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A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma

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ClinicalTrials.gov Identifier: NCT00862394
Recruitment Status : Completed
First Posted : March 16, 2009
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids

Condition or disease Intervention/treatment Phase
Asthma Drug: BDP/Formoterol Next DPI Drug: Foster Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 783 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-week, Multinational, Randomised, Double Blind, Double Dummy, 4-arm Parallel-group Study Comparing the Efficacy and Safety of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation, Via HFA Pressurised Inhalation Solution, in Moderate to Severe Symptomatic Asthmatic Patients Aged ≥ 12 Years Under Treatment With Inhaled Corticosteroids
Study Start Date : February 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 1
CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg
Drug: BDP/Formoterol Next DPI
BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)

Active Comparator: 2
CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg
Drug: Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)

Experimental: 3
CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg
Drug: BDP/Formoterol Next DPI
BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)

Active Comparator: 4
CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg
Drug: Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)




Primary Outcome Measures :
  1. Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic [ Time Frame: 3 month period ]

Secondary Outcome Measures :
  1. Pre-dose FEV1 [ Time Frame: every month ]
  2. Post-dose FEV1 AUC 0-8 h [ Time Frame: 3 month period ]
  3. FVC and FEF 25-75% [ Time Frame: every month ]
  4. PEF [ Time Frame: every day ]
  5. Morning and evening asthma clinical symptoms scores [ Time Frame: every day ]
  6. Moderate and severe exacerbations [ Time Frame: every month ]
  7. Rescue medication [ Time Frame: every day ]
  8. Sputum [ Time Frame: 3 month period ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Outpatients of both sexes, aged > 12 years
  • Moderate to severe symptomatic asthma
  • Forced expiratory volume in the first second (FEV1) > 40% and < 80% of the predicted normal values
  • Reversibility test
  • "Partly controlled" asthma (GINA revised 2006)
  • Patients free of long-acting beta2-agonists (LABAs) treatment
  • Under inhaled corticosteroids (ICS) treatment
  • A minimum inspiratory flow ≥ 40 L/min 10.
  • Non-smokers or ex smokers
  • Asthma Control Questionnaire ACQ score ≥ 1.5

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, UNLESS they are menopausal or have 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
  • Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
  • Diagnosis 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 2 months (3 months for parenteral depot corticosteroids)
  • Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
  • Allergy to any component of the study treatments
  • Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
  • Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
  • Patients with abnormal QTc

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862394


Locations
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Germany
Oliver Kornmann - National Coordinator in Germany
Mainz, Germany, 55131
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Additional Information:
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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT00862394    
Other Study ID Numbers: CCD-0705-PR-0027
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
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