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

October 28, 2021 updated by: Chiesi Farmaceutici S.p.A.

Dose Response Evaluation of CHF 1535 HFA pMDI in Asthmatic Patients Using Lung Function, Adenosine Monophosphate Bronchial Challenge and Fractional Exhaled Nitric Oxide (FENO)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W1G 8HU
        • Respiratory Clinical Trials - Heart Lung Centre - Queen Anne Street Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol)
Other Names:
  • Foster
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PC20 after AMP challenge
Time Frame: 4 h post dose
Provocative Concentration of AMP causing a 20% fall in FEV1.
4 h post dose
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.
4 h post dose
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)
from 0 to 4 h post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FENO
Time Frame: 2 h post dose
Fractional exhaled nitric oxide
2 h post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Brian J O'Connor, MD, Heart Lung Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimate)

April 28, 2011

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FB/PS/14/169/07
  • 2007-004345-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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