Double-blind, double-dummy, multi-center, randomized parallel group study to demonstrate therapeutic equivalence of Salmeterol/Fluticasone DPI HEXAL versus Seretide™ 100 Accuhaler™ over a period of 12 weeks in pediatric patients with persistent moderate asthma
- Conditions
- persistent moderate asthmaMedDRA version: 9.1Level: LLTClassification code 10003555Term: Asthma bronchial
- Registration Number
- EUCTR2007-005630-36-LT
- Lead Sponsor
- HEXAL AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 216
1.Male or female children aged 4 to 11 years
2.Written informed consent signed according to local requirements by one or both of the patient’s parent(s) or the legal representative and by the patient, if applicable, prior to any protocol specific procedures
3.Medical history of persistent moderate 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 medium- to high-dose ICS or medium-dose ICS plus LABA for children <5 years, high-dose ICS or low- to medium-dose ICS plus LABA for children >5 years within the 4 weeks preceding Visit -1
6.Ability to perform spirometric maneuvers with a forced expiratory time of at least 1 second
7.FEV1 > 60% 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
8.Reversible and variable airflow limitation: at least 12% increase of FEV1 compared to baseline after the stepwise reversibility test
9.Ability to read and write and to fill in the patient diary by the patient or by patient’s parent(s) or legal representative
10.Ability to handle correctly the peak flow meter
11.Capable to handle and inhale from the investigational devices.
12.FEV1 greater than 60% and less than 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)
13.FEV1 within +/- 15% of the value obtained at Visit -1
14.At least 2 of the following criteria fulfilled during the last 7 days of the run-in period:
14.1.Nighttime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 1 day
14.2.Daytime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 3 days
14.3. 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) no
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
1.Intermittent or persistent mild or severe 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
11.Overdependence on RABA, i.e. frequency of RABA inhalation not consistent with persistent moderate 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 beta-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
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.Girls of childbearing potential, not willing to abstain from sexual activities throughout complete duration of participation in the study, pregnancy or nursing
35.History of non-compliance with asthma management plan
36.Suspected alcohol or drug abuse
37.Current participation in another investigational drug study, or previous participation within 1 month prior to Visit -1 in the HEXAL study with protocol no. 2007-41-DOS-3 or participation in any other clinical study involving an investigational drug within 3 months prior to Visit -1. For screening fai
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method