Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004345-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo pMDI |
|
| Low dose | Experimental | BDP/formoterol pMDI low dose |
|
| High dose | Experimental | BDP/Formoterol pMDI high dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDP/formoterol | Drug | pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| FENO | Fractional exhaled nitric oxide | 2 h post dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian J O'Connor, MD | Heart Lung Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Clinical Trials - Heart Lung Centre - Queen Anne Street Medical Centre | London | W1G 8HU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22188731 | Result | 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. |
| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D005581 | Foster Home Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D003153 | Community Health Services |
| D006296 | Health Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BDP/formoterol | Drug | pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 1 inhalation bid (total daily dose 200 µg BDP + 12 µg formoterol) |
|
|
| Placebo | Drug | pressurised metered dose inhaler |
|
| D005159 |
| Health Care Facilities Workforce and Services |