A Randomized, Double-blind, Multicentre, Controlled Trial Of Inhaled N-Acetylcysteine In Patients With The Early Stage Of Idiopathic Pulmonary Fibrosis In Japan

2010 ◽  
Author(s):  
Sakae A. Homma ◽  
Arata Azuma ◽  
Hiroyuki Taniguchi ◽  
Takashi Ogura ◽  
Yoshiro Mochizuki ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Early Stage ◽  
Controlled Trial ◽  
Double Blind

scholarly journals FDA-approved Antitussive Dextromethorphan Enhances Antifibrotic Effectiveness of Pirfenidone in Bleomycin-induced Mice and Patients with Idiopathic Pulmonary Fibrosis

2021 ◽  
Author(s):  
Nana Liu ◽  
Yubao Wang ◽  
Jie Huang ◽  
Yunze Du ◽  
Luqing Wei ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Adverse Reactions ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Randomized Controlled ◽  
Model Study ◽  
One Year

Abstract Background: We aimed to investigate whether dextromethorphan (DM), an antitussive agent, could improve the antifibrotic efficacy of pirfenidone in treating idiopathic pulmonary fibrosis, a fatal interstitial lung disease characterized by progressive and irreversible respiratory failure.Methods: A bleomycin-induced mouse pulmonary fibrosis model study and an open-label randomized clinical trial were performed to evaluate the effectiveness of pirfenidone combined with DM.Results: In the animal study, pirfenidone combined with DM protected the mice against bleomycin-induced pulmonary fibrosis with better capabilities than pirfenidone or DM alone, as indicated by lung histologic analysis and hydroxyproline levels. In the clinical study, pirfenidone plus DM markedly mitigated pulmonary function (FEV1 and FVC) decline and ameliorated chest HRCT imaging scores (ground glass opacities and reticulation) of patients with IPF compared with pirfenidone alone at one year after administration. There were no significant differences in adverse reactions between the pirfenidone-DM group and the pirfenidone group.Conclusions: Pirfenidone plus DM may be a better strategy to modify IPF than pirfenidone alone. The efficacy and safety of the combination of pirfenidone and DM for patients with IPF warrants further verification by a double-blind randomized controlled trial (RCT).

scholarly journals Randomised, double-blind, placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis

Thorax ◽  
2019 ◽  
Vol 74 (4) ◽  
pp. 346-353 ◽  
Author(s):  
Prosenjit Dutta ◽  
Wendy Funston ◽  
Helen Mossop ◽  
Vicky Ryan ◽  
Rhys Jones ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Pilot Trial ◽  
Acid Reflux ◽  
Forced Expiratory Volume ◽  
Double Blind ◽  
Cough Frequency ◽  
Randomised Controlled

BackgroundCough is a common, disabling symptom of idiopathic pulmonary fibrosis (IPF), which may be exacerbated by acid reflux. Inhibiting gastric acid secretion could potentially reduce cough. This study aimed to determine the feasibility of a larger, multicentre trial of omeprazole for cough in IPF, to assess safety and to quantify cough.MethodsSingle-centre, double-blind, randomised, placebo-controlled pilot trial of the proton pump inhibitor (PPI) omeprazole (20 mg twice daily for 3 months) in patients with IPF. Primary objectives were to assess feasibility and acceptability of trial procedures. The primary clinical outcome was cough frequency.ResultsForty-five participants were randomised (23 to omeprazole, 22 to placebo), with 40 (20 in each group) having cough monitoring before and after treatment. 280 patients were screened to yield these numbers, with barriers to discontinuing antacids the single biggest reason for non-recruitment. Recruitment averaged 1.5 participants per month. Geometric mean cough frequency at the end of treatment, adjusted for baseline, was 39.1% lower (95% CI 66.0% lower to 9.3% higher) in the omeprazole group compared with placebo. Omeprazole was well tolerated and adverse event profiles were similar in both groups, although there was a small excess of lower respiratory tract infection and a small fall in forced expiratory volume and forced vital capacity associated with omeprazole.ConclusionsA large randomised controlled trial of PPIs for cough in IPF appears feasible and justified but should address barriers to randomisation and incorporate safety assessments in relation to respiratory infection and changes in lung function.

Double-blind, Placebo-controlled Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis

2005 ◽  
Vol 171 (9) ◽  
pp. 1040-1047 ◽  
Author(s):  
Arata Azuma ◽  
Toshihiro Nukiwa ◽  
Eiyasu Tsuboi ◽  
Moritaka Suga ◽  
Shosaku Abe ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Phase 2 trial to assess lebrikizumab in patients with idiopathic pulmonary fibrosis

2020 ◽  
pp. 1902442
Author(s):  
Toby M. Maher ◽  
Ulrich Costabel ◽  
Marilyn K. Glassberg ◽  
Yasuhiro Kondoh ◽  
Takashi Ogura ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Primary Endpoint ◽  
Safety Profile ◽  
Controlled Trial ◽  
Phase 2 ◽  
Double Blind ◽  
Phase 2 Trial ◽  
Treatment Naïve ◽  
To Receive

This phase 2, randomised, double-blind, placebo-controlled trial evaluated the efficacy and safety of lebrikizumab, an interleukin-13 monoclonal antibody, alone or with background pirfenidone therapy, in patients with idiopathic pulmonary fibrosis (IPF).Patients with IPF aged ≥40 years with % predicted forced vital capacity (%FVC) 40%–100% and diffusing capacity for carbon monoxide 25%–90% and who were treatment-naive (Cohort A) or receiving pirfenidone (2403 mg·day−1; Cohort B) were randomised 1:1 to receive lebrikizumab 250 mg or placebo subcutaneously every 4 weeks. The primary endpoint was annualised rate of %FVC decline over 52 weeks.In Cohort A, 154 patients were randomised to receive lebrikizumab (n=78) or placebo (n=76). In Cohort B, 351 patients receiving pirfenidone were randomised to receive lebrikizumab (n=174) or placebo (n=177). Baseline demographics were balanced across treatment arms in both cohorts. The primary endpoint (annualised rate of %FVC decline) was not met in Cohort A (lebrikizumab versus placebo, −5.2% versus −6.2%; p=0.456) or Cohort B (lebrikizumab versus placebo, −5.5% versus −6.0%; p=0.557). In Cohort B, a non-statistically significant imbalance in mortality favouring combination therapy was observed (hazard ratio, 0.42 [95% CI, 0.17–1.04]). Pharmacodynamic biomarkers indicated lebrikizumab activity. The safety profile was consistent with that in previous studies of lebrikizumab and pirfenidone as monotherapies.Lebrikizumab alone or with pirfenidone was not associated with reduced %FVC decline over 52 weeks despite evidence of pharmacodynamic activity. Lebrikizumab was well tolerated with a favourable safety profile. These findings suggest that blocking IL-13 may not be sufficient to achieve a lung function benefit in patients with IPF.

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