Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients

This study has been completed.
Sponsor:
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00868023
First received: March 23, 2009
Last updated: December 22, 2010
Last verified: December 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 69
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)
Active Comparator: 2
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)
Experimental: 3
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)
Active Comparator: 4
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
Placebo Comparator: 5
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

Locations
United Kingdom
Pr DS SINGH
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: Pr SD Singh, Medecines Evaluation Unit - Southmoor Road - M23 9QZ Manchester - United Kingdom
ClinicalTrials.gov Identifier: NCT00868023     History of Changes
Other Study ID Numbers: CCD-0809-PR-0038
Study First Received: March 23, 2009
Last Updated: December 22, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Formoterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014