Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)
This study has been completed.
Sponsor:
Chiesi Farmaceutici S.p.A.
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
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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:
- Male and female patients 18-50 years of age, who have signed an informed consent form.
- Clinical evidence of asthma
- Steroid naïve asthmatic patients
- FEV1 at Screening Visit is >70 % of the predicted value and at least 2.0 L.
- Body Mass Index between 18 and 35.
- Sensitivity to AMP at Screening Visit.
- FENO levels >25 ppb at the Screening Visit
Exclusion Criteria:
- Having received an investigational product within 2 months of Screening Visit.
- Inability to comply with study procedures or with study treatment intake.
- Any significant lung disease which is considered by the investigator to be clinically significant.
- Patients who suffer from Chronic Obstructive Pulmonary Disease (COPD)
- Previous or current smokers who have a smoking history greater than 5 pack years.
- 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.
- Patients with QTc >450msec at the Screening Visit.
- Patients with serum potassium <3.5 mEq/L or >6 mEq/L.
- Intolerance/hypersensitivity or any contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
- Patients who have a history of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.
- Patients who have undergone major surgery in the previous 3 months.
- Patients who have had an exacerbation of asthma, requiring treatment with oral steroids during the last month prior to Screening Visit.
- Patients treated with slow-release corticosteroids 2 months prior to Screening Visit.
- Patients currently treated with anti-IgE Antibodies.
- Patients who have had a respiratory tract infection within 4-weeks prior to Screening Visit.
- Females not willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD).
- Females who are pregnant, lactating or planning to become pregnant
Contacts and Locations
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:
|
Beclomethasone Formoterol Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists 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 Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013