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

Chiesi

Status and phase: Completed; Phase 2

Conditions: Mild Persistent Asthma

Treatments: Drug: BDP/formoterol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01343745

2007-004345-14 (EudraCT Number)

FB/PS/14/169/07

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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18 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo pMDI

Treatment:

Drug: Placebo

Low dose

Experimental group

Description:

BDP/formoterol pMDI low dose

Treatment:

Drug: BDP/formoterol

Drug: BDP/formoterol

High dose

Experimental group

Description:

BDP/Formoterol pMDI high dose

Treatment:

Drug: BDP/formoterol

Drug: BDP/formoterol