Study on effectiveness of Flutiform® asthma inhaler

Phase 1

Active, not recruiting

• Conditions: Asthma; MedDRA version: 16.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 16.1Level: PTClassification code 10038683Term: Respiratory disorderSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-005365-39-GB
• Lead Sponsor: Research in Real-Life Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-05
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

To be included in phase 1 of the study, all of the criteria below need to be met:

1) Able and willing to provide written informed consent and to comply with the study protocol
2) Current diagnosis of asthma (as evidenced by appropriate diagnostic code)
3) Step 4 of the BTS guidelines
4) Received at least 4 inhalers of Seretide® 250 Evohaler® 2 puffs twice daily in the last 6 months (corresponds to =66% compliance)
5) No asthma exacerbation* in last 3 months
6) =2 exacerbations* in last 12 months
7) No critical errors in device use after training (during baseline visit)
8) Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after discontinuation of study drug. Acceptable methods of contraception include intrauterine device (IUD) known to have a failure rate of less than 1% per year, steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, and partner vasectomy.

* Exacerbation defined as acute course of oral steroids, emergency room attendance and/or hospitalisation for asthma

Only patients who received Flutiform and did not have any exacerbations in phase 1 will be eligible for phase 2 of the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 164
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1) Chronic respiratory disease other than asthma
2) Uncontrolled asthma (according to the Global Initiative for Asthma (GINA) criteria)
3) Participation in a clinical study within the past year
4) Hypersensitivity to Flutiform®, its component Formoterol or its excipients
5) Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified