

United Kingdom
Pr DS SINGH	Recruiting
Manchester, United Kingdom, M23 9QZ

Sponsors and Collaborators

Chiesi Farmaceutici S.p.A.

Investigators

Principal Investigator:

David Singh, Professor

Medecines Evaluation Unit - Southmoor Road - M23 9QZ Manchester - UK

More Information

No publications provided

Responsible Party:	Medecines Evaluation Unit - Southmoor Road - M23 9QZ Manchester - United Kingdom ( Pr SD Singh )
Study ID Numbers:	CCD-0809-PR-0038
Study First Received:	March 23, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00868023 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Italy: Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Adrenergic Agents
Adrenergic beta-Agonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Asthma
Beclomethasone

Anti-Asthmatic Agents
Glucocorticoids
Hormones
Adrenergic Agonists
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Beclomethasone
Anti-Asthmatic Agents

Glucocorticoids
Hormones
Pharmacologic Actions
Adrenergic Agonists
Autonomic Agents
Therapeutic Uses
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 07, 2009