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

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ClinicalTrials.gov Identifier: NCT01343745
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
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 or disease Intervention/treatment Phase
Mild Persistent Asthma Drug: BDP/formoterol Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : February 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. PC20 after AMP challenge [ Time Frame: 4 h post dose ]
    Provocative Concentration of AMP causing a 20% fall in FEV1.

  2. Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: 4 h post dose ]
    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.

  3. Lung function [ Time Frame: from 0 to 4 h post dose ]
    FEV1 area under the curve from 0 to 4 hour post dose (AUC0-4h)


Secondary Outcome Measures :
  1. FENO [ Time Frame: 2 h post dose ]
    Fractional exhaled nitric oxide



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT01343745


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

Additional Information:
Publications of Results:
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01343745     History of Changes
Other Study ID Numbers: FB/PS/14/169/07
2007-004345-14 ( EudraCT Number )
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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