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

NCT01343745 | Completed Phase 2

• 2 other identifiers: FB/PS/14/169/072007-004345-14
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Persistent Asthma

Outcome Measures

Primary Outcomes (3)

• PC20 after AMP challenge

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

  4 h post dose

• Fractional Exhaled Nitric Oxide (FeNO)

  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

  FEV1 area under the curve from 0 to 4 hour post dose (AUC0-4h)

  from 0 to 4 h post dose

Secondary Outcomes (1)

• FENO

  2 h post dose

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo pMDI

Drug: Placebo

Low dose

EXPERIMENTAL

BDP/formoterol pMDI low dose

Drug: BDP/formoterol

High dose

EXPERIMENTAL

BDP/Formoterol pMDI high dose

Drug: BDP/formoterol

Interventions

BDP/formoterol DRUG

pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol)

Also known as: Foster

High dose

Placebo DRUG

pressurised metered dose inhaler

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Respiratory Clinical Trials - Heart Lung Centre - Queen Anne Street Medical Centre

London, W1G 8HU, United Kingdom

Location

Related Publications (1)

• O'Connor BJ, Collarini S, Poli G, Brindicci C, Spinola M, Acerbi D, Barnes PJ, Leaker B. Rapid effects of extrafine beclomethasone dipropionate/formoterol fixed combination inhaler on airway inflammation and bronchoconstriction in asthma: a randomised controlled trial. BMC Pulm Med. 2011 Dec 21;11:60. doi: 10.1186/1471-2466-11-60.

  PMID: 22188731 RESULT

Related Links

• Study Record on EU Clinical Trials Register including results
• CSR Synopsis available in the CHIESI Clinical Study Register

MeSH Terms

Interventions

Foster Home Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Brian J O'Connor, MD

  Heart Lung Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 28, 2011
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

GB (1)