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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Beclomethasone
Formoterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014