Efficacy and safety of Salmeterol/Fluticasone DPI HEXAL versus Seretide™ Accuhaler™ in adolescent and adult patients with moderate-to-severe persistent asthma: A 12-week, multicenter, randomized, double-blind, double-dummy, parallel group study

• Conditions: moderate-to-severe persistent asthma; MedDRA version: 9.1Level: LLTClassification code 10003555Term: Asthma bronchial

• Registration Number: EUCTR2007-005620-32-LT
• Lead Sponsor: HEXAL AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

Inclusion criteria at Visit -1
1.Male or female patients aged 12 to 65 years
2.Written informed consent signed by the patient or for patients younger than 18 years (adolescents) signed according to local requirements by one or both of the patient’s parent(s) or legal representative and by the patient, if applicable, prior to any protocol specific procedures
3.Medical history of moderate-to-severe persistent asthma (according to GINA) of at least 6 months duration
4.Regular use of ICS or ICS plus LABA over the 6 months preceding Visit -1
5.Regular treatment with high-dose ICS alone or low- to high-dose ICS plus LABA within the 4 weeks preceding Visit -1 (see Appendix V for daily dosages of ICS according to GINA)
6.FEV1 = 50% of the predicted value by the European Community for Coal and Steel (ECCS) after a washout period of at least 6 hours for rapid-acting beta 2-agonists (RABA) and at least 12 hours for LABA
7.Reversible and variable airflow limitation at Visit -1: At least 12% and 200 ml increase of FEV1 compared to baseline after the stepwise reversibility test
8.Ability to read and write and to fill in the patient diary and the patient’s device preference questionnaire
9.Ability to handle correctly the asthma monitor
10.Capable to handle and to inhale from the investigational devices
Additional inclusion criteria at V0
11.FEV1 = 50% and < 80% of the predicted value by the European Community for Coal and Steel (ECCS) after a washout period of at least 6 hours for RABA (reliever medication)
12.FEV1 pre-inhalation within +/- 15% of the value obtained at Visit -1
13.At least 2 of the following criteria fulfilled during the last 7 days of the run-in period:
13.1.Nighttime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 1 day
13.2.Daytime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 3 days
13.3.Use of RABA for symptomatic relief (not prophylaxis) on at least 4 days

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Intermittent or persistent mild asthma as defined by GINA
2.Evidence of any active concomitant pulmonary disease other than asthma, i.e. chronic bronchitis, COPD
3.Respiratory tract infection (including sinusitis) and middle ear infection within 4 weeks prior to Visit -1
4.Acute asthma exacerbation within 4 weeks preceding Visit -1
5.Acute asthma exacerbation requiring hospitalization or emergency room visit within 12 weeks preceding Visit -1
6.History of life-threatening acute attacks or intubation for asthma
7.History of seasonal asthma exacerbation
8.History of paradoxical bronchospasm after inhaled asthma therapy
9.Active or inactive lung tuberculosis
10.Smoking habits: current smokers or smokers who stopped smoking less than 6 months before Visit -1 or former smokers with a history of = 10 pack-years.
11.Overdependence on RABA, i.e. frequency of RABA inhalation not consistent with controlled moderate-to-severe persistent asthma
12.Patients naive for inhaled corticosteroids
13.Change in asthma medication or regimen (other than inhalation of RABA) within 4 weeks preceding Visit -1
14.Administration of cromones within 4 weeks preceding Visit -1
15.Administration of oral, nasal, rectal, parenteral or depot corticosteroids within 4 weeks preceding Visit -1
16.More than 2 courses of oral corticosteroids within the last 12 weeks
17.Theophylline, leukotriene modifiers and anticholinergics within 4 weeks preceding Visit -1
18.Long-acting antihistamines within 1 week preceding Visit -1 (astemizole within 12 weeks)
19.Use of ß-blockers, non-potassium sparing diuretics or potent inhibitors of the cytochrome P450-3A4 system like ketoconazole, itraconazole, ritonavir within 4 weeks preceding Visit -1
20.Vaccination with live-attenuated virus within 2 weeks preceding Visit -1
21.Impaired adrenal cortex function
22.Severe renal or hepatic disease
23.Hypokalaemia uncorrected and/or serum potassium value on Visit -1 less than 3.5 mmol/L
24.Acute or history of severe cardiovascular disorders (New York Heart Association class II-IV heart failure, heart rhythm abnormalities)
25.Untreated or unstable hypertension
26.Known diabetes of all types
27.Hyperthyroidism not adequately controlled
28.Glaucoma
29.History of hypersensitivity to at least one of the active ingredients of the investigational products or the reliever medication
30.History of allergy to lactose or milk protein or – as judged by the investigator – of intolerance to small amounts of lactose
31.Presence of any other severe decompensated concomitant disease (endocrine, hematological, neurological, immunological)
32.Known active and significant pulmonary abnormalities as detected on available chest radiographs
33.Other relevant medical condition, ECG abnormality, or laboratory profile that might compromise the patient’s safety, compliance, or interfere with the evaluation or preclude completion as judged by the investigator or other contraindication to the investigational drug or the reliever medication
34.Pregnant or nursing women
35.Females of childbearing potential (not surgically sterilized / hysterectomized or postmenopausal for at least 1 year), who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices)
36.History of non-compliance with asthma management plan.
37.Suspected alcohol or drug abuse
38.Current participation in anothe

Study & Design

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