Tag: Randomized

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A 12-week, Randomized, Parallel-Group, Proof-of-Concept Study of Tulobuterol Patch and Salmeterol Inhaler as Add-on Therapy in Adult-Onset Mild-to-Moderate Asthma.

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A 12-week, Randomized, Parallel-Group, Proof-of-Concept Study of Tulobuterol Patch and Salmeterol Inhaler as Add-on Therapy in Adult-Onset Mild-to-Moderate Asthma.

Clin Exp Pharmacol Physiol. 2016 Oct 8;:

Authors: Inoue H, Niimi A, Matsumoto H, Ito I, Oguma T, Otsuka K, Takeda T, Nakaji H, Tajiri T, Iwata T, Nagasaki T, Mishima M

Abstract
Patch formulation of tulobuterol has been used in asthma treatment as a long-acting ?2 -agonist (LABA) through sustained skin absorption. Its treatment efficacy, especially in small airways, remains poorly understood. The study aim was to investigate LABA add-on effects of tulobuterol patch (TP) and salmeterol inhaler (SA) on pulmonary function, asthma control, and health status. Patients who had adult-onset under-controlled asthma, despite taking inhaled corticosteroids, were enrolled in a randomized, open-label, parallel-group, proof-of-concept study of 12-week add-on treatment with TP (n = 16) or SA (n = 17). Spirometry, impulse oscillometry (IOS), exhaled nitric oxide levels, and clinical questionnaires of asthma control, health status (St. George’s Respiratory Questionnaire: SGRQ), and symptoms were evaluated every 4 weeks. Add-on treatment of SA significantly improved the spirometric indices of small airway obstruction (forced expiratory flow between 25% and 75% of FVC: FEF25-75 , and maximum expiratory flow at 25% of FVC: MEF25 ) and IOS indices of whole respiratory resistance (resistance at 5 Hz) as compared to TP. In intra-group comparisons, add-on treatment of TP improved the scores of the asthma control test and the total SGRQ, as well as the symptom and impact components of the SGRQ. SA add-on treatment improved FEV1 and IOS parameters of resistance at 20 Hz and reactance at 5 Hz. Neither of the treatments improved exhaled nitric oxide levels. In conclusion, add-on treatment of TP improved asthma control and health status, whereas SA improved pulmonary function measures associated with large and small airway involvement among patients with adult-onset mild-to-moderate asthma. This article is protected by copyright. All rights reserved.

PMID: 27718262 [PubMed – as supplied by publisher]

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A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma

Condition:   Asthma
Interventions:   Drug: QMF149;   Drug: QMF149;   Drug: MF 400;   Drug: MF 400;   Drug: salmeterol /fluticasone
Sponsor:   Novartis Pharmaceuticals
Not yet recruiting – verified September 2015

View full post on ClinicalTrials.gov: asthma | received in the last 14 days

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Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose ,With/ Without the Nebulized Budesonide For the Management of the Severe Asthma Exacerbation in the Emergency Room; A Randomized Controlled Trial.

Condition:   Bronchial Asthma
Interventions:   Drug: Intravenous magnesium sulfate;   Drug: Inhaled budesonide;   Drug: normal saline
Sponsor:   Hamad Medical Corporation
Recruiting – verified May 2015

View full post on ClinicalTrials.gov: asthma | received in the last 14 days

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A dose-ranging study of the bronchodilator effects of abediterol (LAS100977), a long-acting beta2-adrenergic agonist, in asthma; a Phase II, randomized study.

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A dose-ranging study of the bronchodilator effects of abediterol (LAS100977), a long-acting beta2-adrenergic agonist, in asthma; a Phase II, randomized study.

BMC Pulm Med. 2014 Nov 14;14(1):176

Authors: Singh D, Pujol H, Ribera A, Seoane B, Massana E, Astbury C, Ruiz S, de Miquel G

Abstract
BACKGROUND: Long-acting beta2-adrenergic agonists (LABAs) are recommended in combination with inhaled corticosteroids (ICSs) for asthma management. Abediterol is a novel, selective, potent, once-daily LABA in development for treatment of asthma and chronic obstructive pulmonary disease. This study aimed to determine abediterol doses with similar peak bronchodilatory effect to salbutamol 400 mug, and duration of action compatible with once-daily dosing in patients with persistent, stable asthma.
METHODS: This was a Phase II, randomized, double-blind, double-dummy, crossover, placebo-controlled, dose-ranging study (ClinicalTrials.gov NCT01425801) in 62 patients with mild-to-moderate asthma who were also receiving an ICS. Patients received single doses of abediterol 0.313, 0.625, 1.25, or 2.5 mug, salbutamol 400 mug, or placebo in the morning. Spirometry was performed up to 36 h post-dose; safety and tolerability were assessed throughout the study. The primary endpoint was change from baseline in peak forced expiratory volume in 1 s (FEV1). Additional endpoints included trough FEV1, normalized area under the FEV1 curve (FEV1 AUC) up to 24 h post-dose, and peak and trough forced vital capacity (FVC).
RESULTS: Abediterol produced dose-dependent improvements in peak FEV1 from baseline compared with placebo, from 0.274 (95%CI 0.221, 0.327) to 0.405 L (95%CI 0.353, 0.458) for abediterol 0.313 to 2.5 mug, respectively (p < 0.0001 all doses). Abediterol 0.625, 1.25, and 2.5 mug had similar magnitude of peak FEV1 effect to salbutamol. Dose-dependent changes from baseline in trough FEV1 versus placebo were 0.219 (95%CI 0.136, 0.302) to 0.400 L (95%CI 0.317, 0.483) for abediterol 0.313 to 2.5 mug, respectively (p < 0.0001). All abediterol doses achieved significant improvements versus placebo in FEV1 AUC 0-6, 0-12, and 0-24 h, and peak and trough FVC (p < 0.05). Less than 10% of patients experienced treatment-related adverse events for each dose of abediterol; most were mild to moderate in intensity and the most common were headache and nasopharyngitis. There were no clinically relevant changes in heart-rate.
CONCLUSIONS: Abediterol 0.625-2.5 mug provided dose-dependent, clinically and statistically significant bronchodilation versus placebo in patients with asthma, with a peak effect similar to salbutamol and duration of action compatible with once-daily dosing. All doses of abediterol were well tolerated.

PMID: 25398689 [PubMed – as supplied by publisher]

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The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.

Conditions:   Epistaxis;   Blood Pressure
Interventions:   Drug: Oxymetazoline 0.05%;   Drug: Phenylephrine 0.25%;   Drug: Lidocaine 1% plus epinephrine 1:100,000;   Drug: Bacteriostatic 0.9% NaCL
Sponsor:   Mayo Clinic
Recruiting – verified November 2014

View full post on ClinicalTrials.gov: asthma | received in the last 14 days

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A Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis in High Risk Patients

Condition:   Post-ERCP Acute Pancreatitis
Interventions:   Drug: Rectal Indomethacin;   Drug: Epinephrine
Sponsors:   Johns Hopkins University;   American Society for Gastrointestinal Endoscopy;   Asian Institute of Gastroenterology, India;   Postgraduate Institute of Medical Education and Research;   Apollo Gleneagles Hospitals, India
Not yet recruiting – verified April 2014

View full post on ClinicalTrials.gov: asthma | received in the last 14 days