Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01343745 |
Recruitment Status :
Completed
First Posted : April 28, 2011
Last Update Posted : October 29, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
- PC20 after AMP challenge [ Time Frame: 4 h post dose ]Provocative Concentration of AMP causing a 20% fall in FEV1.
- 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.
- 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)
- FENO [ Time Frame: 2 h post dose ]Fractional exhaled nitric oxide

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United Kingdom | |
Respiratory Clinical Trials - Heart Lung Centre - Queen Anne Street Medical Centre | |
London, United Kingdom, W1G 8HU |
Principal Investigator: | Brian J O'Connor, MD | Heart Lung Centre |
Publications of Results:
Responsible Party: | Chiesi Farmaceutici S.p.A. |
ClinicalTrials.gov Identifier: | NCT01343745 |
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: | October 29, 2021 |
Last Verified: | October 2021 |
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 |