Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)

This study has been completed.
Sponsor:
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01343745
First received: April 21, 2011
Last updated: May 6, 2011
Last verified: May 2011
  Purpose

The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose response.


Condition Intervention Phase
Mild Persistent Asthma
Drug: BDP/formoterol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Dose Response Evaluation of CHF 1535 HFA pMDI in Asthmatic Patients Using Lung Function, Adenosine Monophosphate Bronchial Challenge and Fractional Exhaled Nitric Oxide (FENO)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • PC20 after AMP challenge [ Time Frame: 4 h post dose ] [ Designated as safety issue: No ]
    Provocative Concentration of AMP causing a 20% fall in FEV1.

  • Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: 4 h post dose ] [ Designated as safety issue: No ]
    Fractional exhaled nitric oxide (ppb). FeNO is a biomarker measured in a breath test and it is a validated method for measuring the airway inflammation in asthma.

  • Lung function [ Time Frame: from 0 to 4 h post dose ] [ Designated as safety issue: No ]
    FEV1 area under the curve from 0 to 4 hour post dose (AUC0-4h)


Secondary Outcome Measures:
  • FENO [ Time Frame: 2 h post dose ] [ Designated as safety issue: No ]
    Fractional exhaled nitric oxide


Enrollment: 18
Study Start Date: February 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo pMDI
Drug: Placebo
pressurised metered dose inhaler
Experimental: Low dose
BDP/formoterol pMDI low dose
Drug: BDP/formoterol
pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 1 inhalation bid (total daily dose 200 µg BDP + 12 µg formoterol)
Other Name: Foster
Experimental: High dose
BDP/Formoterol pMDI high dose
Drug: BDP/formoterol
pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol)
Other Name: Foster

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients 18-50 years of age, who have signed an informed consent form.
  2. Clinical evidence of asthma
  3. Steroid naïve asthmatic patients
  4. FEV1 at Screening Visit is >70 % of the predicted value and at least 2.0 L.
  5. Body Mass Index between 18 and 35.
  6. Sensitivity to AMP at Screening Visit.
  7. FENO levels >25 ppb at the Screening Visit

Exclusion Criteria:

  1. Having received an investigational product within 2 months of Screening Visit.
  2. Inability to comply with study procedures or with study treatment intake.
  3. Any significant lung disease which is considered by the investigator to be clinically significant.
  4. Patients who suffer from Chronic Obstructive Pulmonary Disease (COPD)
  5. Previous or current smokers who have a smoking history greater than 5 pack years.
  6. Patients with any uncontrolled disease that might, in the judgment of the investigator, place the patients at undue risk or potentially compromise the results or interpretation of the study.
  7. Patients with QTc >450msec at the Screening Visit.
  8. Patients with serum potassium <3.5 mEq/L or >6 mEq/L.
  9. Intolerance/hypersensitivity or any contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
  10. Patients who have a history of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.
  11. Patients who have undergone major surgery in the previous 3 months.
  12. Patients who have had an exacerbation of asthma, requiring treatment with oral steroids during the last month prior to Screening Visit.
  13. Patients treated with slow-release corticosteroids 2 months prior to Screening Visit.
  14. Patients currently treated with anti-IgE Antibodies.
  15. Patients who have had a respiratory tract infection within 4-weeks prior to Screening Visit.
  16. Females not willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD).
  17. Females who are pregnant, lactating or planning to become pregnant
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01343745

Locations
United Kingdom
Respiratory Clinical Trials - Heart Lung Centre - Queen Anne Street Medical Centre
London, 18-22 Queen Anne Street, United Kingdom, W1G 8HU
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Brian J O'Connor, MD Heart Lung Centre
  More Information

No publications provided by Chiesi Farmaceutici S.p.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sara Collarini, Clinical Study Manager, Chiesi Farmaceutici SpA
ClinicalTrials.gov Identifier: NCT01343745     History of Changes
Other Study ID Numbers: FB/PS/14/169/07, 2007-004345-14
Study First Received: April 21, 2011
Last Updated: May 6, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014