Efficacy and Safety Study Comparing Respimat ® Budesonide With Turbohaler ® Budesonide in Symptomatic Adult Moderate to Severe Asthmatics Requiring Inhaled Corticosteroids and Bronchodilator Therapy

NCT02181335 | Completed Phase 3

• 1 other identifier: 1047.16
• Study Type: interventional
• Target: 684
• Locations: 0 countries
• Sites: N/A

Brief Summary

To establish that at least one of the two doses of Budesonide, as an ethanolic solution inhaled from the Respimat ® inhaler (100 and 200 mcg, 2 puffs bid) for a 12-week study period in symptomatic moderate to severe asthmatic patients, gives a therapeutic response, which is not inferior to that obtained from the dose of Budesonide inhaled from the Turbohaler ® (200 mcg, 2 puffs bid) and that the safety profile is at least as good

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change in mean weekly morning pre-dose Peak Expiratory Flow Rate (a.m. PEFR)

  Day1, 15, 29, 43, 57, 71, 85 (before intake of inhaled medication)

Secondary Outcomes (27)

• Change in Forced Expiratory Volume in one second (FEV1)

  Baseline, Day1, 15, 29, 43, 57, 71, 85

• Change in Forced Vital Capacity (FVC)

  Baseline, Day1, 15, 29, 43, 57, 71, 85

• Change in Peak Expiratory Flow Rate (PEFR)

  Baseline, Day1, 15, 29, 43, 57, 71, 85

• Changes in Mean weekly evening pre-dose PEFR (p.m. PEFR)

  Day1, 15, 29, 43, 57, 71, 85 (before intake of inhaled medication)

• Daily puffs of β2-agonists usage

  up to 85 days

Study Arms (3)

Respimat ® Budesonide low dose + Turbohaler® Placebo

EXPERIMENTAL

Drug: Respimat® Budesonide low dose; Drug: Placebo

Respimat ® Budesonide high dose + Turbohaler® Placebo

EXPERIMENTAL

Drug: Respimat® Budesonide high dose; Drug: Placebo

Turbohaler® Budesonide + Respimat Placebo®

ACTIVE COMPARATOR

Drug: Turbohaler® Budesonide; Drug: Placebo

Interventions

Respimat® Budesonide low dose DRUG

Respimat ® Budesonide low dose + Turbohaler® Placebo

Respimat® Budesonide high dose DRUG

Respimat ® Budesonide high dose + Turbohaler® Placebo

Turbohaler® Budesonide DRUG

Turbohaler® Budesonide + Respimat Placebo®

Placebo DRUG

Respimat ® Budesonide high dose + Turbohaler® Placebo; Respimat ® Budesonide low dose + Turbohaler® Placebo; Turbohaler® Budesonide + Respimat Placebo®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex aged 18 - 65 years (inclusive)
• Non-smokers or ex smokers. HAVING stopped smoking \>= 1 year prior to screening and with a smoking history of \<= 10 pack years
• Increase of asthma symptoms (wheeze, cough, shortness of breath, chest tightness) when exposure to any of the following stimuli: cold, dry air, dust, smoke, exercise and allergens
• Patients on a stable dosage of either
• mcg \<= BDP (beclomethasone dipropionate) \<= 1600 mcg daily or other inhaled steroid with or without inhaled long acting β2-agonists or oral xanthines at screening visit 1 for the past 4 weeks and short acting β2-agonists prn for the past 6 weeks or
• mcg \<= BDP \< 800 mcg daily or other inhaled steroid and inhaled long-acting β2-agonists (or oral xanthines), at screening visit 1 for the past 4 weeks and short acting β2-agonists prn for the past 6 weeks
• FEV1 \>= 60% but \<= 90 % predicted normal at visit 1 after withholding respiratory drugs as per section 4.2.1. Predicted normal values are based on the guidelines for standardized function testing of the European Community for Coal and Steel (ECCS)
• Males: FEV1 pred. (L) = 4.30 x Height (m) - 0.029 x Age (yrs) - 2.49
• Females: FEV1 pred. (L) = 3.95 x Height (m) - 0025 x Age (yrs) - 2.60
• Patient must demonstrate an improvement in FEV 1 \>= 12% above baseline and an absolute change of at least 200 ml within 30 minutes after administration of two puffs of salbutamol MDI (metered dose inhaler) (100 mcg per puff). Historical data within the previous 6 months are acceptable
• Patients must be able to be trained in the proper use of MDI, Turbohaler® and Respimat® and to perform technically satisfactory pulmonary function tests
• Patients must be willing and be able to give informed written consent prior to participation in the trial i.e. prior to pre-study wash-out of their usual pulmonary medications and are willing and able to complete the entire study as described in the protocol

You may not qualify if:

• Patients with a history of seasonal exacerbation of asthma suggesting seasonal asthma which would not be controlled by medication allowed in the protocol (see 4.2.2) and likely to occur during the time period that the patients will be in the study
• History of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
• Patients with a recent history (\<= 1 year) of myocardial infarction and/or (\<= 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy
• History of cancer within the past 5 years excluding treated basal cell carcinoma
• Patients with current psychiatric disorders which would interfere with the conduct of the trial
• Patients with history or presence of glaucoma and/or posterior subcapsular cataracts
• Patients with active tuberculosis with indication for treatment
• Patients with a history of cystic fibrosis, bronchiectasis, chronic bronchitis or emphysema
• Patients with active rhinitis requiring treatment with intranasal steroids and/or ketotifen
• Patients with upper respiratory tract infection in the past 6 weeks prior to screening visit 1 resulting in exacerbation of asthma symptoms
• Patients with unstable asthma as defined by any of the following: having required hospitalization for asthma exacerbation in the past 6 months, or a history of life-threatening asthma exacerbation resulted in respiratory failure and requiring intubation or ICU admission of longer than 24 hours in the past 5 years
• Patients with any of the abnormal laboratory values below:
• SGOT (serum glutamate oxaloacetate transaminase) \> 200% of the upper limit of the normal range
• SGPT (serum glutamate pyruvate transaminase) \> 200% of the upper limit of the normal range
• Creatinine \> 125% of the upper limit of the normal range

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 3, 2014
• Study Start: October 1, 1998
• Primary Completion: June 1, 2001
• Last Updated: July 18, 2014

Record last verified: 2014-07