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

Sponsor
Chiesi Farmaceutici S.p.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT01343745
Collaborator
(none)
18
Enrollment
1
Location
3
Arms
6
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 1, 2008
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

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 Names:
  • 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 Names:
  • Foster

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PC20 after AMP challenge [4 h post dose]

      Provocative Concentration of AMP causing a 20% fall in FEV1.

    2. Fractional Exhaled Nitric Oxide (FeNO) [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 [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 [2 h post dose]

      Fractional exhaled nitric oxide

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Chiesi Farmaceutici S.p.A.
    ClinicalTrials.gov Identifier:
    NCT01343745
    Other Study ID Numbers:
    • FB/PS/14/169/07
    • 2007-004345-14
    First Posted:
    Apr 28, 2011
    Last Update Posted:
    Oct 29, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:
    Formoterol Fumarate

    Study Results

    No Results Posted as of Oct 29, 2021